Cleared Traditional

K792310 - NORM-TROL

K792310 is the FDA 510(k) clearance for NORM-TROL by Helena Laboratories. It is a Class 2 Hematology device (product code JPA) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K792310 · Helena Laboratories · Hematology device
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Dec 1979
Decision
18d
Days
Class 2
Risk

K792310 is an FDA 510(k) clearance for the NORM-TROL. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Helena Laboratories (Walker, US). The FDA issued a Cleared decision on December 4, 1979 after a review of 18 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 K792310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1979
Decision Date December 04, 1979
Days to Decision 18 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
95d faster than avg
Panel avg: 113d · This submission: 18d
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 K792310.
ORTHO ABNORMAL COAGULATION LEVEL I/II
K832225 · Ortho Diagnostic Systems, Inc. · Aug 1983
DIGICLOT 2-#820
K812121 · Volu Sol Medical Industries · Nov 1981
MULTI CLOT-#819
K812122 · Volu Sol Medical Industries · Nov 1981
ELVI 818 DIGICLOT MULTISCAN
K791586 · Volu Sol Medical Industries · Sep 1979
COAG-A-MATE 2001
K790323 · General Diagnostics · Mar 1979
PLASMA, STANDARDIZED NORMAL
K790204 · Dade, Baxter Travenol Diagnostics, Inc. · Mar 1979