Cleared Traditional

K820126 - RAPID BACTERIURIA SCREENING TEST

K820126 is the FDA 510(k) clearance for RAPID BACTERIURIA SCREENING TEST by Analytical Luminescence Laboratory, Inc.. It is a Class 1 Microbiology device (product code JXA) cleared through the Traditional 510(k) pathway after a 354-day FDA review.

K820126 · Analytical Luminescence Laboratory, Inc. · Microbiology device
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Jan 1983
Decision
354d
Days
Class 1
Risk

K820126 is an FDA 510(k) clearance for the RAPID BACTERIURIA SCREENING TEST. Classified as Kit, Screening, Urine (product code JXA), Class I - General Controls.

Submitted by Analytical Luminescence Laboratory, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 7, 1983 after a review of 354 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. Elevated predicate reliance profile. 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 Luminescence Laboratory, Inc. devices

Submission Details

510(k) Number K820126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1982
Decision Date January 07, 1983
Days to Decision 354 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
252d slower than avg
Panel avg: 102d · This submission: 354d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JXA Kit, Screening, Urine
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 - JXA Kit, Screening, Urine

All 11
Devices cleared under the same product code (JXA) and FDA review panel - the closest regulatory comparables to K820126.
ORTHO BACTERIURIA DETECTION SYS
K833834 · Ortho Diagnostic Systems, Inc. · Mar 1984
DIPCHEX DIP-SLIDE CULTURE SYS
K830252 · Granite Diagnostics, Inc. · Mar 1983
BAC-T-SCREEN BACTERIURIA DETECTION DEV
K823850 · Marion Laboratories, Inc. · Mar 1983
MS-2 AUTOMATED URINE SCREENING SYSTEM
K781370 · Abbott Laboratories · Sep 1978
VAC-U-PAC KIDNEY CASSETTE
K781536 · E-Z-Em, Inc. · Sep 1978
MICROCULT-ID
K771672 · Miles Laboratories, Inc. · Dec 1977