Cleared Traditional

K851249 - SEPTI-CHEK SCHAEDLER MED. BLOOD CULTURE...

K851249 is the FDA 510(k) clearance for SEPTI-CHEK SCHAEDLER MED. BLOOD CULTURE... by Roche Diagnostic Systems, Inc.. It is a Class 1 Microbiology device (product code JSJ) cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K851249 · Roche Diagnostic Systems, Inc. · Microbiology device
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Apr 1985
Decision
26d
Days
Class 1
Risk

K851249 is an FDA 510(k) clearance for the SEPTI-CHEK SCHAEDLER MED. BLOOD CULTURE BOTTLE-ROC. Classified as Culture Media, Selective And Non-differential (product code JSJ), Class I - General Controls.

Submitted by Roche Diagnostic Systems, Inc. (Nutley, US). The FDA issued a Cleared decision on April 22, 1985 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2360 - 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 Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K851249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1985
Decision Date April 22, 1985
Days to Decision 26 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
76d faster than avg
Panel avg: 102d · This submission: 26d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSJ Culture Media, Selective And Non-differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2360
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 - JSJ Culture Media, Selective And Non-differential

All 229
Devices cleared under the same product code (JSJ) and FDA review panel - the closest regulatory comparables to K851249.
BIOTIS ANAEROBIC CNA
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K860416 · Otisville Biotech, Inc. · Feb 1986
BLOOD AGAR W/AMPICILLIN, BAP W/AMPICILLIN
K853335 · Hardy Media · Aug 1985
KANAMYCIN-VANCOMYCIN-LAKED BLOOD AGAR
K851347 · Micro Media Laboratories · Apr 1985
COBA AGAR
K851348 · Micro Media Laboratories · Apr 1985
CHOCOLATE AGAR W/BACITRACIN, CHOCOLATE W/BACITRACI
K850555 · Hardy Media · Apr 1985