Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart D — Serological Reagents](/submissions/MI/subpart-d%E2%80%94serological-reagents) → [21 CFR 866.3986](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3986) → SBZ — Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users

# SBZ · Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users

_Microbiology · 21 CFR 866.3986 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/SBZ

## Overview

- **Product Code:** SBZ
- **Device Name:** Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users
- **Regulation:** [21 CFR 866.3986](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3986)
- **Device Class:** 2
- **Review Panel:** [Microbiology](/submissions/MI)
- **3rd-party reviewable:** yes

## Identification

The First To Know Syphilis Test is a single-use, qualitative, rapid membrane immunochromatographic assay for the detection of Treponema pallidum (syphilis) antibodies in human capillary whole blood. It is intended for over-the-counter (OTC) consumer use in individuals suspected of syphilis. The test is visually read and does not require software, instrumentation, or additional reagents.

## Classification Rationale

Class II (special controls). The device is classified as Class II under 21 CFR 866.3986, as general controls alone are insufficient to provide reasonable assurance of safety and effectiveness, but the risks can be mitigated by special controls.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [DEN230090](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/SBZ/DEN230090.md) | First To Know Syphilis Test | Nowdiagnostics | Aug 16, 2024 | DENG |

## Top Applicants

- Nowdiagnostics — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/SBZ](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/SBZ)

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