Cleared Traditional

K890843 - LYME DISEASE MICROASSAY

K890843 is the FDA 510(k) clearance for LYME DISEASE MICROASSAY by Diamedix Corp.. It is a Class 2 Microbiology device (product code LSR) cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K890843 · Diamedix Corp. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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 48
Devices cleared under the same product code (LSR) and FDA review panel - the closest regulatory comparables to K890843.
LYME IGM ELISA TEST SYSTEM
K900196 · Zeus Scientific, Inc. · May 1990
LYME IGM MICROASSAY
K900572 · Diamedix Corp. · May 1990
LYME IGG ELISA TEST SYSTEM
K895292 · Zeus Scientific, Inc. · Dec 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