Cleared Traditional

K984234 - QUANTA LITE LYME IGM ELISA

K984234 is the FDA 510(k) clearance for QUANTA LITE LYME IGM ELISA by Inova Diagnostics, Inc.. It is a Class 2 Microbiology device (product code LSR) cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K984234 · Inova Diagnostics, Inc. · Microbiology device
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Apr 1999
Decision
141d
Days
Class 2
Risk

K984234 is an FDA 510(k) clearance for the QUANTA LITE LYME IGM ELISA. Classified as Reagent, Borrelia Serological Reagent (product code LSR), Class II - Special Controls.

Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on April 15, 1999 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3830 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Inova Diagnostics, Inc. devices

Submission Details

510(k) Number K984234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1998
Decision Date April 15, 1999
Days to Decision 141 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 102d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LSR Reagent, Borrelia Serological Reagent
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3830
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 Microbiology devices follow this clearance model.

Regulatory Peers - LSR Reagent, Borrelia Serological Reagent

All 50
Devices cleared under the same product code (LSR) and FDA review panel - the closest regulatory comparables to K984234.
BORRELIA BURGDORFERI IGG WESTERN BLOT TEST SYSTEM
K991180 · Zeus Scientific, Inc. · Sep 1999
BORRELIA BURGDORFERI IGM WESTERN BLOT TEST SYSTEM
K991185 · Zeus Scientific, Inc. · Sep 1999
QUANTA LITE LYME IGG ELISA
K984222 · Inova Diagnostics, Inc. · Apr 1999
APTUS (AUTOMATED) APPLICATION FOR THE B. BURGDORFERI ANTIBODY ELISA TEST SYSTEM
K984138 · Zeus Scientific, Inc. · Mar 1999
VIDAS LYME SCREEN II
K943812 · Biomerieux Vitek, Inc. · Jun 1995
BARTELS LYME DISEASE IGM EIA
K922578 · Baxter Diagnostics, Inc. · Sep 1992