Cleared Traditional

K924814 - API 20E/UNISCEPT 20E

K924814 is an FDA 510(k) clearance for API 20E/UNISCEPT 20E, manufactured by Analytical Products, Inc.. The device is a Class 1 Microbiology device with product code JSS cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K924814 · Analytical Products, Inc. · Microbiology device
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Mar 1993
Decision
167d
Days
Class 1
Risk

K924814 is an FDA 510(k) clearance for the API 20E/UNISCEPT 20E. Classified as Kit, Identification, Enterobacteriaceae (product code JSS), Class I - General Controls.

Submitted by Analytical Products, Inc. (Plainview, US). The FDA issued a Cleared decision on March 11, 1993 after a review of 167 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - 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 - K924814

510(k) Number K924814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1992
Decision Date March 11, 1993
Days to Decision 167 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
65d slower than avg
Panel avg: 102d · This submission: 167d
Pathway characteristics
Predicate-based equivalence.

JSS Device Classification - Class 1, General Controls

Product Code JSS Kit, Identification, Enterobacteriaceae
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JSS Kit, Identification, Enterobacteriaceae

All 32
Devices cleared under the same product code (JSS) and FDA review panel - the closest regulatory comparables to K924814.
EK/P. AERUGINOSA PNA FISH
K081433 · Advandx, Inc. · Mar 2009
E.COLI/P. AERUGINOSA PNA FISH
K081309 · Advandx, Inc. · Dec 2008
ALAMAR BACTERIAL IDENTIFICATION TEST PANEL
K926002 · Alamar Biosciences Laboratory, Inc. · Sep 1993
CRYSTAL RAPID STOOL/ENTERIC ID SYSTEM
K926017 · Becton Dickinson Microbiology Systems · Mar 1993
CRYSTAL ENTERIC/NONFERMENTER ID SYSTEM
K926018 · Becton Dickinson Microbiology Systems · Mar 1993
ROCHE ENTEROTUBE II
K922588 · Roche Diagnostic Systems, Inc. · Sep 1992