Cleared Traditional

K000535 - QUANTA LITE LKM-1 ELISA

K000535 is an FDA 510(k) clearance for QUANTA LITE LKM-1 ELISA, manufactured by Inova Diagnostics, Inc.. The device is a Class 2 Immunology device with product code NBS cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K000535 · Inova Diagnostics, Inc. · Immunology device
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Jun 2000
Decision
111d
Days
Class 2
Risk

K000535 is an FDA 510(k) clearance for the QUANTA LITE LKM-1 ELISA. Classified as Autoantibodies, Lkm-1 (liver/kidney Microsome, Type 1) (product code NBS), Class II - Special Controls.

Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on June 7, 2000 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5660 - 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

FDA 510(k) Submission Details - K000535

510(k) Number K000535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2000
Decision Date June 07, 2000
Days to Decision 111 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
6d slower than avg
Panel avg: 105d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NBS Device Classification - Class 2, Special Controls

Product Code NBS Autoantibodies, Lkm-1 (liver/kidney Microsome, Type 1)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5660
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.