Cleared Traditional

K872377 - CHROM-TROL

K872377 is the FDA 510(k) clearance for CHROM-TROL by Helena Laboratories. It is a Class 2 Hematology device (product code JPA) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K872377 · Helena Laboratories · Hematology device
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Jul 1987
Decision
20d
Days
Class 2
Risk

K872377 is an FDA 510(k) clearance for the CHROM-TROL. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on July 9, 1987 after a review of 20 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 Helena Laboratories devices

Submission Details

510(k) Number K872377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1987
Decision Date July 09, 1987
Days to Decision 20 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
93d faster than avg
Panel avg: 113d · This submission: 20d
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 K872377.
KD ONE-STAGE PROTHROMBIN TIME TEST
K883640 · King Diagnostics, Inc. · Oct 1988
OWREN'S VERONAL BUFFER
K883484 · Helena Laboratories · Aug 1988
ACL SYSTEMS 100, 200, 300 AND 300+ COAGULATION SYS
K881367 · Instrumentation Laboratory CO · Jun 1988
PDA699/PDA700 PROTAMINE DOSE ASSAY FOR HEP. NEUTRA
K870831 · International Technidyne Corp. · Jun 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