Cleared Traditional

LYME-CHECK(TM) TEST KIT (K896378) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K896378 · Diagnostic Technology, Inc. · Microbiology device
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Nov 1991
Decision
729d
Days
Class 2
Risk

K896378 is an FDA 510(k) clearance for the LYME-CHECK(TM) TEST KIT. Classified as Reagent, Borrelia Serological Reagent (product code LSR), Class II - Special Controls.

Submitted by Diagnostic Technology, Inc. (Hauppauge, US). The FDA issued a Cleared decision on November 5, 1991 after a review of 729 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all Diagnostic Technology, Inc. devices

Submission Details

510(k) Number K896378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1989
Decision Date November 05, 1991
Days to Decision 729 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
627d slower than avg
Panel avg: 102d · This submission: 729d
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 37
Devices cleared under the same product code (LSR) and FDA review panel - the closest regulatory comparables to K896378.
QUANTA LITE LYME IGG ELISA
K984222 · Inova Diagnostics, Inc. · Apr 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
3M IGG FASTLYME(TM) TEST
K895713 · 3M Company · Dec 1990
LYME IGM ELISA TEST SYSTEM
K900196 · Zeus Scientific, Inc. · May 1990
LYME IGG ELISA TEST SYSTEM
K895292 · Zeus Scientific, Inc. · Dec 1989