Cleared Traditional

K926562 - QUANTA LITE(TM) JO-1 ELISA KIT

K926562 is an FDA 510(k) clearance for QUANTA LITE(TM) JO-1 ELISA KIT, manufactured by Inova Diagnostics, Inc.. The device is a Class 2 Immunology device with product code LLL cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K926562 · Inova Diagnostics, Inc. · Immunology device
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Mar 1993
Decision
63d
Days
Class 2
Risk

K926562 is an FDA 510(k) clearance for the QUANTA LITE(TM) JO-1 ELISA KIT. Classified as Extractable Antinuclear Antibody, Antigen And Control (product code LLL), Class II - Special Controls.

Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on March 4, 1993 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5100 - 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: 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 Inova Diagnostics, Inc. devices

FDA 510(k) Submission Details - K926562

510(k) Number K926562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 1992
Decision Date March 04, 1993
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
42d faster than avg
Panel avg: 105d · This submission: 63d
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 146
Devices cleared under the same product code (LLL) and FDA review panel - the closest regulatory comparables to K926562.
DIASTAT ANTI-CENTROMERE KIT
K932877 · Shield Diagnostics, Ltd. · Oct 1993
SYNELISA JO-1 ANTIBODIES
K930281 · Elias U.S.A., Inc. · Apr 1993
SYNELISA SCL-70 ANTIBODIES
K930417 · Elias U.S.A., Inc. · Apr 1993
EN TYPING CIE KIT FOR DIAGNOSTIC USE
K925118 · The Binding Site, Ltd. · Feb 1993
ENA SCREENING CIE KIT FOR DIAGNOSTIC USE
K924262 · The Binding Site, Ltd. · Dec 1992
QUANTA LITE(TM) SCL-70 ELISA
K924898 · Inova Diagnostics, Inc. · Dec 1992