Cleared Traditional

K952594 - N PROTEIN STANDARD SY

K952594 is the FDA 510(k) clearance for N PROTEIN STANDARD SY by Behring Diagnostics, Inc.. It is a Class 2 Immunology device (product code CZW) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K952594 · Behring Diagnostics, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1995
Decision
41d
Days
Class 2
Risk

K952594 is an FDA 510(k) clearance for the N PROTEIN STANDARD SY. Classified as Complement C3, Antigen, Antiserum, Control (product code CZW), Class II - Special Controls.

Submitted by Behring Diagnostics, Inc. (Westwood, US). The FDA issued a Cleared decision on July 17, 1995 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5240 - the FDA immunology 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 K952594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1995
Decision Date July 17, 1995
Days to Decision 41 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 104d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CZW Complement C3, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5240
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 Immunology devices follow this clearance model.

Regulatory Peers - CZW Complement C3, Antigen, Antiserum, Control

All 32
Devices cleared under the same product code (CZW) and FDA review panel - the closest regulatory comparables to K952594.
OLYMPUS C3 IMMUNOTURBIDIMETRIC REGENT
K962409 · Olympus America, Inc. · Oct 1996
QUANTEX C3
K962199 · Instrumentation Laboratory CO · Sep 1996
N PROTEIN STANDARS SY
K955857 · Behring Diagnostics, Inc. · Feb 1996
IL TEST COMPLEMENT 3
K920007 · Instrumentation Laboratory CO · Jun 1992
RAICHEM SPIA C3 REAGENT
K911900 · Reagents Applications, Inc. · May 1991
C3C AND C4 RID KITS
K902382 · The Binding Site, Ltd. · Sep 1990