Cleared Traditional

G-MARK (K880076) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K880076 · Bainbridge Laboratories, Inc. · Microbiology device
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Jul 1988
Decision
172d
Days
Class 2
Risk

K880076 is an FDA 510(k) clearance for the G-MARK. Classified as Antiserum, Coagglutination (direct) Neisseria Gonorrhoeae (product code LIC), Class II - Special Controls.

Submitted by Bainbridge Laboratories, Inc. (Bainbridge Island, US). The FDA issued a Cleared decision on July 1, 1988 after a review of 172 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3390 - 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 Bainbridge Laboratories, Inc. devices

Submission Details

510(k) Number K880076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1988
Decision Date July 01, 1988
Days to Decision 172 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 102d · This submission: 172d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LIC Antiserum, Coagglutination (direct) Neisseria Gonorrhoeae
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3390
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.