Cleared Traditional

K880076 - G-MARK

K880076 is an FDA 510(k) clearance for G-MARK, manufactured by Bainbridge Laboratories, Inc.. The device is a Class 2 Microbiology device with product code LIC cleared through the Traditional 510(k) pathway after a 172-day FDA review.

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

FDA 510(k) Submission Details - K880076

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.

LIC Device Classification - Class 2, Special Controls

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.