Cleared Traditional

K896174 - PROTEIN S ANTIGEN ROCKET EID KIT, CAT. NO. 5359

K896174 is an FDA 510(k) clearance for PROTEIN S ANTIGEN ROCKET EID KIT, manufactured by Helena Laboratories. The device is a Class 2 Hematology device with product code GGP cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K896174 · Helena Laboratories · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1990
Decision
141d
Days
Class 2
Risk

K896174 is an FDA 510(k) clearance for the PROTEIN S ANTIGEN ROCKET EID KIT, CAT. NO. 5359. 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 March 15, 1990 after a review of 141 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Helena Laboratories devices

FDA 510(k) Submission Details - K896174

510(k) Number K896174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1989
Decision Date March 15, 1990
Days to Decision 141 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
28d slower than avg
Panel avg: 113d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GGP Device Classification - Class 2, Special Controls

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 155
Devices cleared under the same product code (GGP) and FDA review panel - the closest regulatory comparables to K896174.
LIATEST PROTEIN S KIT
K912468 · American Bioproducts Co. · Oct 1991
DADE PROTEIN C CLOTTING ASSAY
K903468 · Baxter Healthcare Corp · Feb 1991
FREE PROTEIN S REAGENT CAT. NO. 5363
K904247 · Helena Laboratories · Jan 1991
ORTHOKROME* FACTOR VIII
K900395 · Ortho Diagnostic Systems, Inc. · Mar 1990
ORTHOKROME* ANTIPLASMIN
K900397 · Ortho Diagnostic Systems, Inc. · Mar 1990
ORTHOKROME* PROTEIN C
K900398 · Ortho Diagnostic Systems, Inc. · Mar 1990