Cleared Traditional

K934053 - QUANTA LITE(TM) HISTONE ELISA

K934053 is the FDA 510(k) clearance for QUANTA LITE(TM) HISTONE ELISA by Inova Diagnostics, Inc.. It is a Class 2 Immunology device (product code LLL) cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K934053 · Inova Diagnostics, Inc. · Immunology device
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Dec 1993
Decision
124d
Days
Class 2
Risk

K934053 is an FDA 510(k) clearance for the QUANTA LITE(TM) HISTONE ELISA. 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 December 21, 1993 after a review of 124 days - within the typical 510(k) review window.

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 Inova Diagnostics, Inc. devices

Submission Details

510(k) Number K934053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1993
Decision Date December 21, 1993
Days to Decision 124 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
20d slower than avg
Panel avg: 104d · This submission: 124d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 116
Devices cleared under the same product code (LLL) and FDA review panel - the closest regulatory comparables to K934053.
ELIAS ENA SCREEN (MICROTITER PLATE)
K940622 · Elias U.S.A., Inc. · May 1994
HEMAGEN ENA SCREEN-6 KIT (EIA METHOD)
K935828 · Hemagen Diagnostics, Inc. · Apr 1994
RELISA ENA ANTIBODY SCREENING TEST SYSTEM
K935129 · Immuno Concepts, Inc. · Jan 1994
SYNELISA JO-1 ANTIBODIES
K930281 · Elias U.S.A., Inc. · Apr 1993
SYNELISA SCL-70 ANTIBODIES
K930417 · Elias U.S.A., Inc. · Apr 1993
QUANTA LITE(TM) JO-1 ELISA KIT
K926562 · Inova Diagnostics, Inc. · Mar 1993