Cleared Traditional

K926002 - ALAMAR BACTERIAL IDENTIFICATION TEST PANEL

K926002 is an FDA 510(k) clearance for ALAMAR BACTERIAL IDENTIFICATION TEST PANEL, manufactured by Alamar Biosciences Laboratory, Inc.. The device is a Class 1 Microbiology device with product code JSS cleared through the Traditional 510(k) pathway after a 300-day FDA review.

K926002 · Alamar Biosciences Laboratory, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1993
Decision
300d
Days
Class 1
Risk

K926002 is an FDA 510(k) clearance for the ALAMAR BACTERIAL IDENTIFICATION TEST PANEL. Classified as Kit, Identification, Enterobacteriaceae (product code JSS), Class I - General Controls.

Submitted by Alamar Biosciences Laboratory, Inc. (Sacramento, US). The FDA issued a Cleared decision on September 23, 1993 after a review of 300 days - an unusually long review period, suggesting complex equivalence evaluation.

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 Alamar Biosciences Laboratory, Inc. devices

FDA 510(k) Submission Details - K926002

510(k) Number K926002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1992
Decision Date September 23, 1993
Days to Decision 300 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
198d slower than avg
Panel avg: 102d · This submission: 300d
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 25
Devices cleared under the same product code (JSS) and FDA review panel - the closest regulatory comparables to K926002.
API 20E/UNISCEPT 20E
K924814 · Analytical Products, Inc. · Mar 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
SENSITITRE INDOLE REAGENT
K894776 · Radiometer America, Inc. · Aug 1989
VITEK GRAM-NEGATIVE IDENTIFICATION CARD
K883558 · Vitek Systems, Inc. · Sep 1988