FDA 510(k) record · Over the counter (home use) · Oral fluid
Healgen Accurate Oral Fluid Drug Test COT/THC
A saliva test cleared for home use in February 2026. It screens for two substances only: marijuana (THC) and cotinine, a marker of tobacco or nicotine use. It does not test for any other drug.
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P in the Cup does not perform the testing or certify these products. The figures below come from one source document and describe one study design. They are not a general accuracy rating, and a screen result is preliminary until a laboratory confirms it. See what accuracy figures mean.
Identity
Exactly what this record covers
| Field | As stated in the source |
|---|---|
| Device | Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test (PDF page 1) |
| Applicant | Healgen Scientific LLC (the FDA database record reads "Healgen Scientific,, LLC") |
| 510(k) number | K252523 (FDA database record) |
| Decision | Decision date 12 February 2026. Purpose stated on PDF page 1: "Over-the-counter claim for predicate device k223162" |
| Intended use | Over the counter (PDF page 2, "OTC – Over-the-Counter"). The 2023 device K223162 was cleared for prescription use (comparison table, PDF page 4). |
| Sample type | Human oral fluid (saliva) |
| Kit contents | Holder cartridge with cup insert, test strips and reagent pads; oral fluid (saliva) collection swab (PDF page 3) |
| Analytes and cutoffs (ng/mL) | Marijuana (THC), calibrator delta-9-tetrahydrocannabinol: 40. Cotinine (COT), calibrator (-) cotinine: 30 (PDF page 2) |
| Confirmation | Preliminary result only; an alternative laboratory test must confirm it, with LC/MS the preferred method (PDF page 2) |
| Where the bench data come from | Precision, specificity, cross-reactivity and method comparison were "established in K223162" (PDF pages 5-6). Only the lay-user studies are new in this clearance. |
| Buy link | No verified retailer link. No retailer listing has been matched to this exact device and SKU. |
| Last reviewed | 21 October 2026 |
Analyte-level results
Lay users reading the test
Design as stated on PDF page 6: at three sites, 160 lay users each tested a spiked oral-fluid sample, then the same 160 were paired to test each other, and results were compared with LC/MS. A further THC study at another site had 98 lay users testing a partner; no one self-tested.
| Level (% of 40 ng/mL cutoff) | LC-MS (ng/mL) | Negative | Positive | Agreement | Tier | Source page / table |
|---|---|---|---|---|---|---|
| -100% | 0.00 | 20 | 0 | 100% | B | PDF pages 6-7, "Data Summary According to THC Concentrations" |
| -75% | 9.5 | 20 | 0 | 100% | B | PDF pages 6-7, "Data Summary According to THC Concentrations" |
| -50% | 20.7 | 20 | 0 | 100% | B | PDF pages 6-7, "Data Summary According to THC Concentrations" |
| -25% | 30.2 | 19 | 1 | 95% | B | PDF pages 6-7, "Data Summary According to THC Concentrations" |
| +25% | 51.4 | 0 | 20 | 100% | B | PDF pages 6-7, "Data Summary According to THC Concentrations" |
| +50% | 59.2 | 0 | 20 | 100% | B | PDF pages 6-7, "Data Summary According to THC Concentrations" |
| +75% | 68.3 | 0 | 20 | 100% | B | PDF pages 6-7, "Data Summary According to THC Concentrations" |
| +100% | 81.5 | 0 | 20 | 100% | B | PDF pages 6-7, "Data Summary According to THC Concentrations" |
| Concentration range | Negative | Positive | Total | Correct (as printed) | Tier | Source page / table |
|---|---|---|---|---|---|---|
| Drug free | 155 | 0 | 155 | 100% | B | PDF page 7, native sample "Data Summary According to THC Concentrations" |
| Below -50% of cutoff | 8 | 0 | 8 | 100% | B | PDF page 7, native sample "Data Summary According to THC Concentrations" |
| -50% of cutoff to cutoff | 17 | 1 | 18 | 94.4% | B | PDF page 7, native sample "Data Summary According to THC Concentrations" |
| Cutoff to +50% | 5 | 33 | 38 | 86.8% | B | PDF page 7, native sample "Data Summary According to THC Concentrations" |
| Above +50% | 0 | 39 | 39 | 100% | B | PDF page 7, native sample "Data Summary According to THC Concentrations" |
Summed, the real-sample table gives 252 correct of 258 (97.7%). The misses cluster near the cutoff: 5 of 38 samples just above it read negative. The same page reports cotinine results (for example 1 negative / 12 positive of 13 just above its cutoff), which are not shown here because cotinine is a tobacco marker, not a drug of abuse.
Data carried over from the 2023 device
The 2023 decision summary for K223162 holds the precision and method-comparison data this clearance relies on. Its THC precision table (PDF page 6, lot 1) shows 47 negative / 3 positive of 50 at 25% below the cutoff and 49 positive / 1 negative of 50 at 25% above it. Its method comparison tested 126 THC samples against LC/MS/MS (PDF page 10). In 2023 only the cotinine test was cleared for over-the-counter use.
Limitations
- Screens for marijuana (THC) and cotinine only. A negative result says nothing about other drugs.
- The lay-user studies were run by the sponsor and reviewed by FDA; they are not independent.
- Precision and method-comparison data come from the 2023 device K223162, not from new testing for this clearance.
- Results just above the 40 ng/mL THC cutoff were the least reliable: 5 of 38 real samples in that range read negative.
- A positive screen is preliminary and needs laboratory confirmation.
Sources
- FDA 510(k) decision summary K252523 (U.S. Food and Drug Administration; opened and read 2026-10-21).
- FDA 510(k) database record K252523 (U.S. Food and Drug Administration; opened and read 2026-10-21).
- Applicant's 510(k) summary and FDA letter, K252523 (U.S. Food and Drug Administration, applicant document; opened and read 2026-10-21).
- FDA 510(k) decision summary K223162 (U.S. Food and Drug Administration; opened and read 2026-10-21).
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