← Back to catalogue

Creatinine LiquiColor

FDA 510(k)

Class II (US FDA 510(k))

510(k) K050283

by Stanbio Laboratory

Identifiers

510(k) Number
K050283 FDA 510(k)
FDA Product Code
JFY FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1225 FDA 510(k)
Regulation Number
862.1225 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Creatinine LiquiColor is an enzymatic method for quantitative measurement of creatinine in serum and urine. Classified as a clinical chemistry device, it employs a colorimetric assay to determine creatinine levels, providing accurate and reliable results for diagnostic evaluation of renal function.

This device is supplied as a single-use reagent kit for manual or automated laboratory analysis. It requires no special storage conditions beyond standard laboratory refrigeration and is compatible with common clinical analyzers. The test demonstrates linearity up to 13 mg/dL (1,150 µmol/L) in serum and 500 mg/dL (44,200 µmol/L) in urine, with high-concentration samples requiring dilution. Authorized under FDA 510(k) clearance (K050283), it adheres to regulatory standards for clinical chemistry diagnostics.

Frequently asked questions

What types of samples can the Creatinine LiquiColor test, and what are its measurement limits for each?

The Creatinine LiquiColor is designed for quantitative measurement of creatinine in both serum and urine samples. For serum, it provides accurate results up to 13 mg/dL (1,150 µmol/L), while for urine, it measures up to 500 mg/dL (44,200 µmol/L). High-concentration urine samples may require dilution to ensure precise readings within the assay’s linear range.

Is the Creatinine LiquiColor kit intended for single-use, and how should it be stored?

Yes, the Creatinine LiquiColor is supplied as a single-use reagent kit for manual or automated laboratory analysis. Storage is straightforward—it requires only standard laboratory refrigeration (no special conditions) and is compatible with common clinical analyzers.

How is the Creatinine LiquiColor authorized for use, and what regulatory pathway was followed?

The Creatinine LiquiColor received FDA 510(k) clearance (K050283) under the traditional pathway, demonstrating substantial equivalence to a predicate device. It falls under the Clinical Chemistry advisory committee (CH) and is classified as a Class II device (device code: JFY).

Can this device be used with automated clinical analyzers, and does it require any special handling?

Yes, the Creatinine LiquiColor is compatible with common clinical analyzers, making it suitable for both manual and automated laboratory workflows. No special handling is required beyond standard refrigeration and adherence to the manufacturer’s (Stanbio Laboratory) instructions for use.

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: STANBIO Creatinine | PDF | Creatinine - Scribd, Stanbio Laboratory | Fisher Scientific, PDF CREATININE liquicolor

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
Stanbio Laboratory

Sources (1)

  • FDA 510(k) K050283 24 fields · synced Sep 20, 2026