Cleared Special

K001891 - MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C

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

K001891 · Bio/Data Corp. · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K001891

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.

GKP Device Classification - Class 2, Special Controls

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 48
Devices cleared under the same product code (GKP) and FDA review panel - the closest regulatory comparables to K001891.
FISHER DIAGNOSTICS THROMBOSCREEN 1000
K023362 · Fisher Diagnostics · Dec 2002
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
K001891 · MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C
Download PDF FDA Summary Bio/Data Corp.