Cleared Traditional

K974552 - DIAMEDIX IS-MEASLES IGG TEST SYSTEM

K974552 is the FDA 510(k) clearance for DIAMEDIX IS-MEASLES IGG TEST SYSTEM by Diamedix Corp.. It is a Class 1 Microbiology device (product code LJB) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K974552 · Diamedix Corp. · Microbiology device
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Jan 1998
Decision
55d
Days
Class 1
Risk

K974552 is an FDA 510(k) clearance for the DIAMEDIX IS-MEASLES IGG TEST SYSTEM. Classified as Enzyme Linked Immunoabsorbent Assay, Rubeola Igg (product code LJB), Class I - General Controls.

Submitted by Diamedix Corp. (Miami, US). The FDA issued a Cleared decision on January 28, 1998 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3520 - the FDA microbiology 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 Diamedix Corp. devices

Submission Details

510(k) Number K974552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1997
Decision Date January 28, 1998
Days to Decision 55 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 102d · This submission: 55d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LJB Enzyme Linked Immunoabsorbent Assay, Rubeola Igg
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3520
Definition The Qualitative Detection Of Measles Specific Igg Antibodies In Serum Or Plasma.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LJB Enzyme Linked Immunoabsorbent Assay, Rubeola Igg

Devices cleared under the same product code (LJB) and FDA review panel - the closest regulatory comparables to K974552.
QUANTA LITE RUBEOLA (MEASLES) IGG
K971620 · Inova Diagnostics, Inc. · Jul 1997
BARTELS RUBEOLA IGG EIA
K922330 · Baxter Diagnostics, Inc. · Sep 1992
BARTELS RUBEOLA IGM EIA
K922335 · Baxter Diagnostics, Inc. · Sep 1992
RUBEOLA IGM ELISA TEST
K904083 · Gull Laboratories, Inc. · Jan 1991
MEASLES IGG MICROASSAY
K903961 · Diamedix Corp. · Dec 1990
RUBEOLA IGG ELISA TEST
K904854 · Gull Laboratories, Inc. · Dec 1990