Cleared Traditional

K870831 - PDA699/PDA700 PROTAMINE DOSE ASSAY FOR ...

K870831 is the FDA 510(k) clearance for PDA699/PDA700 PROTAMINE DOSE ASSAY FOR ... by International Technidyne Corp.. It is a Class 2 Hematology device (product code JPA) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K870831 · International Technidyne Corp. · Hematology device
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Jun 1987
Decision
90d
Days
Class 2
Risk

K870831 is an FDA 510(k) clearance for the PDA699/PDA700 PROTAMINE DOSE ASSAY FOR HEP. NEUTRA. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by International Technidyne Corp. (Edison, US). The FDA issued a Cleared decision on June 1, 1987 after a review of 90 days - within the typical 510(k) review window.

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 International Technidyne Corp. devices

Submission Details

510(k) Number K870831 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1987
Decision Date June 01, 1987
Days to Decision 90 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 113d · This submission: 90d
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 85
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K870831.
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K883484 · Helena Laboratories · Aug 1988
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K881367 · Instrumentation Laboratory CO · Jun 1988
CHROM-TROL
K872377 · Helena Laboratories · Jul 1987
COAG-A-MATE(R) XC
K870960 · Organon Teknika Corp. · Mar 1987
IL TEST 84673-30 CHROMOGENICS CONTROL PLASMA
K864271 · Instrumentation Laboratory CO · Nov 1986
KOAGULAB* M COAGULATION SYSTEM
K862537 · Ortho Diagnostic Systems, Inc. · Jul 1986