Cleared Traditional

K910899 - LYME DISEASE MICROASSAY

K910899 is an FDA 510(k) clearance for LYME DISEASE MICROASSAY, manufactured by Diamedix Corp.. The device is a Class 2 Microbiology device with product code LSR cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K910899 · Diamedix Corp. · Microbiology device
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Jun 1991
Decision
105d
Days
Class 2
Risk

K910899 is an FDA 510(k) clearance for the LYME DISEASE MICROASSAY. Classified as Reagent, Borrelia Serological Reagent (product code LSR), Class II - Special Controls.

Submitted by Diamedix Corp. (Miami, US). The FDA issued a Cleared decision on June 10, 1991 after a review of 105 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 Diamedix Corp. devices

FDA 510(k) Submission Details - K910899

510(k) Number K910899 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1991
Decision Date June 10, 1991
Days to Decision 105 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
3d slower than avg
Panel avg: 102d · This submission: 105d
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 90
Devices cleared under the same product code (LSR) and FDA review panel - the closest regulatory comparables to K910899.
LYME-SPOT IF KIT
K910230 · Vitek Systems, Inc. · Aug 1991
LYME DISEASE IGM ELISA
K900206 · Hillcrest Biologicals · Jun 1991
LYME IGM ELISA TEST
K903013 · Gull Laboratories, Inc. · Jun 1991
LYME IGM MICROASSAY
K911330 · Diamedix Corp. · Jun 1991
BORRELIA BURGDORFERI POLYVAL IGG/IGM ANTIBODY TEST
K911145 · Medical Diagnostic Technologies, Inc. · May 1991
3M IGG FASTLYME(TM) TEST
K895713 · 3M Company · Dec 1990