FDA product code GTQ: Antistreptolysin - Titer/Streptolysin O Reagent
GTQ is the FDA product code for antistreptolysin - titer/streptolysin o reagent. It is a Class I device, regulated under 21 CFR 866.3720 and reviewed by the Microbiology panel. FDA has cleared 37 510(k) submissions under GTQ, from 25 different applicants. The average 510(k) review took 94 days (median 63). FDA has posted 4 recalls for GTQ devices.
Classification
| Field | Value |
|---|---|
| Device name | Antistreptolysin - Titer/Streptolysin O Reagent |
| Device class | Class I |
| Regulation | 21 CFR 866.3720 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Top GTQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biokit USA, Inc. | 4 | 1991-01-25 |
| Behring Diagnostics, Inc. | 3 | 1993-06-28 |
| Beckman Instruments, Inc. | 3 | 1993-06-15 |
| Kallestad Diag, A Div. of Erbamont, Inc. | 3 | 1991-06-17 |
| Analytical Products, Inc. | 3 | 1984-08-23 |
20 more applicants have GTQ clearances. See the full list in Caduvo.
Most recent GTQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K052645 | Ortho-Clinical Diagnostics | VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873; | 2005-12-14 | 79 |
| K953437 | Olympus America, Inc. | OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENT | 1995-10-20 | 91 |
| K915742 | Behring Diagnostics, Inc. | TURBIQUANT ASL | 1993-06-28 | 553 |
| K926236 | Beckman Instruments, Inc. | BECKMAN ANTI-STREPTOLYSIN O KIT | 1993-06-15 | 186 |
| K924247 | J.S. Medical Assoc. | ACCUTEX ASO LATEX TEST | 1992-12-07 | 105 |
Recalls for GTQ devices
4 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2008-11-18.
Frequently asked questions
What is FDA product code GTQ?
GTQ is the FDA product code for antistreptolysin - titer/streptolysin o reagent. It is a Class I device, regulated under 21 CFR 866.3720 and reviewed by the Microbiology panel.
What device class is GTQ?
Class I, regulation 21 CFR 866.3720. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GTQ?
Across 37 cleared submissions the average was 94 days from receipt to decision (median 63).
Which companies have the most GTQ clearances?
Biokit USA, Inc. (4); Behring Diagnostics, Inc. (3); Beckman Instruments, Inc. (3); Kallestad Diag, A Div. of Erbamont, Inc. (3); Analytical Products, Inc. (3).
Have GTQ devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2008-11-18.
Next steps
- Run an FDA pathway report with predicate devices for product code GTQ
- Run a recall and safety report across every GTQ manufacturer
- Watch product code GTQ 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.