Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GTZ — Predicate Candidate Screening
105 FDA 510(k) clearances under this product code; the 50 most recent screened below.
68 daysmedian FDA review time
220 days90th percentile
105clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K012521 | BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST | Binax, Inc. | 2001-11-30 | 116 | 1 |
| K011709 | UNI-GOLD STREP A TEST KIT | Trinity Biotech, Plc | 2001-11-08 | 157 | 0 |
| K010523 | MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY A | Binax, Inc. | 2001-03-15 | 21 | 0 |
| K991726 | BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 | Binax, Inc. | 1999-08-27 | 99 | 0 |
| K971522 | ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II | Abbott Laboratories | 1998-03-03 | 312 | 1 |
| K962060 | STREP A OIA MAX | Biostar, Inc. | 1997-07-23 | 421 | 1 |
| K962296 | STREPTOLEX-STAT | Unipath , Ltd. | 1996-12-16 | 187 | 0 |
| K961423 | OSOM STREP A TEST | Wyntek Diagnostics, Inc. | 1996-10-11 | 182 | 0 |
| K962146 | EXCEL ONESTEP GROUP A STREP ANTIGEN MODULE TEST KIT | Excel Scientific, Inc. | 1996-10-07 | 126 | 0 |
| K955108 | CARDS Q.S. STREP A | Quidel Corp. | 1996-04-15 | 159 | 0 |
| K960712 | BINAX STREP A TEST | Binax, Inc. | 1996-03-22 | 30 | 0 |
| K952819 | ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) | Abbott Laboratories | 1996-01-26 | 220 | 0 |
| K954257 | QUICKVUE IN-LINE ONE STEP STREP A TEST (MODIFICATION) | Quidel Corp. | 1995-10-20 | 85 | 0 |
| K951542 | DIRECTIGEN 1-2-3 GROUP A STREP TEST | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995-10-20 | 200 | 0 |
| K952873 | MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION) | Medix Biotech, Inc. | 1995-09-08 | 94 | 0 |
| K935475 | QUIKSTRIP ONESTEP STREP A TEST IMMUNOCHROMA ASSAU | Syntron Bioresearch, Inc. | 1995-08-30 | 653 | 0 |
| K935554 | QUIKPAC II ONESTEP STREP A IMMUNOCHROMATOGRAPHIC ASSAY | Syntron Bioresearch, Inc. | 1995-08-30 | 651 | 0 |
| K945571 | ABBOTT TEST PACK STREP A TEST | Abbott Laboratories | 1995-08-14 | 280 | 0 |
| K934383 | PROLEX (STREPTOCCAL GROUPING LATEX KIT) | Pro-Lab, Inc. | 1995-01-27 | 505 | 0 |
| K942093 | REMEL RIM STREPTOCOCCUS GROUPING LATEX AGGLUTINATION TEST | Medical Diagnostic Technologies, Inc. | 1994-11-28 | 210 | 0 |
| K932482 | MEDIX BIOTECH BESTEST STREP A CAT. NO. BSF1010 | Medix Biotech, Inc. | 1994-07-18 | 420 | 0 |
| K934484 | QUICKVUE IN-LINE ONE-STEP STREP A TEST | Quidel Corp. | 1994-07-18 | 307 | 0 |
| K924461 | STREP A NEGATIVE CONTROL | Pacific Biotech, Inc. | 1993-12-02 | 456 | 0 |
| K924007 | QUIKPAC STREP A TEST | Syntron Bioresearch, Inc. | 1993-04-06 | 239 | 0 |
| K923673 | PRECISE STREP A | Becton Dickinson Advanced Diagnostics | 1992-09-28 | 68 | 0 |
| K922345 | TESTPACK PLUS STREP A | Abbott Laboratories | 1992-07-16 | 58 | 0 |
| K920565 | BBL STREP GROUPING KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-03-23 | 45 | 0 |
| K915758 | STREP A OIA | Biosearch Medical Products, Inc. | 1992-01-30 | 38 | 0 |
| K912889 | OIA STREP A | Biosearch Medical Products, Inc. | 1991-10-31 | 122 | 0 |
| K912868 | GROUP A STREP POSITIVE AND NEGATIVE CONTROLS | Quidel Corp. | 1991-08-07 | 40 | 0 |
| K911417 | ICON STREP B IMMUNOENZYMETRIC ASSAY | Hybritech, Inc. | 1991-07-24 | 114 | 0 |
| K910797 | STREPTEX ACID EXTRACTION KIT | Wellcome Diagnostics | 1991-03-29 | 31 | 0 |
| K903194 | REDITEST STREP A TEST KIT | Boehringer Mannheim Corp. | 1990-08-22 | 34 | 0 |
| K902038 | PATHO DX STREP D | Diagnostic Products Corp. | 1990-05-21 | 17 | 0 |
| K901274 | TESTPACK PLUS STREP A | Abbott Laboratories | 1990-05-11 | 53 | 0 |
| K896265 | QUIDEL GROUP B STREP TEST | Quidel Corp. | 1990-02-16 | 108 | 0 |
| K897083 | VENTRESIGN STREP A TEST | Ventrex Laboratories, Inc. | 1990-01-22 | 33 | 0 |
| K896221 | CARDS O.S.(TM) STREP A | Pacific Biotech, Inc. | 1989-12-13 | 44 | 0 |
| K896109 | IMMUNOCARD STREP A TEST | Disease Detection International, Inc. | 1989-11-29 | 37 | 0 |
| K895103 | ACCUPROBE ENTEROCOCCUS CULTURE CONFIRMATION | Gen-Probe, Inc. | 1989-11-29 | 106 | 0 |
| K894711 | ACCUPROBE GROUP B STREPTOCOCCUS CULTURE CONFIRMA. | Gen-Probe, Inc. | 1989-11-14 | 111 | 0 |
| K894122 | LEECO VIS-DISK STREP-A (EIA) | Leeco Diagnostics, Inc. | 1989-08-15 | 64 | 0 |
| K893422 | CLEARVIEW STREP A | Unipath , Ltd. | 1989-06-23 | 52 | 0 |
| K890840 | VISUWELL GROUP A STREPTOCOCCUS DETECTION KIT | Adi Diagnostics, Inc. | 1989-03-27 | 34 | 0 |
| K885003 | BACTIGEN(R) GROUP B STREPTOCOCCUS TEST | Armkel, LLC | 1989-02-07 | 68 | 0 |
| K884750 | GROUP A STREP, BETA-STREP | Ampcor, Inc. | 1988-12-22 | 38 | 0 |
| K883999 | QUIDEL GROUP A STREP TEST | Quidel Corp. | 1988-10-12 | 23 | 0 |
| K881457 | KODAK SURECELL STREP A TEST KIT | Eastman Kodak Company | 1988-04-21 | 15 | 0 |
| K880483 | V-TREND STREP A TEST | Texas Immunology, Inc. | 1988-04-12 | 67 | 0 |
| K880460 | TARGET STREP A | V-Tech, Inc. | 1988-03-03 | 29 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda