FDA product code KXS: Radioimmunoassay, Methaqualone
KXS is the FDA product code for radioimmunoassay, methaqualone. It is a Class II device, regulated under 21 CFR 862.3630 and reviewed by the Clinical Toxicology panel. FDA has cleared 16 510(k) submissions under KXS, from 7 different applicants. The average 510(k) review took 51 days (median 39).
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Methaqualone |
| Device class | Class II |
| Regulation | 21 CFR 862.3630 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every KXS clearance
Top KXS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Syva Co. | 7 | 2000-01-27 |
| Roche Diagnostic Systems, Inc. | 2 | 1995-04-05 |
| Diagnostic Products Corp. | 2 | 1987-10-15 |
| Hoffmann-La Roche, Inc. | 2 | 1983-03-24 |
| Syva Co., Dade Behring, Inc. | 1 | 2001-05-10 |
2 more applicants have KXS clearances. See the full list in Caduvo.
Most recent KXS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K011164 | Syva Co., Dade Behring, Inc. | MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229 | 2001-05-10 | 24 |
| K993986 | Syva Co. | SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129UL | 2000-01-27 | 64 |
| K955676 | Beckman Instruments, Inc. | SYNCHRON SYSTEMS METHAQUALONE REAGENT | 1996-03-04 | 80 |
| K945187 | Roche Diagnostic Systems, Inc. | ROCHE ABUSCREEN ONLINE FOR METHAQUALONE | 1995-04-05 | 163 |
| K940123 | Diagnostic Reagents, Inc. | METHAQUALONE ENZYME IMMUNOASSAY | 1994-05-03 | 113 |
Recalls for KXS devices
openFDA lists no recalls for product code KXS.
Frequently asked questions
What is FDA product code KXS?
KXS is the FDA product code for radioimmunoassay, methaqualone. It is a Class II device, regulated under 21 CFR 862.3630 and reviewed by the Clinical Toxicology panel.
What device class is KXS?
Class II, regulation 21 CFR 862.3630. Typical premarket route: 510(k).
How long does a 510(k) take for product code KXS?
Across 16 cleared submissions the average was 51 days from receipt to decision (median 39).
Which companies have the most KXS clearances?
Syva Co. (7); Roche Diagnostic Systems, Inc. (2); Diagnostic Products Corp. (2); Hoffmann-La Roche, Inc. (2); Syva Co., Dade Behring, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KXS
- Run a recall and safety report across every KXS manufacturer
- Watch product code KXS 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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