Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls

• K Number: K172868
• Device Name: Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls
• Manufacturer: The Binding Site Group Ltd.
• Date Cleared: 2018-02-28 ( 161 days)
• Product Code: DCN SYS
• Regulation Number: 866.5270

Intended Use

The Optilite C-Reactive Protein Reagent is intended for the quantitative in vitro determination of C-reactive protein (CRP) concentration in serum using the Binding Site Optilite analyser. Measurement of C-Reactive Protein aids in evaluation of the amount of injurv to body tissues and for evaluation of infection, tissue injurv, and inflammatory disorders. This test should be used in conjunction with other laboratory and clinical findings. The Optilite C-Reactive Protein Calibrator is intended for the calibration of the Optilite C-Reactive Protein Reagent on the Optilite analyser. The Optilite C-Reactive Protein Controls are intended for use in quality control by monitoring accuracy and precision for the Optilite C-Reactive Protein Reagent.

Device Description

The Optilite C-Reactive Protein Reagent is comprised of a dual wedge containing the following: Antiserum: Supplied in stabilised liquid form. Preservatives: 0.099% sodium azide, TRIS pH 8.0. Reaction Buffer: Containing 0.099% sodium azide, TRIS pH 7.5 as preservatives. The Optilite C-Reactive Protein Calibrator is comprised of the following: Pooled human serum, supplied in stabilised liquid form. Containing 0.099% sodium azide, as preservative. The Optilite C-Reactive Protein Controls are comprised of the following: Pooled human serum, supplied in stabilised liquid form. Containing 0.099% sodium azide, as preservative.

Predicate Devices

K083444

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a reagent and calibrator/controls for a quantitative in vitro diagnostic test for C-reactive protein, performed on a specific analyzer. There is no mention of AI, ML, image processing, or any computational analysis beyond standard quantitative measurement and statistical analysis of performance data.

Therapeutic

No.

Explanation: The device is an in vitro diagnostic (IVD) reagent intended for the quantitative determination of C-reactive protein (CRP) in serum, which aids in evaluating infection, tissue injury, and inflammatory disorders. IVD devices are used for diagnostic purposes, not for treating diseases or conditions.

Diagnostic

Yes

The device is intended for the "quantitative in vitro determination of C-reactive protein (CRP) concentration in serum," which is used to "aid in evaluation of the amount of injury to body tissues and for evaluation of infection, tissue injury, and inflammatory disorders." This squarely fits the definition of a diagnostic device as it provides information for the diagnosis of diseases or conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is comprised of reagents (Antiserum and Reaction Buffer) and calibrators/controls (pooled human serum), which are physical components, not software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The "Intended Use / Indications for Use" section explicitly states that the reagent is "intended for the quantitative in vitro determination of C-reactive protein (CRP) concentration in serum". The calibrator and controls are also intended for use with this reagent on the Optilite analyser.
• Device Description: The device components (reagent, calibrator, controls) are designed to be used outside of the body (in vitro) to analyze a biological sample (serum).
• Purpose: The measurement of CRP in serum is used to aid in the evaluation of various medical conditions (infection, tissue injury, inflammatory disorders), which is a diagnostic purpose.

The description clearly aligns with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the compatibility with potential recipients, or to monitor therapeutic measures.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Optilite C-Reactive Protein Reagent is intended for the quantitative in vitro determination of C-reactive protein (CRP) concentration in serum using the Binding Site Optilite analyser. Measurement of C-Reactive Protein aids in evaluation of the amount of injurv to body tissues and for evaluation of infection, tissue injurv, and inflammatory disorders. This test should be used in conjunction with other laboratory and clinical findings.

The Optilite C-Reactive Protein Calibrator is intended for the calibration of the Optilite C-Reactive Protein Reagent on the Optilite analyser.

The Optilite C-Reactive Protein Controls are intended for use in quality control by monitoring accuracy and precision for the Optilite C-Reactive Protein Reagent.

Product codes

DCN

Device Description

The Optilite C-Reactive Protein Reagent is comprised of a dual wedge containing the following:

Antiserum: Supplied in stabilised liquid form. Preservatives: 0.099% sodium azide, TRIS pH 8.0.

Reaction Buffer: Containing 0.099% sodium azide, TRIS pH 7.5 as preservatives.

The Optilite C-Reactive Protein Calibrator is comprised of the following: Pooled human serum, supplied in stabilised liquid form. Containing 0.099% sodium azide, as preservative.

The Optilite C-Reactive Protein Controls are comprised of the following: Pooled human serum, supplied in stabilised liquid form. Containing 0.099% sodium azide, as preservative.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Prescription use only

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

a. Precision/Reproducibility: The studies were based on CLSI EP5-A3, where 4 sera samples (targeted to 6.8mg/L, 9.5mg/L, 21.5mg/L and 65.4mg/L) were tested in 2 runs per day (each of the 2 runs in duplicate) over 21 days using 1 reagent lot on 3 analysers. Results met the acceptance criteria for total precision (%CV

Regulation Number and Section

§ 866.5270 C-reactive protein immunological test system.

(a)
Identification. A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.(b)
Classification. Class II (performance standards).

Summary

0

Optilite C-Reactive Protein Reagent, Calibrator and Controls 510(k) Summary

A. 510(k) Number:

K172868

B. Purpose for Submission:

New device

C. Measurand:

C-Reactive Protein

D. Type of Test:

Quantitative immunoturbidimetry

E. Applicant:

The Binding Site

F. Proprietary and Established Names:

Optilite® C-Reactive Protein Reagent, Optilite®C-Reactive Protein Calibrator, Optilite® C-Reactive Protein Controls.

G. Regulatory Information:

• 1. Requlation section:
     21 CFR 866.5270, C-reactive protein immunological test system.
• 2. Classification:
     Class II
• 3. Product code:
     DCN, System, Test, C-Reactive Protein
• 4. Panel:
     Immunology (82)

1

H. Intended use:

• 1. Intended use(s):
     The Optilite C-Reactive Protein Reagent is intended for the quantitative in vitro determination of C-reactive protein (CRP) concentration in serum using the Binding Site Optilite analyser. Measurement of C-Reactive Protein aids in evaluation of the amount of injurv to body tissues and for evaluation of infection, tissue injurv, and inflammatory disorders. This test should be used in conjunction with other laboratory and clinical findings.

The Optilite C-Reactive Protein Calibrator is intended for the calibration of the Optilite C-Reactive Protein Reagent on the Optilite analyser.

The Optilite C-Reactive Protein Controls are intended for use in quality control by monitoring accuracy and precision for the Optilite C-Reactive Protein Reagent.

2. Indication(s) for use:

Same as Intended use(s).

• 3. Special conditions for use statement(s):
     Prescription use only
• 4. Special instrument requirements:
     The Binding Site Optilite analyser

I. Device Description:

The Optilite C-Reactive Protein Reagent is comprised of a dual wedge containing the following:

Antiserum: Supplied in stabilised liquid form. Preservatives: 0.099% sodium azide, TRIS pH 8.0.

Reaction Buffer: Containing 0.099% sodium azide, TRIS pH 7.5 as preservatives.

The Optilite C-Reactive Protein Calibrator is comprised of the following: Pooled human serum, supplied in stabilised liquid form. Containing 0.099% sodium azide, as preservative.

The Optilite C-Reactive Protein Controls are comprised of the following: Pooled human serum, supplied in stabilised liquid form. Containing 0.099% sodium azide, as preservative.

J. Substantial equivalence information:

• 1. Predicate device name(s) and 510(k) number(s):
     Roche Diagnostics Tina-Quant C-Reactive Protein Gen. 3 (K083444)

2

2. Comparison with predicate:

Similarities

ltem	Device	Predicate
Intended use	Quantitative in vitro determination of
C-reactive protein (CRP).	Same.
Method	Turbidimetry	Same.
Reference Interval