Cleared Special

K001891 - MICROSAMPLE COAGULATION ANALYZER

K001891 is the FDA 510(k) clearance for MICROSAMPLE COAGULATION ANALYZER by Bio/Data Corp.. It is a Class 2 Hematology device (product code GKP) cleared through the Special 510(k) pathway after a 21-day FDA review.

K001891 · Bio/Data Corp. · Hematology device
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Jul 2000
Decision
21d
Days
Class 2
Risk

K001891 is an FDA 510(k) clearance for the MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C. Classified as Instrument, Coagulation, Automated (product code GKP), Class II - Special Controls.

Submitted by Bio/Data Corp. (Horsham, US). The FDA issued a Cleared decision on July 12, 2000 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5400 - the FDA hematology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Bio/Data Corp. devices

Submission Details

510(k) Number K001891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2000
Decision Date July 12, 2000
Days to Decision 21 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 113d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GKP Instrument, Coagulation, Automated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5400
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 Hematology devices follow this clearance model.

Regulatory Peers - GKP Instrument, Coagulation, Automated

All 36
Devices cleared under the same product code (GKP) and FDA review panel - the closest regulatory comparables to K001891.
SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560
K031377 · Dade Behring, Inc. · Sep 2003
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000
K020979 · Dade Behring, Inc. · Jun 2002
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
K001645 · Dade Behring, Inc. · Aug 2000
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000
K001145 · Dade Behring, Inc. · May 2000
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
K993299 · Dade Behring, Inc. · Dec 1999
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000
K993174 · Dade Behring, Inc. · Nov 1999