Cleared Traditional

K890843 - LYME DISEASE MICROASSAY

K890843 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 154-day FDA review.

K890843 · Diamedix Corp. · Microbiology device
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Jul 1989
Decision
154d
Days
Class 2
Risk

K890843 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 July 25, 1989 after a review of 154 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 Diamedix Corp. devices

FDA 510(k) Submission Details - K890843

510(k) Number K890843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1989
Decision Date July 25, 1989
Days to Decision 154 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
52d slower than avg
Panel avg: 102d · This submission: 154d
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 K890843.
LYME IGM MICROASSAY
K900572 · Diamedix Corp. · May 1990
LYME IGG ELISA TEST SYSTEM
K895292 · Zeus Scientific, Inc. · Dec 1989
IMMUNODOT LYME TEST
K894410 · General Biometrics, Inc. · Oct 1989
BORRELIA BURGDORFERI POLYVALENT IGG/IGM ANTIBODY
K885290 · Medical Diagnostic Technologies, Inc. · Apr 1989
BORRELIA BURGDORFERI IGG ANTIBODY TEST SYSTEM
K885293 · Medical Diagnostic Technologies, Inc. · Apr 1989
BORRELIA BURGDORFERI IGM ANTIBODY TEST SYSTEM
K885294 · Medical Diagnostic Technologies, Inc. · Apr 1989