Cleared Traditional

YHLAMYDIA CF ANTIGEN AND CONTROL ANTIGEN (K872700) - FDA 510(k) Clearance

Class I Microbiology device.

K872700 · Sita, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1987
Decision
100d
Days
Class 1
Risk

K872700 is an FDA 510(k) clearance for the YHLAMYDIA CF ANTIGEN AND CONTROL ANTIGEN. Classified as Antigen, Cf, Psittacosis (chlamydia Group) (product code GPW), Class I - General Controls.

Submitted by Sita, Inc. (Allentown, US). The FDA issued a Cleared decision on October 15, 1987 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3120 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Sita, Inc. devices

Submission Details

510(k) Number K872700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1987
Decision Date October 15, 1987
Days to Decision 100 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 102d · This submission: 100d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GPW Antigen, Cf, Psittacosis (chlamydia Group)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3120
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.