Cleared Traditional

K990566 - TAS ANALYZER

K990566 is the FDA 510(k) clearance for TAS ANALYZER by Cardiovascular Diagnostics, Inc.. It is a Class 2 Hematology device (product code JPA) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K990566 · Cardiovascular Diagnostics, Inc. · Hematology device
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Optimized for regulatory review, auditing and printing
May 1999
Decision
81d
Days
Class 2
Risk

K990566 is an FDA 510(k) clearance for the TAS ANALYZER, MODEL 1009. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Cardiovascular Diagnostics, Inc. (Raleigh, US). The FDA issued a Cleared decision on May 14, 1999 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - the FDA hematology 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 Cardiovascular Diagnostics, Inc. devices

Submission Details

510(k) Number K990566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1999
Decision Date May 14, 1999
Days to Decision 81 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 113d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JPA System, Multipurpose For In Vitro Coagulation Studies
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
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 - JPA System, Multipurpose For In Vitro Coagulation Studies

All 117
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K990566.
ACL 9000 SYSTEM
K000053 · Instrumentation Laboratory CO · Mar 2000
BEHRING COAGULATION SYSTEM (BCS)
K992959 · Dade Behring, Inc. · Jan 2000
DADE BEHRING BFTII
K984501 · Dade Behring, Inc. · Jul 1999
HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE
K990449 · International Technidyne Corp. · Apr 1999
STAR AUTOMATED MULTI-PARAMETRIC ANALYZER
K983460 · American Bioproducts Co. · Nov 1998
SYSMEX AUTOMATED COAGULATION ANALYZER CA-500
K981711 · Dade Behring, Inc. · Sep 1998