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Optilite Low Level Albumin Kit

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K153560

by The Binding Site Group Ltd

Identifiers

510(k) Number
K153560 FDA 510(k)
FDA Product Code
DCF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.5040 FDA 510(k)
Regulation Number
866.5040 FDA 510(k)
Advisory Committee
Immunology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Optilite Low Level Albumin Kit is an in vitro diagnostic reagent designed for the quantitative measurement of albumin in cerebrospinal fluid (CSF), urine, and serum. It falls under the category of antigen, antiserum, and control reagents, aiding in the assessment of protein levels for diagnostic purposes in clinical settings.

This kit is intended for use with the Optilite analyser and is supplied as a single-use reagent. It is classified under FDA 510(k) clearance (K153560) and IVDR compliance, with no explicit MRI safety or sterility specifications noted in the data. The device is regulated under the classification of Class II (device class=2) and is intended for laboratory use in immunology-related diagnostics.

Frequently asked questions

What types of samples can the Optilite Low Level Albumin Kit measure, and why is this important for clinical use?

The Optilite Low Level Albumin Kit is designed to quantitatively measure albumin levels in cerebrospinal fluid (CSF), urine, and serum. This versatility is important for clinical use because albumin measurement in these different fluids can help diagnose or monitor conditions like neurological disorders (via CSF), kidney disease (via urine), or liver function (via serum). The kit’s ability to analyze multiple sample types streamlines workflows in immunology-focused laboratories.

Is the Optilite Low Level Albumin Kit intended for single-use or repeated use, and how does this affect storage or handling?

The kit is explicitly supplied as a single-use reagent, meaning each kit should only be used once per test. This design reduces the risk of cross-contamination and ensures consistent, reliable results. Since it’s single-use, proper storage (as per manufacturer guidelines) is critical to maintain reagent integrity until use, and any unused portions must be discarded after opening.

What analyzer is required to use the Optilite Low Level Albumin Kit, and why is this compatibility important?

The kit is designed exclusively for use with the Optilite analyzer, a dedicated platform for immunology-related diagnostics. This compatibility ensures accurate and reproducible albumin measurements, as the analyzer’s calibration and software are optimized for the kit’s reagents. Using it with other analyzers could lead to inaccurate results or system errors.

Are there any specific storage requirements or conditions mentioned for the Optilite Low Level Albumin Kit?

The provided data does not explicitly detail storage conditions (e.g., temperature, light exposure) for the kit. However, as a single-use reagent for in vitro diagnostics, it should generally be stored according to standard laboratory practices for immunology reagents—typically at room temperature or refrigerated, protected from moisture and direct light. Always refer to the manufacturer’s instructions for precise storage guidance to preserve stability and performance.

How is the regulatory classification of this kit relevant to its use in clinical or laboratory settings?

The kit is classified as Class II under FDA regulations and complies with the In Vitro Diagnostic Regulation (IVDR) in the EU. This classification indicates it poses moderate risk and requires validation for safety and performance before clinical use. Clinicians and laboratories can rely on its regulatory clearance as evidence of rigorous testing, ensuring it meets standards for accuracy, reliability, and intended diagnostic purposes in immunology-related assessments.

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: Optilite™ Analyser | Binding Site - Thermo Fisher Scientific, Optilite Low Level Albumin Kit (K153560) — FDA 510 (k) | Innolitics, K153560 - Optilite Low Level Albumin Kit | FDA 510 (k), PDF Optilite® Low Level Albumin Kit

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

IVDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
The Binding Site Group Ltd
FDA Applicant
The Binding Site Group , Ltd.

Sources (2)

  • FDA 510(k) K153560 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026