FDA 510(k) record · Prescription / point of care · Oral fluid
Healgen Accurate Oral Fluid Drug Test (8 drugs)
A saliva test for eight drugs, cleared in March 2026 for prescription point-of-care use. It is not a consumer home kit. Its FDA decision summary shows where readings become unreliable near each cutoff.
Read this first
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 (PDF page 1) |
| Applicant | Healgen Scientific, LLC |
| 510(k) number | K253705 (FDA database record) |
| Decision | Decision date 16 March 2026. Predicate: Premier Biotech OralTox® Oral Fluid Drug Test, K181305 (PDF page 4) |
| Intended use | For prescription point-of-care use only (PDF page 3). Not cleared for over-the-counter home use. |
| Sample type | Human oral fluid (saliva) |
| Format | Rectangular prism-shaped cup (PDF pages 4-5), with collection sponges and a saturation indicator (PDF page 14) |
| Analytes and cutoffs (ng/mL) | Amphetamine 50; cocaine (benzoylecgonine) 20; marijuana (delta-9-THC) 40; methadone 30; methamphetamine 50; opiates (morphine) 40; oxycodone 20; phencyclidine 10 (PDF pages 2-3) |
| Confirmation | Preliminary result only; LC-MS/MS is the preferred confirmatory method. Not intended to distinguish prescription use from abuse (PDF page 3) |
| 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
Precision near the cutoff
Design as stated on PDF page 5: three sites with three health care professionals each; negative oral fluid spiked with each drug, concentrations confirmed by LC/MS/MS; two runs a day for 25 days per device lot. Counts are shown as printed for lot 1; the source states no percentages.
| Analyte | Cutoff (ng/mL) | -100% | -75% | -50% | -25% | Cutoff | +25% | +50% | +75% | +100% | Tier | Source page / table |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| AMP | 50 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- | B | PDF page 5, table "AMP" |
| THC | 40 | 50-/0+ | 50-/0+ | 50-/0+ | 47-/3+ | 26-/24+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- | B | PDF page 6, table "THC" |
Comparison with LC-MS/MS on real samples
Design as stated on PDF page 16: 1,430 samples at six testing sites (four in the US) from nine lots, with one to thirteen health care professionals per site, compared with LC/MS/MS. Rows are copied from the tables as printed; the top row of each table is labelled "> -50% Cut off" in the source, which reads as a misprint for "above +50%".
| Analyte | Cutoff (ng/mL) | Drug free | -50% of cutoff to cutoff | Cutoff to +50% | Highest range | Tier | Source page / table |
|---|---|---|---|---|---|---|---|
| AMP | 50 | 833/833 negative | 30 negative / 1 positive of 31 (97%) | 2 negative / 12 positive of 14 (86%) | 95/95 positive | B | PDF page 16, table "AMP" |
| MET | 50 | 838/838 negative | 29 negative / 1 positive of 30 (97%) | 17/17 positive (100%) | 55/55 positive | B | PDF page 18, table "MET" |
| OXY | 20 | 854/854 negative | 16/16 negative (100%) | 1 negative / 38 positive of 39 (97%) | 56/56 positive | B | PDF page 18, table "OXY" |
| THC | 40 | 725/725 negative | 87 negative / 4 positive of 91 (96%) | 11 negative / 14 positive of 25 (56%) | 141/141 positive | B | PDF page 19, table "THC" |
The weakest result in the document is THC just above its cutoff: 11 of 25 samples read negative. The cocaine comparison table could not be read reliably from the PDF and is not reproduced here.
Limitations
- Prescription point-of-care device, not cleared for home use.
- Studies were run by the sponsor and reviewed by FDA; they are not independent.
- Readings near each cutoff split close to evenly in the precision study, and 11 of 25 real samples with THC just above 40 ng/mL read negative.
- A positive screen is preliminary and needs laboratory confirmation; the test cannot tell prescribed use from misuse.
Sources
- FDA 510(k) decision summary K253705 (U.S. Food and Drug Administration; opened and read 2026-10-21).
- FDA 510(k) database record K253705 (U.S. Food and Drug Administration; opened and read 2026-10-21).
- Applicant's 510(k) summary and FDA letter, K253705 (U.S. Food and Drug Administration, applicant document; opened and read 2026-10-21).
General education only, not medical, legal or purchasing advice. Found an error? See the corrections log.
Page last updated