← Back to catalogue

Lyphochek Serum Ref. Standard-Bovine

FDA 510(k)

Class II (US FDA 510(k))

510(k) K832695

by Bio-Rad

Identifiers

510(k) Number
K832695 FDA 510(k)
FDA Product Code
JIX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1150 FDA 510(k)
Regulation Number
862.1150 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Lyphochek Serum Reference Standard-Bovine is a Calibrator, Multi-Analyte Mixture designed for clinical chemistry applications. It serves as a bovine-derived reference material for validating and standardizing laboratory assays, ensuring accuracy and consistency in analytical measurements across multiple methodologies.

Supplied as a lyophilized powder, this reference standard is intended for laboratory use in clinical chemistry settings. It is regulated under FDA 510(k) clearance (K832695) and classified as a Class II device, with no indication of sterility or single-use/reusable designation. Storage and handling conditions are not specified in the data, but it is intended for use in controlled laboratory environments.

Frequently asked questions

What is the Lyphochek Serum Reference Standard-Bovine used for in a clinical setting?

The Lyphochek Serum Reference Standard-Bovine is a calibrator and multi-analyte mixture designed specifically for clinical chemistry laboratories. It serves as a bovine-derived reference material to validate and standardize assays, ensuring accuracy and consistency across various analytical methods. This helps laboratories maintain reliable test results for patient diagnostics.

How is the Lyphochek Serum Reference Standard-Bovine supplied, and what form does it take?

The product is supplied as a lyophilized (freeze-dried) powder, which means it arrives in a dry, stable form that requires reconstitution with a compatible solvent before use. This format helps preserve its stability during storage and shipping while extending shelf life.

Is the Lyphochek Serum Reference Standard-Bovine intended for single-use or can it be reused?

The provided data does not explicitly state whether the Lyphochek Serum Reference Standard-Bovine is single-use or reusable. Since it is a calibrator and reference material, proper handling and documentation of usage would be required to determine its suitability for reuse, but no specific reuse instructions are given.

What regulatory pathway was followed for FDA clearance of this device?

The Lyphochek Serum Reference Standard-Bovine was cleared through the traditional 510(k) pathway under FDA clearance number K832695, with a substantially equivalent (SESE) determination by the Clinical Chemistry (CH) Advisory Committee. It is classified as a Class II device, indicating moderate regulatory oversight.

Are there any specific storage instructions provided for this product?

The data does not specify exact storage conditions (e.g., temperature, humidity, or light exposure) for the Lyphochek Serum Reference Standard-Bovine. However, since it is intended for laboratory use in controlled environments, it is reasonable to assume standard laboratory storage practices (e.g., refrigeration or room temperature, as per manufacturer guidelines) should be followed to maintain its integrity.

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: Lyphochek Assayed Chemistry Control - Bio-Rad, LYPHOCHEK SERUM REF. STANDARD-BOVINE (K832695) — FDA 510 (k) | Innolitics, Lyphochek Drug Free Serum - Bio-Rad, Bio-Rad Lyphochek Control Values | PDF | Magnesium | Creatinine

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Bio-Rad

Sources (1)

  • FDA 510(k) K832695 24 fields · synced Sep 19, 2026