FDA product code PJD: Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device
PJD is the FDA product code for oral fluid drugs of abuse and alcohol test specimen collection device. It is a Class II device, regulated under 21 CFR 862.1675 and reviewed by the Clinical Chemistry panel. FDA has cleared 9 510(k) submissions under PJD, 2 in the last five years, from 5 different applicants. The average 510(k) review took 161 days (median 123).
Definition
Intended for use in the collection, preservation, and transport of oral fluid specimens for drugs of abuse or alcohol testing.
Classification
| Field | Value |
|---|---|
| Device name | Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device |
| Device class | Class II |
| Regulation | 21 CFR 862.1675 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
510(k) clearances per year for PJD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 269 |
| 2020 | 1 | 123 |
| 2023 | 2 | 144 |
Compare with all 510(k) review times · Search every PJD clearance
Top PJD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Immunalysis Corporation | 4 | 2023-11-21 |
| Epitope, Inc. | 2 | 1998-02-13 |
| OraSure Technologies, Inc. | 1 | 2001-06-06 |
| Osborn Laboratories, Inc. | 1 | 1999-01-13 |
| Saliva Diagnostic Systems, Inc. | 1 | 1995-08-21 |
Most recent PJD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K232898 | Immunalysis Corporation | Quantisal Oral Fluid Collection Device | 2023-11-21 | 64 |
| K223781 | Immunalysis Corporation | Quantisal II Oral Fluid Collection Device | 2023-07-28 | 224 |
| K200801 | Immunalysis Corporation | Quantisal Oral Fluid Collection Device | 2020-07-28 | 123 |
| K183048 | Immunalysis Corporation | Quantisal II Oral Fluid Collection Device | 2019-07-29 | 269 |
| K011057 | OraSure Technologies, Inc. | INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX | 2001-06-06 | 61 |
Recalls for PJD devices
openFDA lists no recalls for product code PJD.
Frequently asked questions
What is FDA product code PJD?
PJD is the FDA product code for oral fluid drugs of abuse and alcohol test specimen collection device. It is a Class II device, regulated under 21 CFR 862.1675 and reviewed by the Clinical Chemistry panel.
What device class is PJD?
Class II, regulation 21 CFR 862.1675. Typical premarket route: 510(k).
How long does a 510(k) take for product code PJD?
Across 9 cleared submissions the average was 161 days from receipt to decision (median 123).
Which companies have the most PJD clearances?
Immunalysis Corporation (4); Epitope, Inc. (2); OraSure Technologies, Inc. (1); Osborn Laboratories, Inc. (1); Saliva Diagnostic Systems, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PJD
- Run a recall and safety report across every PJD manufacturer
- Watch product code PJD for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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