Cleared Traditional

K904254 - NA ALPHA 1 MICROGLOBULIN KIT

K904254 is an FDA 510(k) clearance for NA ALPHA 1 MICROGLOBULIN KIT, manufactured by Behring Diagnostics, Inc.. The device is a Class 2 Immunology device with product code JZG cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K904254 · Behring Diagnostics, Inc. · Immunology device
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Apr 1991
Decision
203d
Days
Class 2
Risk

K904254 is an FDA 510(k) clearance for the NA ALPHA 1 MICROGLOBULIN KIT. Classified as System, Test, Beta-2-microglobulin Immunological (product code JZG), Class II - Special Controls.

Submitted by Behring Diagnostics, Inc. (Somerville, US). The FDA issued a Cleared decision on April 5, 1991 after a review of 203 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5630 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Behring Diagnostics, Inc. devices

FDA 510(k) Submission Details - K904254

510(k) Number K904254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1990
Decision Date April 05, 1991
Days to Decision 203 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d slower than avg
Panel avg: 105d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JZG Device Classification - Class 2, Special Controls

Product Code JZG System, Test, Beta-2-microglobulin Immunological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5630
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 - JZG System, Test, Beta-2-microglobulin Immunological

All 46
Devices cleared under the same product code (JZG) and FDA review panel - the closest regulatory comparables to K904254.
DSL BETA 2 MICROGLOBULIN (DSL 6200)
K911881 · Diagnostic Systems Laboratories, Inc. · Sep 1991
DSL BETA 2 MICROGLOBULIN (DSL 6100)
K912173 · Diagnostic Systems Laboratories, Inc. · Aug 1991
COAT-A-COUNT BETA-2 MICROGLOBULIN IRMA
K912940 · Diagnostic Products Corp. · Jul 1991
MILENIA BETA-2 MICROGLOBULIN
K910052 · Diagnostic Products Corp. · Mar 1991
PHARMACIA DELFIA SYSTEM B2-MICRO
K903578 · Pharmacia, Inc. · Aug 1990
AIA-PACK BMG
K900440 · Tosoh Medics, Inc. · Feb 1990