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ESP Culture System II - Myco Susceptibility Testing

FDA 510(k)

Class II (US FDA 510(k))

510(k) K972772

by Trek Diagnostic Systems, Inc.

Identifiers

510(k) Number
K972772 FDA 510(k)
FDA Product Code
MJA FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.1640 FDA 510(k)
Regulation Number
866.1640 FDA 510(k)
Advisory Committee
Microbiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The ESP Culture System II is an automated system for the detection of microbial growth from blood and other normally sterile body fluids. It is used for susceptibility testing of Mycobacterium tuberculosis, combining Myco broth, a growth supplement, and primary antibiotics with a detection system that automatically incubates and continuously monitors culture bottles inoculated with M. tb isolates from various specimen sources.

The device is supplied as part of a system for laboratory use in microbiology settings. It has received FDA 510(k) clearance (K972772) and is classified as a Class II device under regulation number 866.1640 with product code MJA. The system is intended for use in clinical laboratories and is not described as sterile, single-use, or MRI-safe in the provided data.

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: Esp Culture System Ii - Myco Susceptibility Testing (K972772) — Fda 510 ..., PDF Product Catalog, VERSATREK MYCO PZA KIT by TREK DIAGNOSTIC SYSTEMS, INC. | FDA 510 (k ..., www.accessdata.fda.gov

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Trek Diagnostic Systems, Inc.

Sources (1)

  • FDA 510(k) K972772 24 fields · synced Sep 22, 2026