Cleared Traditional

K922926 - API UNISCEPT KB/TYPE 2 AND 3

K922926 is an FDA 510(k) clearance for API UNISCEPT KB/TYPE 2 AND 3, manufactured by Analytical Products, Inc.. The device is a Class 2 Microbiology device with product code JWY cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K922926 · Analytical Products, Inc. · Microbiology device
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Oct 1992
Decision
118d
Days
Class 2
Risk

K922926 is an FDA 510(k) clearance for the API UNISCEPT KB/TYPE 2 AND 3. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Analytical Products, Inc. (Plainview, US). The FDA issued a Cleared decision on October 13, 1992 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1640 - 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 Analytical Products, Inc. devices

FDA 510(k) Submission Details - K922926

510(k) Number K922926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1992
Decision Date October 13, 1992
Days to Decision 118 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
16d slower than avg
Panel avg: 102d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JWY Device Classification - Class 2, Special Controls

Product Code JWY Manual Antimicrobial Susceptibility Test Systems
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1640
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.

Regulatory Peers - JWY Manual Antimicrobial Susceptibility Test Systems

All 394
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K922926.
DRIED GRAM-NEGATIVE AND POSITIVE MIC/COMBO PANELS
K922458 · Baxter Healthcare Corp · Dec 1992
API UNISCEPT MIC/TYPE 2 AND 3 AND MICRO MIC
K923684 · Analytical Products, Inc. · Dec 1992
ANTIMICROBIAL SUSCEPTIBILITY TEST
K924500 · Alamar Biosciences Laboratory, Inc. · Nov 1992
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
K922780 · Alamar Biosciences Laboratory, Inc. · Aug 1992
ANTIMICROBIAL SUSCETIBILITY TEST PANEL
K922003 · Alamar Biosciences Laboratory, Inc. · Aug 1992
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
K922168 · Alamar Biosciences Laboratory, Inc. · Jul 1992