MYDAS Brand Solid-Phase Antibody Reagents
by Intl. Immunoassay Laboratories, Inc. 510(k)
Active
510(k) K903441
Overview
This device is a solid-phase antibody reagent set used in clinical chemistry for fluorometric measurement of creatine kinase (CK) or its isoenzymes. It functions as an analytical tool to support enzyme activity testing in laboratory settings.
The reagents are supplied by Intl. Immunoassay Laboratories, Inc. and are intended for in vitro diagnostic use. They are regulated under FDA product code JHX and classification 862.1215 as part of a Class II device system. The product was authorized through the traditional 510(k) pathway with a substantially equivalent determination.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK903441 | Date6 Nov 1990 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- Full name
- Mydas(Tm) Brand Solid-Phase Antibody Reagents
- 510(k) Number
- FDA Product Code
- JHX
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1215
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Intl. Immunoassay Laboratories, Inc.
Questions
What is the MYDAS reagent set used for?
It is a solid-phase antibody reagent set designed for fluorometric measurement of creatine kinase (CK) or its isoenzymes. It supports enzyme activity testing in clinical chemistry laboratories as an in vitro diagnostic tool.
How are the reagents supplied?
The reagents are supplied by Intl. Immunoassay Laboratories, Inc., located at 1900 Wyatt Dr., #11, Santa Clara, CA 95054. They are provided as a complete set for use in standardized laboratory assays.
Is the MYDAS reagent single-use or reusable?
The data does not specify whether the reagents are single-use or reusable. Users should consult the manufacturer’s package insert or product labeling for instructions on handling, aliquoting, and storage to determine appropriate reuse protocols if applicable.
What sizes or models are available?
The device data does not list specific sizes, volumes, or model variants. The product is identified as MYDAS(TM) BRAND SOLID-PHASE ANTIBODY REAGENTS without reference to multiple configurations. Contact the manufacturer for available pack sizes or lot information.
How should the reagents be stored?
Storage conditions are not detailed in the provided device record. For stability and performance, follow the manufacturer’s instructions regarding temperature, light exposure, and shelf life as specified on the product label or in the accompanying documentation.