Cleared Traditional

K832225 - ORTHO ABNORMAL COAGULATION LEVEL I/II

K832225 is the FDA 510(k) clearance for ORTHO ABNORMAL COAGULATION LEVEL I/II by Ortho Diagnostic Systems, Inc.. It is a Class 2 Hematology device (product code JPA) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K832225 · Ortho Diagnostic Systems, Inc. · Hematology device
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Aug 1983
Decision
35d
Days
Class 2
Risk

K832225 is an FDA 510(k) clearance for the ORTHO ABNORMAL COAGULATION LEVEL I/II. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Ortho Diagnostic Systems, Inc. (Carpinteria, US). The FDA issued a Cleared decision on August 12, 1983 after a review of 35 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 Ortho Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K832225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1983
Decision Date August 12, 1983
Days to Decision 35 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
78d faster than avg
Panel avg: 113d · This submission: 35d
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 116
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K832225.
GEN. DIAG. CHROMOSTRATE REF. PLASMA
K850409 · Warner-Lambert Co. · May 1985
COBAS-FIBRO
K842717 · Roche Diagnostic Systems, Inc. · Oct 1984
THROMBOPLASTIN - FS
K833272 · American Dade · Nov 1983
DIGICLOT 2-#820
K812121 · Volu Sol Medical Industries · Nov 1981
MULTI CLOT-#819
K812122 · Volu Sol Medical Industries · Nov 1981
NORM-TROL
K792310 · Helena Laboratories · Dec 1979