Cleared Traditional

SEPTI-CHEK SCHAEDLER MED. BLOOD CULTURE BOTTLE-ROC (K851249) - FDA 510(k) Clearance

Class I Microbiology device.

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 306
Devices cleared under the same product code (JSJ) and FDA review panel - the closest regulatory comparables to K851249.
GBNA MEDIUM
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K871702 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1987
MCBRIDE AGAR, MODIFIED
K871357 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1987
REGAN-LOWE CHARCOAL AGAR
K863524 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1986
YEP (YEAST EXTRACT PHOSPHATE) AGAR
K863526 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1986
BACTEC 13A MEDIUM (7H13)
K863191 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1986