Cleared Traditional

K823850 - BAC-T-SCREEN BACTERIURIA DETECTION DEV (FDA 510(k) Clearance)

Class I Microbiology device.

K823850 · Marion Laboratories, Inc. · Microbiology device
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Mar 1983
Decision
70d
Days
Class 1
Risk

K823850 is an FDA 510(k) clearance for the BAC-T-SCREEN BACTERIURIA DETECTION DEV. Classified as Kit, Screening, Urine (product code JXA), Class I - General Controls.

Submitted by Marion Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on March 1, 1983 after a review of 70 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 Marion Laboratories, Inc. devices

Submission Details

510(k) Number K823850 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1982
Decision Date March 01, 1983
Days to Decision 70 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 102d · This submission: 70d
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.