Cleared Traditional

K831672 - SPECTRUM-10

K831672 is the FDA 510(k) clearance for SPECTRUM-10 by Austin Biological Laboratories. It is a Class 1 Microbiology device (product code JSS) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K831672 · Austin Biological Laboratories · Microbiology device
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Jun 1983
Decision
30d
Days
Class 1
Risk

K831672 is an FDA 510(k) clearance for the SPECTRUM-10. Classified as Kit, Identification, Enterobacteriaceae (product code JSS), Class I - General Controls.

Submitted by Austin Biological Laboratories (Mchenry, US). The FDA issued a Cleared decision on June 22, 1983 after a review of 30 days - a notably fast clearance 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: 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 Austin Biological Laboratories devices

Submission Details

510(k) Number K831672 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1983
Decision Date June 22, 1983
Days to Decision 30 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 102d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 23
Devices cleared under the same product code (JSS) and FDA review panel - the closest regulatory comparables to K831672.
COBAS BACT ID TEST SYS, INDOLE SPOT TEST REAGENT
K853009 · Roche Diagnostic Systems, Inc. · Mar 1986
RIM-UREA
K843571 · Austin Biological Laboratories · Oct 1984
TITERTEK ENTEROBAC*
K834090 · Flow Laboratories, Inc. · Jan 1984
QUANTUM II BACTERIAL IDENT. SYSTEM
K830698 · Abbott Laboratories · Apr 1983
UREA-PDA DISK
K830396 · Remel Co. · Mar 1983
SYSTEK #1 EIKEN
K813164 · Syn-Kit, Inc. · Dec 1981