Cleared Traditional

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

K870831 is an FDA 510(k) clearance for PDA699/PDA700 PROTAMINE DOSE ASSAY FOR ..., manufactured by International Technidyne Corp.. The device is a Class 2 Hematology device with 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

FDA 510(k) Submission Details - K870831

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
Combination Product No
PCCP Authorized No
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.

JPA Device Classification - Class 2, Special Controls

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 145
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K870831.
ACL SYSTEMS 100, 200, 300 AND 300+ COAGULATION SYS
K881367 · Instrumentation Laboratory CO · Jun 1988
CLP 0.1 M SODIUM CITRATE SOLUTION
K880713 · Creative Laboratory Products, Inc. · Mar 1988
CHROM-TROL
K872377 · Helena Laboratories · Jul 1987
COAGULATION CONTROL, LEVEL I
K870685 · U. S. Diagnostics, Inc. · Apr 1987
COAGULATION CONTROL, LEVEL II
K870686 · U. S. Diagnostics, Inc. · Apr 1987
COAGULATION CONTROL, LEVEL III
K870687 · U. S. Diagnostics, Inc. · Apr 1987