Cleared Traditional

K875273 - BITEK(TM) BLOOD CULTURE SYSTEM

K875273 is the FDA 510(k) clearance for BITEK(TM) BLOOD CULTURE SYSTEM by Definitive Diagnostics, Inc.. It is a Class 1 Microbiology device (product code JSG) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K875273 · Definitive Diagnostics, Inc. · Microbiology device
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Jan 1988
Decision
29d
Days
Class 1
Risk

K875273 is an FDA 510(k) clearance for the BITEK(TM) BLOOD CULTURE SYSTEM. Classified as Culture Media, Non-selective And Non-differential (product code JSG), Class I - General Controls.

Submitted by Definitive Diagnostics, Inc. (Tualatin, US). The FDA issued a Cleared decision on January 22, 1988 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2300 - 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 Definitive Diagnostics, Inc. devices

Submission Details

510(k) Number K875273 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1987
Decision Date January 22, 1988
Days to Decision 29 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 102d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSG Culture Media, Non-selective And Non-differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2300
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 - JSG Culture Media, Non-selective And Non-differential

All 176
Devices cleared under the same product code (JSG) and FDA review panel - the closest regulatory comparables to K875273.
TSA W/LEC. & TWEEN. 80
K880142 · Hardy Media · Mar 1988
BACTEC(R) NR26 AND BACTEC(R) NR 27 CULTURE MEDIA
K881115 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1988
NUTRIENT BROTH
K880114 · Hardy Media · Mar 1988
COLUMBIA BLOOD AGAR P3308/ COLUMBIA CNA P3750
K875136 · Lakewood Biochemical Co., Inc. · Jan 1988
TODD-HEWITT BROTH (0.5ML)#3099 & (5.OML)#T3516
K874538 · Lakewood Biochemical Co., Inc. · Nov 1987
TSA 5% SHEEP BLOOD/EMB AGAR - PRODUCT #Z3023
K873480 · Lakewood Biochemical Co., Inc. · Oct 1987