Cleared Traditional

K910230 - LYME-SPOT IF KIT

K910230 is the FDA 510(k) clearance for LYME-SPOT IF KIT by Vitek Systems, Inc.. It is a Class 2 Microbiology device (product code LSR) cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K910230 · Vitek Systems, Inc. · Microbiology device
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Aug 1991
Decision
224d
Days
Class 2
Risk

K910230 is an FDA 510(k) clearance for the LYME-SPOT IF KIT. Classified as Reagent, Borrelia Serological Reagent (product code LSR), Class II - Special Controls.

Submitted by Vitek Systems, Inc. (Hazelwood, US). The FDA issued a Cleared decision on August 30, 1991 after a review of 224 days - an extended review 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: 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 Vitek Systems, Inc. devices

Submission Details

510(k) Number K910230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1991
Decision Date August 30, 1991
Days to Decision 224 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
122d slower than avg
Panel avg: 102d · This submission: 224d
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 54
Devices cleared under the same product code (LSR) and FDA review panel - the closest regulatory comparables to K910230.
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BARTELS LYME DISEASE IGM EIA
K922578 · Baxter Diagnostics, Inc. · Sep 1992
LYME DISEASE IGM ELISA
K900206 · Hillcrest Biologicals · Jun 1991
LYME IGM ELISA TEST
K903013 · Gull Laboratories, Inc. · Jun 1991
LYME DISEASE MICROASSAY
K910899 · Diamedix Corp. · Jun 1991