Cleared Traditional

K890634 - BERICHROM PROTEIN C KIT

K890634 is the FDA 510(k) clearance for BERICHROM PROTEIN C KIT by Behring Diagnostics, Inc.. It is a Class 2 Hematology device (product code GGP) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K890634 · Behring Diagnostics, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1989
Decision
72d
Days
Class 2
Risk

K890634 is an FDA 510(k) clearance for the BERICHROM PROTEIN C KIT. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by Behring Diagnostics, Inc. (Somerville, US). The FDA issued a Cleared decision on April 21, 1989 after a review of 72 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 Behring Diagnostics, Inc. devices

Submission Details

510(k) Number K890634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1989
Decision Date April 21, 1989
Days to Decision 72 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
41d faster than avg
Panel avg: 113d · This submission: 72d
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 K890634.
PROTEIN C ANTIGEN ROCKET EID METHOD NO. 5357
K897136 · Helena Laboratories · Feb 1990
THE STAGO VIII DEFICIENT PLASMA KIT
K892859 · American Bioproducts Co. · Jun 1989
BERICHROM ALPHA-2-ANTIPLASMIN
K884797 · Behring Diagnostics, Inc. · Apr 1989
RELLPLATE C KIT, RELLPLATE C BULK PLATES
K884940 · American Diagnostic Corp. · Mar 1989
ACTICLOT C KIT
K884941 · American Diagnostic Corp. · Mar 1989
DADE(R) PLASMINOGEN CHROMOGENIC ASSAY
K890409 · Baxter Healthcare Corp · Feb 1989