Cleared Traditional

K820126 - RAPID BACTERIURIA SCREENING TEST

K820126 is an FDA 510(k) clearance for RAPID BACTERIURIA SCREENING TEST, manufactured by Analytical Luminescence Laboratory, Inc.. The device is a Class 1 Microbiology device with 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

FDA 510(k) Submission Details - K820126

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.

JXA Device Classification - Class 1, General Controls

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 13
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