Cleared Traditional

K902083 - CHROM-TROL CAT. NO. 5300 W/ NEW ANALYTE

K902083 is the FDA 510(k) clearance for CHROM-TROL CAT. NO. 5300 W/ NEW ANALYTE by Helena Laboratories. It is a Class 2 Hematology device (product code GJT) cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K902083 · Helena Laboratories · Hematology device
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Jun 1990
Decision
39d
Days
Class 2
Risk

K902083 is an FDA 510(k) clearance for the CHROM-TROL CAT. NO. 5300 W/ NEW ANALYTE. Classified as Plasma, Coagulation Factor Deficient (product code GJT), Class II - Special Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on June 15, 1990 after a review of 39 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7290 - 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 K902083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1990
Decision Date June 15, 1990
Days to Decision 39 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
74d faster than avg
Panel avg: 113d · This submission: 39d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GJT Plasma, Coagulation Factor Deficient
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7290
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 - GJT Plasma, Coagulation Factor Deficient

All 60
Devices cleared under the same product code (GJT) and FDA review panel - the closest regulatory comparables to K902083.
CLOTTING FACTOR V DEFICIENT PLASMA
K924394 · Behring Diagnostics, Inc. · Dec 1992
DADE IMMUNOADSORBED FACTOR IX DEFICIENT PLASMA
K915411 · Baxter Diagnostics, Inc. · May 1992
DADE(R) IMMUNOADSORBED FACT V DEF PLASMA (HUMAN)
K912679 · Baxter Healthcare Corp · Sep 1991
ORTHO CORRECTION REAGENTS
K901327 · Ortho Diagnostic Systems, Inc. · May 1990
FACTOR V DEFICIENT PLASMA
K900406 · Sigma Chemical Co. · Mar 1990
FACTOR VII DEFICIENT PLASMA
K900407 · Sigma Chemical Co. · Mar 1990