(140 days)
Not Found
No
The device description details a turbidimetric assay based on light scatter measurements and calibration curves, which is a standard laboratory technique and does not involve AI/ML. The summary explicitly states "Mentions AI, DNN, or ML: Not Found".
No
This device is an in-vitro diagnostic (IVD) test kit intended for the quantification of specific proteins in human serum, with results used in conjunction with other clinical findings for previously diagnosed conditions. It does not directly provide therapy.
No
The text explicitly states: "This assay has not been established for the diagnosis, monitoring and prognosis of Waldenström's macroglobulinaemia." This indicates it's not a diagnostic device.
No
The device description clearly outlines a turbidimetry-based assay involving reagents (antibody solution), a reaction vessel (cuvette), and a light source and detector to measure light scatter. This indicates a physical in-vitro diagnostic device, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for the in-vitro quantification" of substances in human serum. "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Device Description: The description details a laboratory test procedure involving the addition of a test sample (human serum) to a solution containing antibodies and measuring the reaction using light. This is a typical in vitro diagnostic method.
- Sample Type: The device uses human serum, which is a biological sample taken from the body for analysis outside the body.
- Purpose: The purpose is to quantify specific proteins (IgM kappa and IgM lambda) in the serum to provide information for use with previously diagnosed Waldenström's macroglobulinaemia. While it's not for initial diagnosis, it provides diagnostic information for managing a known condition.
All these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Hevylite Human IgM Kappa kit for use on SPAPLUS is intended for the in-vitro quantification of IgM kappa (combined u heavy and k light chain) concentration in human serum on the Binding Site SPAPLUS. The test result is to be used with previously diagnosed Waldenström's macroglobulinaemia in conjunction with other clinical findings. This assay has not been established for the diagnosis of Waldenstrom's macroglobulinaemia.
Hevylite Human IgM Lambda kit for use on SPAPLUS is intended for the in-vitro quantification of IgM lambda (combined u heavy and lambda light chain) in human serum on the Binding Site SPAPLUS. The test result is to be used with previously diagnosed Waldenstrom's macroglobulinaemia. The test result is to be used in conjunction with other clinical findings.
This assay has not been established for the diagnosis, monitoring and prognosis of Waldenström's macroglobulinaemia.
Product codes (comma separated list FDA assigned to the subject device)
PDE, PDF
Device Description
Not Found
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
Not Found
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)
Precision/Reproducibility:
The precision study was based on CLSI (EP5-A2) Evaluation of Precision Performance of Quantitative Measurement Methods. Precision was initially evaluated using three samples of processed sera pooled with fully preserved citrate beta alanine that together had analyte levels that spanned measuring range of the assays (IgM Kappa 0.2 - 5.0g/L, IgM Lambda: 0.18 - 4.50g/L).
The 21 day precision study was performed by running the sera samples in duplicate (within-run analysis), two runs per day (between-run analysis) over 21 days (between-day) using three reagent lots (Batches 1, 2 and 3) and four instruments (SPAPLUS 2, 5, 7 and 9).
An additional "bridging" precision study was carried out. Precision was evaluated using five samples of pooled native sera that together had analyte levels that spanned the measuring range of the assays (IgM Kappa 0.2 - 5.0g/L, IgM Lambda: 0.18 - 4.50g/L).
The 21 day bridging precision study was performed by running the sera samples in duplicate (within-run analysis), two runs per day (between-run analysis) over 21 days (between-day) using one reagent lot and three instruments (SPAPLUS 1, 9 and 12).
All precision studies passed the acceptance criteria of CV
§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).
0
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 6, 2014
THE BINDING SITE GROUP LTD C/O MS SUZANNE HORNE, REGULATORY AFFAIRS MANAGER 8 CALTHORPE ROAD, EDGBASTON BIRMINGHAM, WEST MIDLANDS B15 10T United Kingdom
Re: K140686
Trade/Device Name: Hevylite Human IgM Kappa Kit For Use On SPAPLIS® Hevylite Human IgM Lambda Kit For Use On SPAPLUS® Regulation Number: 21 CFR 866.5510 Regulation Name: Immunoglobulins A, G, M, D, and E immunological test system Regulatory Class: II Product Code: PDE, PDF Dated: July 04, 2014 Received: July 07, 2014
Dear Ms. Horne:
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. 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 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
1
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Maria M. Chan -S
Maria M. Chan, Ph.D. 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) K140686
Device Name
Hevylite Human IgM Kappa Kit for use on SPAPLUS Hevylite Human IgM Lambda Kit for use on SPAPLUS
Indications for Use (Describe)
Hevylite Human IgM Kappa kit for use on SPAPLUS is intended for the in-vitro quantification of IgM kappa (combined u heavy and k light chain) concentration in human serum on the Binding Site SPAPLUS. The test result is to be used with previously diagnosed Waldenström's macroglobulinaemia in conjunction with other clinical findings. This assay has not been established for the diagnosis of Waldenstrom's macroglobulinaemia.
Hevylite Human IgM Lambda kit for use on SPAPLUS is intended for the in-vitro quantification of IgM lambda (combined u heavy and A light chain) in human serum on the Binding Site SPAPLUS. The test result is to be used with previously diagnosed Waldenstrom's macroglobulinaemia. The test result is to be used in conjunction with other clinical findings.
This assay has not been established for the diagnosis, monitoring and prognosis of Waldenström's macroglobulinaemia.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Hevylite® Human IgM Kappa and IgM Lambda Kits for use on SPAPLUS®
510(k) Summarv
Version: 5th August 2014
Contact Information: Suzanne Horne The Binding Site 8 Calthorpe Road Edgbaston Birmingham, B15 1QT West Midlands U.K Telephone: +44 121 456 9500 Email: Suzanne.Horne@bindingsite.co.uk
Hevylite® and SPAPLUS® are registered trademarks of the Binding Site Group Ltd, Birmingham, UK. BN™II is a trademark of Siemens Healthcare Diagnostics Inc.
Trade Names:
Hevylite® Human IgM Kappa Kit for use on SPAPLUS® Hevylite® Human IgM Lambda Kit for use on SPAPLUS®
Classification Names:
| Product
Classification
Code | Product Code Name | Device
Class | Classification
Panel | 21 CFR Section |
|-----------------------------------|--------------------------------------------------------------|-----------------|-------------------------|----------------|
| PDE | Immunoglobulin M Kappa
Heavy and light chain
combined | II | Immunology | 866.5510 |
| PDF | Immunoglobulin M Lambda
heavy and light chain
combined | II | Immunology | 866.5510 |
Intended use:
Hevylite Human IgM Kappa Kit for use on SPAPLUS is intended for the in vitro quantification of IgM Kappa (combined u heavy and k light chain) concentration in human serum on SPAPLUS. The test result is to be used with previously diagnosed Waldenström's macroglobulinaemia in conjunction with other clinical and laboratory findings.
This assay has not been established for the diagnosis, monitoring and prognosis of Waldenstrom's macroglobulinaemia.
Hevylite Human IgM Lambda Kit for use on SPAPLUS is intended for the in vitro quantification of IgM Lambda (combined u heavy and À light chain) concentration in human serum on SPAPLUS. The test
Image /page/3/Picture/13 description: The image contains the words "Binding Site" in bold, black font. To the right of the words is a logo that contains a yellow circle with a black silhouette of the British Isles. Below the circle are two black arms that are holding up the circle. Below the arms is a yellow rectangle with the words "The Binding Site" in black font.
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result is to be used with previously diagnosed Waldenstrom's macroglobulinaemia in conjunction with other clinical and laboratory findings.
This assay has not been established for the diagnosis, monitoring and prognosis of Waldenstrom's macroglobulinaemia.
Test Principle:
Evaluating the concentration of a soluble antigen (e.g. IgM Kappa and IgM Lambda) by turbidimetry involves the addition of the test sample to a solution containing the appropriate antibody (anti-IgM kappa and anti-IgM lambda) in a reaction vessel or cuvette. A beam of light id passed through the cuvette and, as the antigen-antibody reaction proceeds, the light passing through the cuvette is scattered increasingly as insoluble immune complexes are formed. Light scatter is monitored by measuring the decrease in intensity of the incident beam of light. The antibody in the cuvette is in excess so the amount of immune complex formed is proportional to the antigen concentration. A series of calibrators of known antigen concentration are assayed initially to produce a calibration curve of measured light scatter versus antigen concentration. Samples of unknown antigen concentration can then be assayed and the results read from the calibration curve.
Substantial Equivalence Information:
Predicate device: Hevylite Human IgM Kappa and IgM Lambda Kits for use on Siemens BN™II Systems (K113823)
Comparison with Predicate:
Similarities
| Item | Device | Predicate |
|---|---|---|
| Intended use | In-vitro quantification of IgM kappa and IgM Lambda | In-vitro quantification of IgM kappa and IgM Lambda |
| Specimen Type | Serum | Serum |
| Antibody | Sheep anti-IgM kappa and anti- | |
| IgM lambda coated onto | ||
| polystyrene latex | Sheep anti-IgM kappa and anti- | |
| IgM lambda coated onto | ||
| polystyrene latex | ||
| Open Vial Stability | 1 month | 1 month |
Differences
| Item | Device | Predicate |
|---|---|---|
| Standard Measuring | ||
| range | IgM Kappa: 0.2 -5.0g/L (1/10) | |
| IgM Lambda: 0.18 – 4.50g/L | ||
| (1/10) | IgM Kappa: 0.2 – 6.4g/L (1/100) | |
| IgM Lambda: 0.175-5.60g/L | ||
| (1/100) | ||
| Reference Interval | IgM Kappa: 0.19 – 1.63g/L | |
| IgM Lambda: 0.12 – 1.01g/L | ||
| IgM Kappa/Lambda: 1.18 – 2.74 | IgM Kappa: 0.29 – 1.82g/L | |
| IgM Lambda: 0.17 - 0.94g/L | ||
| IgM Kappa/Lambda: 0.96 – 2.30 | ||
| Method | Turbidimetry | Nephelometry |
| Instrument | Binding Site SPAPLUS | Siemens Behring Nephelometer II |
| (BNTMII) |
Discussion:
The differences between the methods of the devices do not affect the safety and effectiveness as they both measure light scatter, the only difference is where the detector is in the light source.
Image /page/4/Picture/14 description: The image contains the words "Binding Site" in large, bold, black font. To the right of the words is a logo that contains a yellow circle with a black silhouette of the United Kingdom inside. Below the circle are two black hands holding the circle up. Below the hands is a yellow rectangle with the words "The Binding Site" written in black font.
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The differences in the measuring ranges do not affect the safely and effectiveness as they both have the same lower limit and any results >5.0g/L on the kappa kit and >4.5g/L on the lambda kit will not have a clinical impact on patients if the results were quantified on the BN™II kit or reported as >5.0g/L on the kappa kit and >4.5g/L on the lambda kit.
The differences in the reference intervals do not affect the safety and effectiveness as the measuring ranges for the SPAPLUS kits were generated and the measuring ranges on the BN™II kits were from literature with different samples. The comparison data shows that the results obtained on both sets of kits are equivalent to each other.
Performance Characteristics:
Analytical performance:
Precision/Reproducibility:
The precision study was based on CLSI (EP5-A2) Evaluation of Precision Performance of Quantitative Measurement Methods. Precision was initially evaluated using three samples of processed sera pooled with fully preserved citrate beta alanine that together had analyte levels that spanned measuring range of the assays (IgM Kappa 0.2 - 5.0g/L, IgM Lambda: 0.18 - 4.50g/L).
The 21 day precision study was performed by running the sera samples in duplicate (within-run analysis), two runs per day (between-run analysis) over 21 days (between-day) using three reagent lots (Batches 1, 2 and 3) and four instruments (SPAPLUS 2, 5, 7 and 9).
An additional "bridging" precision study was carried out. Precision was evaluated using five samples of pooled native sera that together had analyte levels that spanned the measuring range of the assays (IgM Kappa 0.2 - 5.0g/L, IgM Lambda: 0.18 - 4.50g/L). A summary of the precision samples used are described below:
The 21 day bridging precision study was performed by running the sera samples in duplicate (within-run analysis), two runs per day (between-run analysis) over 21 days (between-day) using one reagent lot and three instruments (SPAPLUS 1, 9 and 12).
Repeatability
Initial IgM Kappa (Data present in IFU):
| Sample | N | Mean | Within Run | | Between run | | Between day | | Total | | Pass? (CV