FDA product code SGA: Biothreat Microbial Agent Nucleic Acid Detection Test
SGA is the FDA product code for biothreat microbial agent nucleic acid detection test. It is a Class II device, regulated under 21 CFR 866.4000 and reviewed by the Microbiology panel. FDA has cleared 2 510(k) submissions under SGA, 2 in the last five years. The average 510(k) review took 54 days (median 54); 54 days on average over the last three years.
Definition
A biothreat microbial agent nucleic acid detection test is a qualitative in vitro diagnostic device for the detection and identification of biothreat microbial agentassociated nucleic acids in human clinical specimens.
Classification
| Field | Value |
|---|---|
| Device name | Biothreat Microbial Agent Nucleic Acid Detection Test |
| Device class | Class II |
| Regulation | 21 CFR 866.4000 |
| Review panel | MI — Microbiology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
510(k) clearances per year for SGA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 91 |
| 2026 | 1 | 17 |
Compare with all 510(k) review times · Search every SGA clearance
Top SGA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Centers for Disease Control and Prevention | 2 | 2026-03-30 |
Most recent SGA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260812 | Centers for Disease Control and Prevention | Francisella tularensis Real-time PCR Assay | 2026-03-30 | 17 |
| K252072 | Centers for Disease Control and Prevention | Francisella tularensis Real-time PCR assay | 2025-09-30 | 91 |
Recalls for SGA devices
openFDA lists no recalls for product code SGA.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- G0476 — Infectious agent detection by nucleic acid (dna or rna); human papillomavirus (HPV), high-risk types (e.g., 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68) for cervical cancer screening, must be performed in addition to pap test
Frequently asked questions
What is FDA product code SGA?
SGA is the FDA product code for biothreat microbial agent nucleic acid detection test. It is a Class II device, regulated under 21 CFR 866.4000 and reviewed by the Microbiology panel.
What device class is SGA?
Class II, regulation 21 CFR 866.4000. Typical premarket route: 510(k).
How long does a 510(k) take for product code SGA?
Across 2 cleared submissions the average was 54 days from receipt to decision (median 54).
Which companies have the most SGA clearances?
Centers for Disease Control and Prevention (2).
Next steps
- Run an FDA pathway report with predicate devices for product code SGA
- Run a recall and safety report across every SGA manufacturer
- Watch product code SGA 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.
All Microbiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times