Identifiers
- 510(k) Number
- K900572 FDA 510(k)
- FDA Product Code
- LSR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3830 FDA 510(k)
- Regulation Number
- 866.3830 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Lyme IgM Microassay is a reagent, Borrelia serological reagent, used in microbiology for the detection of IgM antibodies to Borrelia burgdorferi. It is classified as a Class II medical device under regulation number 866.3830 and product code LSR.
The device received FDA 510(k) clearance via traditional pathway (K900572) on May 2, 1990, and is substantially equivalent to a predicate device. It is manufactured by Diamedix Corp. and is intended for use in clinical laboratory settings as an in vitro diagnostic reagent.
Frequently asked questions
What is the Lyme IgM Microassay used for?
The Lyme IgM Microassay is a reagent used in microbiology for the detection of IgM antibodies to Borrelia burgdorferi. It is intended for use as an in vitro diagnostic reagent in clinical laboratory settings to aid in the serological assessment of Lyme disease.
How is the Lyme IgM Microassay supplied and what is its format?
The Lyme IgM Microassay is supplied as a reagent system designed for laboratory use. It is formatted as a microassay, indicating a miniaturized test procedure suitable for processing multiple samples in a clinical microbiology or immunology laboratory environment.
Is the Lyme IgM Microassay a single-use or reusable device?
As an in vitro diagnostic reagent, the Lyme IgM Microassay is intended for single-use in the testing process. Reagents are consumed during the assay procedure and are not designed for reuse due to potential degradation, contamination risk, and loss of reactivity after initial use.
What regulatory pathway was used for the Lyme IgM Microassay and when was it cleared?
The Lyme IgM Microassay received FDA 510(k) clearance through the traditional pathway. It was cleared on May 2, 1990, under submission number K900572, and is substantially equivalent to a predicate device already on the market.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: LYME IGM MICROASSAY (K911330) — FDA 510 (k) | Innolitics, LYME IGM MICROASSAY (K900572) — FDA 510 (k) | Innolitics, LYME IGM MICROASSAY 510 (k) K900572 - FDA.report, PDF K900572 LYME IGM MICROASSAY - 510kdatabase.net, Diamedix Corp. · DeviceClearance
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K900572 | Class II | Active |
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Manufacturer
- Manufacturer
- Diamedix Corp.
Sources (1)
- FDA 510(k) K900572 24 fields · synced Sep 24, 2026