Cleared Traditional

K897136 - PROTEIN C ANTIGEN ROCKET EID METHOD NO....

K897136 is the FDA 510(k) clearance for PROTEIN C ANTIGEN ROCKET EID METHOD NO.... by Helena Laboratories. It is a Class 2 Hematology device (product code GGP) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K897136 · Helena Laboratories · Hematology device
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Feb 1990
Decision
40d
Days
Class 2
Risk

K897136 is an FDA 510(k) clearance for the PROTEIN C ANTIGEN ROCKET EID METHOD NO. 5357. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on February 5, 1990 after a review of 40 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 K897136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1989
Decision Date February 05, 1990
Days to Decision 40 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
73d faster than avg
Panel avg: 113d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GGP Test, Qualitative And Quantitative Factor Deficiency
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 - GGP Test, Qualitative And Quantitative Factor Deficiency

All 126
Devices cleared under the same product code (GGP) and FDA review panel - the closest regulatory comparables to K897136.
ORTHOKROME* ANTIPLASMIN
K900397 · Ortho Diagnostic Systems, Inc. · Mar 1990
ORTHOKROME* PROTEIN C
K900398 · Ortho Diagnostic Systems, Inc. · Mar 1990
ORTHOKROME* PLASMINOGEN
K900399 · Ortho Diagnostic Systems, Inc. · Mar 1990
THE STAGO VIII DEFICIENT PLASMA KIT
K892859 · American Bioproducts Co. · Jun 1989
BERICHROM ALPHA-2-ANTIPLASMIN
K884797 · Behring Diagnostics, Inc. · Apr 1989
BERICHROM PROTEIN C KIT
K890634 · Behring Diagnostics, Inc. · Apr 1989