Cleared Traditional

K931149 - CA-1000 AUTOMATED COAGULATION ANALYZER

K931149 is the FDA 510(k) clearance for CA-1000 AUTOMATED COAGULATION ANALYZER by Toa Medical Electronics USA, Inc.. It is a Class 2 Hematology device (product code JPA) cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K931149 · Toa Medical Electronics USA, Inc. · Hematology device
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Nov 1993
Decision
240d
Days
Class 2
Risk

K931149 is an FDA 510(k) clearance for the CA-1000 AUTOMATED COAGULATION ANALYZER. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Toa Medical Electronics USA, Inc. (Los Alamitos, US). The FDA issued a Cleared decision on November 3, 1993 after a review of 240 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Toa Medical Electronics USA, Inc. devices

Submission Details

510(k) Number K931149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1993
Decision Date November 03, 1993
Days to Decision 240 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
127d slower than avg
Panel avg: 113d · This submission: 240d
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 K931149.
ACT CONTROL SET
K940840 · Sigma Diagnostics, Inc. · Jul 1994
JR. MICROCOAGULATION SYSTEM
K940401 · International Technidyne Corp. · May 1994
R & D BATTERIES, INC. PART NUMBERS 5296, 5479, 5351, & 5470
K934747 · R & D Batteries, Inc. · Dec 1993
DADE (PAI-1) CHROMOGENIC ASSAY DADE COAGTROL-PAI
K933188 · Baxter Diagnostics, Inc. · Sep 1993
BOEHRINGER MANNHEIM COAGUCHEK SYSTEM
K930454 · Boehringer Mannheim Corp. · Aug 1993
VERIFY REFERENCE PLASMA AND MDA VERIFY REF. PLASMA
K930849 · Organon Teknika Corp. · Apr 1993