Cleared Traditional

K984222 - QUANTA LITE LYME IGG ELISA

K984222 is an FDA 510(k) clearance for QUANTA LITE LYME IGG ELISA, manufactured by Inova Diagnostics, Inc.. The device is a Class 2 Microbiology device with product code LSR cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K984222 · Inova Diagnostics, Inc. · Microbiology device
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Apr 1999
Decision
141d
Days
Class 2
Risk

K984222 is an FDA 510(k) clearance for the QUANTA LITE LYME IGG 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

FDA 510(k) Submission Details - K984222

510(k) Number K984222 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.

LSR Device Classification - Class 2, Special Controls

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 97
Devices cleared under the same product code (LSR) and FDA review panel - the closest regulatory comparables to K984222.
QUALICODE B. BURGDORFERI IGG WESTERN BLOT KIT, MODEL DK-C052-024
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K991180 · Zeus Scientific, Inc. · Sep 1999
BORRELIA BURGDORFERI IGM WESTERN BLOT TEST SYSTEM
K991185 · Zeus Scientific, Inc. · Sep 1999
QUANTA LITE LYME IGM ELISA
K984234 · Inova Diagnostics, Inc. · Apr 1999
APTUS (AUTOMATED) APPLICATION FOR THE B. BURGDORFERI ANTIBODY ELISA TEST SYSTEM
K984138 · Zeus Scientific, Inc. · Mar 1999
BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERN BLOT KIT
K980351 · Boston Biomedica, Inc. · Mar 1999