Cleared Traditional

K872700 - YHLAMYDIA CF ANTIGEN AND CONTROL ANTIGEN

K872700 is an FDA 510(k) clearance for YHLAMYDIA CF ANTIGEN AND CONTROL ANTIGEN, manufactured by Sita, Inc.. The device is a Class 1 Microbiology device with product code GPW cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K872700 · Sita, Inc. · Microbiology device
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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

FDA 510(k) Submission Details - K872700

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.

GPW Device Classification - Class 1, General Controls

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.