Cleared Traditional

PHADEBACT MONOCLONAL GC TEST, MODIFICATION (K921075) - FDA 510(k) Clearance

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

K921075 · Karo Bio Diagnostics AB · Microbiology device
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May 1992
Decision
84d
Days
Class 2
Risk

K921075 is an FDA 510(k) clearance for the PHADEBACT MONOCLONAL GC TEST, MODIFICATION. Classified as Antiserum, Coagglutination (direct) Neisseria Gonorrhoeae (product code LIC), Class II - Special Controls.

Submitted by Karo Bio Diagnostics AB (S-141 44 Huddinge, Sweden, SC). The FDA issued a Cleared decision on May 22, 1992 after a review of 84 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Karo Bio Diagnostics AB devices

Submission Details

510(k) Number K921075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1992
Decision Date May 22, 1992
Days to Decision 84 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 102d · This submission: 84d
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.