Cleared Traditional

K952309 - N LATEX IGA

K952309 is the FDA 510(k) clearance for N LATEX IGA by Behring Diagnostics, Inc.. It is a Class 2 Immunology device (product code CZP) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K952309 · Behring Diagnostics, Inc. · Immunology device
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Jun 1995
Decision
34d
Days
Class 2
Risk

K952309 is an FDA 510(k) clearance for the N LATEX IGA. Classified as Iga, Antigen, Antiserum, Control (product code CZP), Class II - Special Controls.

Submitted by Behring Diagnostics, Inc. (Westwood, US). The FDA issued a Cleared decision on June 20, 1995 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - 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 K952309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1995
Decision Date June 20, 1995
Days to Decision 34 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 104d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CZP Iga, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
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 - CZP Iga, Antigen, Antiserum, Control

All 42
Devices cleared under the same product code (CZP) and FDA review panel - the closest regulatory comparables to K952309.
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IGA SUBCLASS RID KIT FOR DIAGNOSTIC USE
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IL TEST IMMUNOGLOBULIN A
K920014 · Instrumentation Laboratory CO · Jun 1992
TITAN GEL IMMUNOFIX KIT, CAT. NO. 3046
K900422 · Helena Laboratories · Feb 1990