Cleared Traditional

K920143 - TB SUSCEPTIBILITY QUADS I AND II

K920143 is an FDA 510(k) clearance for TB SUSCEPTIBILITY QUADS I AND II, manufactured by Remel Co.. The device is a Class 2 Microbiology device with product code MJD cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K920143 · Remel Co. · Microbiology device
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Jun 1992
Decision
148d
Days
Class 2
Risk

K920143 is an FDA 510(k) clearance for the TB SUSCEPTIBILITY QUADS I AND II. Classified as Culture Media, Antimycobacteria, Susceptibility Test (product code MJD), Class II - Special Controls.

Submitted by Remel Co. (Lenexa, US). The FDA issued a Cleared decision on June 9, 1992 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1700 - 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 Remel Co. devices

FDA 510(k) Submission Details - K920143

510(k) Number K920143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1992
Decision Date June 09, 1992
Days to Decision 148 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 102d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MJD Device Classification - Class 2, Special Controls

Product Code MJD Culture Media, Antimycobacteria, Susceptibility Test
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1700
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.