Cleared Special

MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C (K001891) - FDA 510(k) Clearance

Class II Hematology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K001891 · Bio/Data Corp. · Hematology device
Download Printable Device Report (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.

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
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 48
Devices cleared under the same product code (GKP) and FDA review panel - the closest regulatory comparables to K001891.
ACL TOP Family 50 Series (ACL TOP 750
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ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS)
K160276 · Instrumentation Laboratory CO · Mar 2016
ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS
K150877 · Instrumentation Laboratory CO · Dec 2015
ACL TOP 700 LAS
K091980 · Instrumentation Laboratory CO · Sep 2009
ACL TOP (WITH SYSTEM SOFTWARE V3.0.0)
K073377 · Instrumentation Laboratory CO · May 2008