Cleared Traditional

K994004 - QUANTA LITE LYME B. BURGDORFERI IGG/IGM...

K994004 is the FDA 510(k) clearance for QUANTA LITE LYME B. BURGDORFERI IGG/IGM... by Inova Diagnostics, Inc.. It is a Class 2 Microbiology device (product code LSR) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K994004 · Inova Diagnostics, Inc. · Microbiology device
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Jan 2000
Decision
64d
Days
Class 2
Risk

K994004 is an FDA 510(k) clearance for the QUANTA LITE LYME B. BURGDORFERI IGG/IGM ELISA KIT. 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 January 27, 2000 after a review of 64 days - a notably fast clearance cycle.

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: 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

Submission Details

510(k) Number K994004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1999
Decision Date January 27, 2000
Days to Decision 64 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
38d faster than avg
Panel avg: 102d · This submission: 64d
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 K994004.
PLATELIA LYME IGM
K081362 · Bio-Rad · Jun 2008
PLATELIA LYME IGG ASSAY
K080012 · Bio-Rad · May 2008
LIAISON BORRELIA IGG/IGM ASSAY, MODEL 310870
K062473 · DiaSorin, Inc. · Apr 2007
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