CLIA-Waived Tests: What Counts and How to Check
A CLIA-waived test is a test system FDA has judged simple enough, or safe enough, to run without the nonwaived rule book. The waiver attaches to the system in your hands, not to the analyte, so the check is a lookup in FDA's database. Here is what qualifies, how to look it up, and what a waived test still asks of you. Read from 42 CFR 493, FDA and CMS on 23 October 2026.
What makes a test waived
CLIA sorts every test into one of three levels: waived, moderate complexity (which includes provider-performed microscopy) and high complexity (§ 493.5(a)). Waived is the lightest. Under § 493.15(b), waived test systems are "simple laboratory examinations and procedures" that meet one of three tests:
- (b)(1) Are cleared by FDA for home use.
- (b)(2) Employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible.
- (b)(3) Pose no reasonable risk of harm to the patient if the test is performed incorrectly.
The word that matters is or. A test cleared for home use is waived on that ground alone. A test used only in clinics has to show FDA it is simple and accurate in untrained hands, or low risk if run wrong.
Note what "waived" does not mean. It is not a waiver from CLIA. A site that runs even one waived test on patient specimens is a laboratory under § 493.2 and needs a certificate, most often the Certificate of Waiver.
The nine tests written into the rule
§ 493.15(c) still lists nine. The section was first published in 1992 (57 FR 7139), and the list reads like an office lab of that time: dipsticks, a copper sulfate drop, a spun hematocrit.
- Dipstick or tablet reagent urinalysis, non-automated: bilirubin, glucose, hemoglobin, ketone, leukocytes, nitrite, pH, protein, specific gravity, urobilinogen
- Fecal occult blood, non-automated
- Ovulation tests: visual color comparison tests for human luteinizing hormone
- Urine pregnancy tests: visual color comparison tests
- Erythrocyte sedimentation rate, non-automated
- Hemoglobin by copper sulfate, non-automated
- Blood glucose by glucose monitoring devices cleared by the FDA specifically for home use
- Spun microhematocrit
- Hemoglobin by single analyte instruments with self-contained or component features, direct measurement and readout
Most waived testing today is not on this list. The rule's own paragraph (d) lets HHS add tests, and FDA now does it test system by test system. FDA's Currently Waived Analytes page listed 156 analytes when we read it on 23 October 2026, from urine hCG to SARS-CoV-2.
How a test system becomes waived
FDA's CLIA Categorizations page names the routes. Tests waived by regulation under § 493.15(c), or "cleared or approved for home use, are categorized as waived." Every other test is scored as moderate or high complexity after FDA clears or approves it.
A manufacturer can then ask to move a moderate complexity test down. That request is a CLIA Waiver by Application, and its tracking number starts with CW plus six digits. The manufacturer must show the test has "an insignificant risk of an erroneous result" in the hands of its intended users, with clinical studies at intended use sites. Other categorizations are tracked as CLIA Records, numbered CR. You will see both prefixes in the database.
The waiver belongs to the test system
FDA waives a specific test system, with its specimen type, not the analyte in general. A waived strep A strip does not make every strep A test waived. How the scoring works for the rest, and why an uncategorized test counts as high complexity, is in waived, moderate and high complexity testing.
Takeaway
How to look up a test system
The source is FDA's CLIA database. CMS's own brochure sends labs there, and FDA adds new categorizations "at the next weekly update." The steps, as the database worked on 23 October 2026:
- Search by the system, not the analyte. Type the manufacturer or kit name in Test System / Manufacturer. FDA's hint: "enter a single word (e.g., Analyzer) or an exact phrase". Use the brand word on the box, not the full product name.
- Narrow it if the list is long. The form also takes an Analyte Name, a Document Number, a Complexity (High, Moderate or Waived), an Analyte Specialty and an effective date range.
- Read the results row. Each row shows the test system, Document, Parent, Analyte, Analyte Specialty, Complexity and Effective Date.
- Match the row to your kit. Open the record and compare the name, the qualifier and the specimen type with your package insert. When the record names a specimen, the waiver covers that specimen.
- Keep a copy. Print or save the record with the date you read it. CLIA does not ask for this, but it answers the question in seconds when a surveyor or payer does.
| Field | What it tells you |
|---|---|
| Test System Name | Manufacturer, then the system and kit name. Qualifiers in braces and parentheses name the assay or the specimen, such as throat swabs. |
| Document Number | The categorization record: a CR, CW or premarket number. |
| Parent Document Number | The 510(k) or PMA the system was cleared or approved under. |
| Analyte Name | What the system measures. One system can carry several analytes, each with its own row. |
| Analyte Specialty | The CLIA specialty, such as Bacteriology or General Chemistry. |
| Complexity | WAIVED, MODERATE or HIGH. This is the answer you came for. |
| Effective Date | The day the categorization took effect. |
Why the system and not the analyte? Because the same analyte sits at every level. Three analyte searches on 23 October 2026:
| Analyte search | Waived | Moderate | High |
|---|---|---|---|
| A1c | 37 | 255 | 29 |
| Prothrombin | 34 | 318 | 29 |
| Streptococcus | 161 | 177 | 153 |
Records, not products: one system with two analytes is two rows. FDA CLIA database, searched 2026-10-23.
Not in the database?
Common waived tests in physician office labs
These are the groups an office lab usually runs, with the analyte names as FDA prints them on its waived list. Each name only means that at least one test system for it is waived. It does not make your system waived.
| Group | Waived analytes on FDA's list |
|---|---|
| Urine | Urine qualitative dipstick (glucose, ketone, nitrite, pH and others); HCG, urine |
| Diabetes | Glucose monitoring devices; Glycosylated hemoglobin (Hgb A1c) |
| Lipids | Cholesterol; HDL cholesterol; LDL cholesterol; Triglyceride |
| Blood counts | Hemoglobin; Spun microhematocrit; Erythrocyte sedimentation rate, nonautomated |
| Anticoagulation | Prothrombin time (PT) |
| Respiratory | Streptococcus, group A; Influenza A/B; Respiratory syncytial virus; SARS-CoV-2 |
| Other infections | Infectious mononucleosis antibodies (Mono); Helicobacter pylori; HIV-1 and HIV-2 antibodies; Hepatitis C virus antibody |
| Stool | Fecal occult blood |
Microscopy is the usual surprise. A wet mount or a urine sediment is not waived. It is provider-performed microscopy, a subcategory of moderate complexity with its own certificate.
Takeaway
Waived still means following the instructions
CLIA asks two things of a lab eligible for a certificate of waiver. The first is the one that decides whether the test stays waived at all.
Laboratories eligible for a certificate of waiver must— (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part.
The package insert is the procedure. FDA judged the test simple on the steps the insert gives: that specimen, those timings, that reading window, that storage range. Change a step and you are no longer running the system FDA reviewed.
CMS's CLIA Certification brochure (revised March 2026) adds a warning about the laminated cards that come in many kits: "the quick reference guide is only a synopsis of the package insert and cannot be used without the manufacturer's instructions." It also asks that instructions be "current for the test system in use and are available to the individuals performing the test." When a new lot ships with a revised insert, the old one comes off the wall.
What the insert usually sets
- Specimen: the type, the collection device and how long it may wait.
- Storage: the temperature range, and how long an opened kit or vial lasts.
- Timing: when to read, and when a result is too late to read.
- Quality control: which controls to run, and when. For a waived test the insert sets the QC schedule (how often to run QC covers it).
- Limitations: who the test is not for, and which results need a confirmatory test.
What CLIA does not ask of waived tests
The nonwaived rule book stops at the waived line. Even in a lab that also runs moderate or high complexity tests, the proficiency testing enrollment rules and subparts J, K and M (facility administration, quality systems, personnel) "are not applicable to the waived tests" (§ 493.25(d); the same in § 493.20(c)).
- No proficiency testing. PT is required for nonwaived testing (CLIA proficiency testing).
- No CLIA competency assessment. CMS: "For laboratories only performing waived testing, CLIA does not require a competency assessment for Testing Personnel (TP), however, it is good laboratory practice" (CMS competency brochure).
- No federal personnel qualifications for the people who run waived tests.
Lighter, not empty
The lab still needs its certificate, still follows every insert, and can still be inspected. What a waiver lab owes, and when it gets a visit, is in the Certificate of Waiver guide. Medicare claims for waived tests may also need the QW modifier: "QW denotes a CLIA waiver test" (Claims Processing Manual, ch. 16).