Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a reagent kit for quantitative measurement using a specific analyzer, focusing on chemical components and analytical performance, with no mention of AI or ML.

Therapeutic

No
This device is an in vitro diagnostic (IVD) kit used for quantitative measurement of biomarkers, which aids in diagnosis and monitoring, not for direct treatment or therapy.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the kits "aid in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenström's macroglobulinaemia, AL amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings." This indicates its role in identifying or confirming the presence of diseases.

SaMD (Software as a Medical Device)

No

The device description explicitly details the composition of the kits, which are comprised of reagents (Latex Reagent, Calibrator and Controls, Reaction Buffer). These are physical components, not software. The device is an in vitro diagnostic (IVD) assay kit used with an analyzer, not a software-only device.

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 kits are intended for "quantitative in vitro measurement" of Kappa and Lambda free light chains in serum and urine. The term "in vitro" is a key indicator of an IVD.
Purpose: The measurement of these free light chains is stated to "aid in the diagnosis and monitoring" of various diseases. This aligns with the purpose of IVDs, which are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
Device Description: The description details the reagents used in the kits, which are designed to react with components in the patient's sample (serum and urine) outside of the body.
Care Setting: The indication "For prescription use only" is common for IVDs used in a clinical setting.

Therefore, based on the provided information, the Optilite Freelite Mx Kappa Free Kit and Optilite Freelite Mx Lambda Free Kit are clearly intended and designed for in vitro diagnostic use.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Optilite Freelite Mx Kappa Free Kit is intended for the quantitative in vitro measurement of Kappa free light chains in serum and urine using the Binding Site Optilite analyser. Measurement of free light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenström's macroglobulinaemia, AL amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings.

The Optilite Freelite Mx Lambda Free Kit is intended for the quantitative in vitro measurement of Lambda free light chains in serum and urine using the Binding Site Optilite analyser. Measurement of free light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenström's macroglobulinaemia, AL amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings.

Product codes

DFH, DEH

Device Description

The Optilite Freelite Mx Kappa Free Kit is comprised of the following reagents:

Latex Reagent: Sheep anti-Human Kappa (polyclonal monospecific) antibody (F(ab')2 fragment) bound to 200nm polystyrene latex particles. In 0.033M Glycine buffered saline pH8 (containing Sodium Azide (0.033%), Proclin (0.05%), Benzamidine (0.01%) and EACA (0.1%) as preservative plus BSA (0.033%)

Calibrator and Controls: Pooled human serum, supplied in stabilised liquid form. Containing 0.099% sodium azide, 0.1% EACA and 0.01% benzamidine as preservatives.

Reaction Buffer: Containing 0.099% sodium azide as a preservative.

The Optilite Freelite Mx Lambda Free Kit is comprised of the following reagents:

Latex Reagent: Sheep anti-Human Lambda (polyclonal monospecific) Free antibody (F(ab')2 fragment) bound to 200nm polystyrene latex particles. In 0.033M Glycine buffered saline pH8 (containing Sodium Azide (0.033%), Proclin (0.05%), Benzamidine (0.01%) and EACA (0.1%) as preservatives plus BSA (0.1665%))

Calibrator and Controls: Pooled human serum, supplied in stabilised liquid form. Containing 0.099% sodium azide, 0.1% EACA and 0.01% benzamidine as preservatives.

Reaction Buffer: Containing 0.099% sodium azide as a preservative.

Note - In Optilite Freelite kits, the latex reagent and reaction buffer are supplied in a single wedge with a chamber for each fluid. They are therefore labelled as a single component Optilite Kappa Free Mx Reagent or Optilite Lambda Free Mx Reagent.

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 (Part 21 CFR 801 Subpart D)

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

Analytical Performance:
- Precision/Reproducibility:
  - Kappa: Within-run, between-run, between-day, and between-instrument precision determined by testing four urine sample pools over 21 days with two runs per day using one reagent lot on three analysers.
    - Sample 1 (mean 5.49): Total SD 0.42, %CV 7.6
    - Sample 2 (mean 33.08): Total SD 2.72, %CV 8.2
    - Sample 3 (mean 99.16): Total SD 6.99, %CV 7.1
    - Sample 4 (mean 179.12): Total SD 15.68, %CV 8.8
  - Lambda: Within-run, between-run, between-day, and between-instrument precision determined by testing five urine sample pools over 23 days with two runs per day using one reagent lot on three analysers.
    - Sample 1 (mean 4.48): Total SD 0.33, %CV 7.3
    - Sample 2 (mean 7.19): Total SD 0.62, %CV 8.7
    - Sample 3 (mean 54.37): Total SD 4.45, %CV 8.2
    - Sample 4 (mean 109.27): Total SD 8.89, %CV 8.1
    - Sample 5 (mean 133.46): Total SD 11.50, %CV 8.6
- Linearity/Assay Reportable Range: Linearity confirmed using serially diluted urine samples for Kappa Free (2.9 – 127mg/L) and Lambda Free (5.2 – 139mg/L). Results showed linearity over ranges of 2.383-142.687mg/L (Kappa) and 3.87 -160.02mg/L (Lambda) with deviation from linearity ≤ 10%.
- Traceability, Stability, Expected values: Traceability to internally produced master calibrator. Stability details not applicable for this submission, as they were evaluated in K150658.
- Detection Limit: Determined in accordance with CLSI EP17-A using serum and urine matrices.
  - Kappa Free (Serum): LoB 0.195mg/L, LoD 0.224mg/L, LoQ 0.330mg/L
  - Kappa Free (Urine): LoB 0.210mg/L, LoD 0.232mg/L, LoQ 0.330mg/L
  - Lambda Free (Serum): LoB 0.285mg/L, LoD 0.393mg/L, LoQ 0.740mg/L
  - Lambda Free (Urine): LoB 0.080mg/L, LoD 0.184mg/L, LoQ 0.740mg/L
- Analytical Specificity:
  - Interference: No significant assay interference observed for Kappa when tested with Ascorbic Acid (200 mg/L), Albumin (5 g/L), Bilirubin (100 mg/L), Bortezomib (6 mg/mL), Cyclophosphamide (330 mg/mL), Digoxin (0.375 µg/mL), Haemoglobin (240 mg/L), Penicillin (75 mg/L), Phenytoin (15 mg/L), Theophylline (150 mg/L). No significant assay interference observed for Lambda when tested with Ascorbic Acid (200 mg/L), Albumin (5 g/L), Bilirubin (100 mg/L), Bortezomib (3.6 mg/mL), Cyclophosphamide (330 mg/mL), Digoxin (0.375 µg/mL), Haemoglobin (250 mg/L), Penicillin (75 mg/L), Phenytoin (15 mg/L), Theophylline (150 mg/L).
  - Cross Reactivity: "No significant cross reaction was observed during testing for the predicate device. The specificity of the antisera is unchanged."
- Antigen Excess Detection: Evaluated in K150658.
Comparison Studies:
- Method Comparison with Predicate Device:
  - Kappa Free: 165 urine samples analyzed using Optilite Freelite Mx Kappa Free kit and an alternative commercially available assay. Passing Bablok regression analysis: y = 1.02x - 0.21 (mg/L), correlation coefficient r = 0.992.
  - Lambda Free: 115 urine samples analyzed using Optilite Freelite Mx Lambda Free kit and an alternative commercially available assay. Passing Bablok regression analysis: y = 1.11x – 0.27 (mg/L), correlation coefficient r = 0.947.
Clinical Studies:
- Clinical Sensitivity/Specificity: (Based on 2x2 tables comparing Test Assay vs. Predicate Assay)
  - Kappa (N=166):
  - Positive Agreement: 90.7% (95% CI: 82.7% to 95.2%)
  - Negative Agreement: 98.8% (95% CI: 93.3% to 99.8%)
  - Overall Agreement: 94.6% (95% CI: 90.0% to 97.1%)
  - Lambda (N=168):
  - Positive Agreement: 73.7% (95% CI: 62.8% to 82.3%)
  - Negative Agreement: 100.0% (95% CI: 96.0% to 100.0%)
  - Overall Agreement: 88.1% (95% CI: 92.3% to 92.2%)
Expected values/Reference range:
- Normal adult urine:
  - Kappa free: Mean 7.64 mg/L, Median 4.54 mg/L, Reference Limit (97.5th Percentile) 32.90 mg/L
  - Lambda free: Mean 1.03 mg/L, Median 0.74 mg/L, Reference Limit (97.5th Percentile) 3.79 mg/L

Key Metrics

Kappa Free Method Comparison: correlation coefficient r = 0.992
Lambda Free Method Comparison: correlation coefficient r = 0.947
Kappa Clinical Agreement:
- Positive Agreement: 90.7% (95% CI: 82.7% to 95.2%)
- Negative Agreement: 98.8% (95% CI: 93.3% to 99.8%)
- Overall Agreement: 94.6% (95% CI: 90.0% to 97.1%)
Lambda Clinical Agreement:
- Positive Agreement: 73.7% (95% CI: 62.8% to 82.3%)
- Negative Agreement: 100.0% (95% CI: 96.0% to 100.0%)
- Overall Agreement: 88.1% (95% CI: 92.3% to 92.2%)

Predicate Device(s)

Freelite® Human Kappa Free Kit for use on the Siemens BN™II (K) and Freelite® Human Lambda Free Kit for use on the Siemens BN™II (K040009)

Reference Device(s)

Optilite Analyser (Indiko) (K110035)

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 866.5550 Immunoglobulin (light chain specific) immunological test system.

(a)
Identification. An immunoglobulin (light chain specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques both kappa and lambda types of light chain portions of immunoglobulin molecules in serum, other body fluids, and tissues. In some disease states, an excess of light chains are produced by the antibody-forming cells. These free light chains, unassociated with gamma globulin molecules, can be found in a patient's body fluids and tissues. Measurement of the various amounts of the different types of light chains aids in the diagnosis of multiple myeloma (cancer of antibody-forming cells), lymphocytic neoplasms (cancer of lymphoid tissue), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus.(b)
Classification. Class II (performance standards).

Summary

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 23, 2018

The Binding Site Group Ltd Andrea Thomas Regulatory Affairs Officer 8 Calthorpe Road Edgbaston Birmingham, B15 1QT Gb

Re: K173732

Trade/Device Name: Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit Regulation Number: 21 CFR 866.5550 Regulation Name: Immunoglobulin (light chain specific) immunological test system Regulatory Class: Class II Product Code: DFH, DEH Dated: July 26, 2018 Received: July 31, 2018

Dear Andrea Thomas:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

1

statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Image /page/1/Picture/6 description: The image shows the name "Kelly Oliner -S" in a large, bold, sans-serif font. The text is black against a white background. The letters are evenly spaced and the text is horizontally aligned.

For

Lea Carrington, Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K173732

Device Name

Optilite Freelite Mx Kappa Free Kit (LK016.M.OPT.A)

Optilite Freelite Mx Lambda Free Kit (LK018.M.OPT.A)

Indications for Use (Describe)

The Optilite Freelite Mx Kappa Free Kit is intended for the quantitative in vitro measurement of Kappa free light chains in serum and urine using the Binding Site Optilite analyser. Measurement of free light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenström's macroglobulinaemia, AL amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings.

The Optilite Freelite Mx Lambda Free Kit is intended for the quantitative in vitro measurement of Lambda free light chains in serum and urine using the Binding Site Optilite analyser. Measurement of free light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenström's macroglobulinaemia, AL amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

Optilite Freelite Mx Kappa Free Kit and Optilite Freelite Lambda Free Submission Summary

Date prepared: 23d Auqust 2018

A. 510(k) Number:

K173732

B. Purpose for Submission:

Addition of a urine matrix and an addition of a 1+0 sample dilution to a cleared IVD assay (K150658)

C. Measure and:

Kappa (k) free light chains and Lambda (λ) free light chains

D. Type of Test: Quantitative, Turbidimetry

E. Applicant:

The Binding Site Group, Ltd. Contact person: Andrea Thomas Address: 8 Calthorpe Road, Birmingham, B15 1QT, United Kingdom Contact number: +44(0)121 456 9500

F. Proprietary and Established Names:

Optilite® Freelite Mx™ Kappa Free Kit Optilite® Freelite Mx™ Lambda Free Kit

G. Regulatory Information:

1. Requlatory Section: 21 CFR 866.5550, Immunoglobulin (light chain specific) immunological test system
1. Classification: Class II
1. Product Code:

DFH - Kappa antigen, antiserum, control DEH - Lambda antigen, antiserum, control

Panel: Immunology (82)

H. Intended Use:

1. Intended use(s):
  The Optilite Freelite Mx Kappa Free Kit is intended for the quantitative in vitro measurement of Kappa free light chains in serum and urine using the Binding Site Optilite analyser. Measurement of free light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinaemia, AL amyloidosis, light chain deposition disease and

4

connective tissue diseases such as systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings.

The Optilite Freelite Mx Lambda Free Kit is intended for the quantitative in vitro measurement of Lambda free light chains in serum and urine using the Binding Site Optilite analyser. Measurement of free light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenström's macroglobulinaemia, AL amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings.

Indication(s) for use:

Same as intended use.

1. Special conditions for use statement(s): For prescription use only.
  Warning: The kappa free light chain results for a given specimen determined with assays from different manufacturers or on different systems can vary due to differences in assay methods and reagent specificity. The results reported by the laboratory to the physician must include the identity of the kappa free light chain assay used. Values obtained with different assays or systems cannot be used interchangeably. If, in the course of serially monitoring a patient, the assay or system used for determining kappa free light chain levels is changed, additional sequential testing should be carried out. Prior to changing assay or system, the laboratory MUST confirm baseline values for patients being serially monitored

Warning: The lambda free light chain results for a given specimen determined with assays from different manufacturers or on different systems can vary due to differences in assay methods and reagent specificity. The results reported by the laboratory to the physician must include the identity of the lambda free light chain assay used. Values obtained with different assays or systems cannot be used interchangeably. If, in the course of serially monitoring a patient, the assay or system used for determining lambda free light chain levels is changed, additional sequential testing should be carried out. Prior to changing assay or system, the laboratory MUST confirm baseline values for patients being serially monitored.

Special instrument requirements:

Optilite Analyser (Indiko) (K110035)

5

Device Description: .