Cleared Traditional

K900726 - MICROTEK MEDICAL'S BLOOD COLLECTION KIT

K900726 is an FDA 510(k) clearance for MICROTEK MEDICAL'S BLOOD COLLECTION KIT, manufactured by Microbio-Medics, Inc.. The device is a Class 2 Chemistry device with product code JKA cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K900726 · Microbio-Medics, Inc. · Chemistry device
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May 1990
Decision
78d
Days
Class 2
Risk

K900726 is an FDA 510(k) clearance for the MICROTEK MEDICAL'S BLOOD COLLECTION KIT. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Microbio-Medics, Inc. (Columbus, US). The FDA issued a Cleared decision on May 4, 1990 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1675 - the FDA in vitro diagnostics and chemistry 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 Microbio-Medics, Inc. devices

FDA 510(k) Submission Details - K900726

510(k) Number K900726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1990
Decision Date May 04, 1990
Days to Decision 78 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 88d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JKA Device Classification - Class 2, Special Controls

Product Code JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1675
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

All 120
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K900726.
QBC E-Z PREP
K913399 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1991
SUPERSERUM REAGENT (SSR)
K910646 · International Technidyne Corp. · May 1991
VACUTAINER PLUS WITH HEMOGARD CLOSURE
K901449 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1990
VENOJECT II BLOOD COLLECTION TUBES
K900309 · Terumo Medical Corp. · Mar 1990
PUMPETTE(TM)
K884111 · Helena Laboratories · Dec 1988
CIBA CORNING BLOOD COLLECTION CAPILLARY TUBE
K883813 · Ciba Corning Diagnostics Corp. · Nov 1988