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Platelia Lyme IgM

FDA 510(k)

Class II (US FDA 510(k))

510(k) K081362

by Bio-Rad

Identifiers

510(k) Number
K081362 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 Platelia Lyme IgM is a reagent, Borrelia serological reagent, used for the detection of specific IgM antibodies to Borrelia burgdorferi sensu lato in human serum. It is a microbiology device intended for use in laboratory testing to support the diagnosis of Lyme borreliosis.

Supplied as a 96-well plate format (catalog reference 72951), the device is intended for in vitro diagnostic use. It received FDA 510(k) clearance (K081362) as a substantially equivalent device under regulation number 866.3830, with product code LSR, and is classified as a Class II medical device.

Frequently asked questions

What is the Platelia Lyme IgM device used for?

The Platelia Lyme IgM is a reagent used for the detection of specific IgM antibodies to Borrelia burgdorferi sensu lato in human serum. It is intended for in vitro diagnostic use in laboratory testing to support the diagnosis of Lyme borreliosis, as stated in the device description.

How is the Platelia Lyme IgM supplied and what is its format?

The device is supplied as a 96-well plate format with catalog reference 72951. This format is designed for laboratory use in processing multiple patient samples simultaneously for the detection of IgM antibodies to Borrelia burgdorferi.

Is the Platelia Lyme IgM a single-use or reusable device?

The Platelia Lyme IgM is intended for single-use in vitro diagnostic testing. As a reagent-based assay supplied in a disposable 96-well plate format, it is not designed for reuse after testing, consistent with standard clinical laboratory practices for such reagents.

What regulatory pathway was used for the Platelia Lyme IgM, and what is its classification?

The Platelia Lyme IgM received FDA 510(k) clearance (K081362) as a substantially equivalent device under regulation number 866.3830. It is classified as a Class II medical device with product code LSR, based on the traditional 510(k) submission pathway.

What storage conditions are implied for the Platelia Lyme IgM based on its classification and supply format?

While specific storage conditions are not explicitly stated in the provided data, as an in vitro diagnostic reagent supplied in a 96-well plate format, it is implied that the device requires refrigerated storage (typically 2–8°C) to maintain reagent stability, consistent with standard handling for serological assays of this type.

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: PDF Platelia Lyme IgM and IgG EIA - Bio-Rad, 1 PLATELIA™ LYME IgM 1 lemez – 96 72951, Borreliosis (Lyme Disease) - Bio-Rad, PLATELIA™ LYME IgM 1 plaque - 96 72951

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Bio-Rad

Sources (1)

  • FDA 510(k) K081362 24 fields · synced Sep 19, 2026