510(k) K150358
- Device
- Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System
- Applicant
- GOLD STANDARD DIAGNOSTICS
- 510(k) number
- K150358
- Product code
- GMQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-11-12
- Date received
- 2015-02-12
- Regulation
- 866.3820
- Classification name
- Antigens, Nontreponemal, All
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- NAPOLEON MONCE
- Address
- 2851 Spafford Davis CA US 95618 95618
FDA Registration Numbers#
- 8032314
- 3003750284
- 1119779
- 3017505309
- 1616487
- 1832216
- 3007208259
- 2242436
- 8010096
- 2029372
- 1641328
- 3032705
- 1649661
- 2915274
- 2250030
Source Documents#
Other 510(k) Records For Product Code GMQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250249 | Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System | Gold Standard Diagnostics, LLC | 2025-10-10 |
| K201438 | ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer | Arlington Scientific, Inc. (Asi) | 2020-10-21 |
| K182391 | ASI Automated ASI RPR Test for Syphilis on the ASI Evolution | Arlington Scientific, Inc. (Asi) | 2018-11-30 |
| K173376 | ASI Evolution | Arlington Scientific, Inc. (Asi) | 2018-06-14 |
| K000687 | THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST | Beacon Biologicals, Inc. | 2000-06-12 |
| K993633 | SYNTHETIC VDRL ANTIGEN | Centers for Disease Control and Prevention | 2000-02-23 |
| K992124 | AVANTI POLAR LIPIDS VDRL ANTIGEN SLIDE TEST KIT WITH 10 X 0.5 ML AMPULES, AVANTI POLAR LIPIDS BULK BDRL ANTIGEN, AVANTI | Avanti Polar Lipids, Inc. | 1999-09-20 |
| K954994 | TRUST | Guardian Scientific, Corp. | 1996-10-18 |
| K955136 | RPR CARD TEST KIT | Remel, L.P. | 1996-07-29 |
| K952802 | VISUWELL REAGIN II | Biomira Diagnostics, Inc. | 1996-05-23 |
| K910541 | BIOKIT RPR | Biokit USA, Inc. | 1991-10-18 |
| K904496 | CROMATEST SYPHILIS DIAGNOSTIC | Biotrax, Inc. | 1991-07-24 |
| K900338 | VISUWELL(R) REAGIN TEST (MODIFICATION) | Adi Diagnostics, Inc. | 1990-04-10 |
| K880144 | STANBIO SYPHILIS RPR TEST, NO. 1170 | Stanbio Laboratory | 1988-05-23 |
| K880165 | TRUST RPR TEST FOR SYPHILIS IN SERUM OR PLASMA | Ampcor, Inc. | 1988-03-30 |
Legacy Summary#
summary
FDA Review#
Decision Summary