Cleared Traditional

K911679 - ANTI-JO-1 MICROASSAY

K911679 is an FDA 510(k) clearance for ANTI-JO-1 MICROASSAY, manufactured by Diamedix Corp.. The device is a Class 2 Immunology device with product code LLL cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K911679 · Diamedix Corp. · Immunology device
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Sep 1991
Decision
161d
Days
Class 2
Risk

K911679 is an FDA 510(k) clearance for the ANTI-JO-1 MICROASSAY. Classified as Extractable Antinuclear Antibody, Antigen And Control (product code LLL), Class II - Special Controls.

Submitted by Diamedix Corp. (Miami, US). The FDA issued a Cleared decision on September 23, 1991 after a review of 161 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5100 - 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 Diamedix Corp. devices

FDA 510(k) Submission Details - K911679

510(k) Number K911679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1991
Decision Date September 23, 1991
Days to Decision 161 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
56d slower than avg
Panel avg: 105d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLL Device Classification - Class 2, Special Controls

Product Code LLL Extractable Antinuclear Antibody, Antigen And Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5100
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 - LLL Extractable Antinuclear Antibody, Antigen And Control

All 143
Devices cleared under the same product code (LLL) and FDA review panel - the closest regulatory comparables to K911679.
HEMAGEN ENA SCL-70 KIT (EIA METHOD)
K915282 · Hemagen Diagnostics, Inc. · Feb 1992
HEMAGEN ENA SCREENING KIT (EIA METHOD)
K915058 · Hemagen Diagnostics, Inc. · Dec 1991
HEMAGEN ENA (SS-A/SS-B) KIT (EIA METHOD)
K915234 · Hemagen Diagnostics, Inc. · Dec 1991
HEMAGEN ENA SCREENING KIT
K910232 · Hemagen Diagnostics, Inc. · Mar 1991
QUANTA LITE TM DSDNA
K903898 · Inova Diagnostics, Inc. · Sep 1990
ANTI-SCI-70 ANTIBODY TEST
K903314 · Immco Diagnostics, Inc. · Aug 1990