Cleared Traditional

K914225 - ACA BETA-2-MICROGLOBULIN CALIBRATOR

K914225 is the FDA 510(k) clearance for ACA BETA-2-MICROGLOBULIN CALIBRATOR by E.I. Dupont DE Nemours & Co., Inc.. It is a Class 2 Immunology device (product code JZG) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K914225 · E.I. Dupont DE Nemours & Co., Inc. · Immunology device
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Nov 1991
Decision
63d
Days
Class 2
Risk

K914225 is an FDA 510(k) clearance for the ACA(R) BETA-2-MICROGLOBULIN CALIBRATOR. Classified as System, Test, Beta-2-microglobulin Immunological (product code JZG), Class II - Special Controls.

Submitted by E.I. Dupont DE Nemours & Co., Inc. (Wilmington, US). The FDA issued a Cleared decision on November 22, 1991 after a review of 63 days - a notably fast clearance 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: 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 E.I. Dupont DE Nemours & Co., Inc. devices

Submission Details

510(k) Number K914225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1991
Decision Date November 22, 1991
Days to Decision 63 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
41d faster than avg
Panel avg: 104d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 41
Devices cleared under the same product code (JZG) and FDA review panel - the closest regulatory comparables to K914225.
COULTER BETA-2 MICROGLOBULIN IMMUNOASSAY
K923421 · Coulter Corp. · Sep 1992
SYN ELISA BETA 2 MICROGLOBULIN TEST KIT
K920132 · Elias U.S.A., Inc. · May 1992
DSL ACTIVE BETA2-MICROGLOBULIN (DSL 6500)
K915508 · Diagnostic Systems Laboratories, Inc. · Mar 1992
HUMAN BETA-2 MICROGLOBIN EN-RID KIT
K913131 · The Binding Site, Ltd. · Nov 1991
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