(265 days)
No
The summary describes a traditional in vitro diagnostic (IVD) kit for measuring rheumatoid factor using a specific analyzer. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The performance studies are standard for IVD assays.
No.
The device is an in vitro diagnostic (IVD) kit used for the quantitative measurement of rheumatoid factor, which aids in the diagnosis of a condition, rather than treating or preventing it.
Yes
The device aids in the diagnosis of rheumatoid arthritis by providing quantitative measurements of rheumatoid factor in serum.
No
The device description explicitly states it comprises reagents (Reaction Buffer, Latex Reagent, RF Controls, RF Calibrator), which are physical components, not software.
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 kit is for the "quantitative in vitro measurement of rheumatoid factor in serum". The term "in vitro" means "in glass" or "outside of a living organism," which is a key characteristic of IVDs.
- Purpose: The intended use also states that the measurement "may aid in the diagnosis of rheumatoid arthritis." IVDs are used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of disease.
- Device Description: The description lists reagents used to perform a test on a biological sample (serum).
- Performance Studies: The document describes analytical performance studies conducted on the device, which are typical for IVDs to demonstrate their reliability and accuracy.
N/A
Intended Use / Indications for Use
The Optilite Rheumatoid Factor (RF) Kit is intended for the quantitative in vitro measurement of rheumatoid factor in serum using the Binding Site Optilite analyser. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis. This test should be used in conjunction with other laboratory and clinical findings.
Product codes (comma separated list FDA assigned to the subject device)
DHR
Device Description
The Optilite Rheumatoid Factor Kit comprises the following reagents:
Reaction Buffer: Containing Glycine Buffer pH 8.3, Sodium Chloride, Sodium Ethylenediamine tetra acetic acid disodium salt dehydrate, Bovine serum albumin, Sodium Azide 0.09% w/v
Latex Reagent: Containing Glycine Buffer pH 7.3, Sodium Chloride, Latex particle adsorbed human IqG. Sodium Azide 0.09% w/v.
RF Controls: Supplied at 2 levels, Low and High. Target values and ranges are supplied in the Quality Control certificate. Supplied ready for use.
RF Calibrator: Calibration has been carried out and value has been assigned using an immunoturbidimetric method standardised to the International Reference Preparation, WHO Standard 64/2. Supplied ready for use.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Analytical performance:
Precision/Reproducibility: A study based on CLSI EP5-A2 tested 5 sample preparations in 2 runs per day (each of the 2 runs in duplicate) over 21 days using 3 analysers. Acceptance criteria were total precision (%CV
§ 866.5775 Rheumatoid factor immunological test system.
(a)
Identification. A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 3, 2017
The Binding Site Group Ltd. Mr. Jon Lauder Regulatory Affairs Specialist 8 Calthorpe Road Edgbaston Birmingham, West Midlands B15 1QT UK
Re: K162263
Trade/Device Name: Optilite® Rheumatoid Factor Kit Regulation Number: 21 CFR 866.5775 Regulation Name: Rheumatoid factor immunological test system Regulatory Class: II Product Code: DHR Dated: April 6, 2017 Received: April 7, 2017
Dear Mr. Lauder:
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/Resourcesfor You/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 yours,
Kelly Oliner -S
For
Leonthena Carrington, MBA, MS, MT(ASCP) Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Optilite Rheumatoid Factor Kit
Indications for Use (Describe)
The Optilite Rheumatoid Factor (RF) Kit is intended for the quantitative in vitro measurement of rheumatoid factor in serum using the Binding Site Optilite analyser. Measurement of rheumatoid factor may aid in the diagnosis of theumatoid arthritis. This test should be used 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) |
|---|---|
| ----------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------- |
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Optilite Rheumatoid Factor Kit 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
Jon Lauder Regulatory Affairs Specialist The Binding Site Group Ltd. 8 Calthorpe Road Edgbaston Birmingham, West Midlands, B15 1QT, UK Telephone: +44 (0)121 456 9500 Email: jon.lauder@bindingsite.co.uk or regulatory.submissions@bindingsite.co.uk
A. 510(k) Number:
B. Purpose for Submission:
New device
C. Measurand:
Rheumatoid Factor
D. Type of Test:
Quantitative immunoturbidimetry
E. Applicant:
The Binding Site
F. Proprietary and Established Names:
Optilite Rheumatoid Factor Kit
G. Regulatory Information:
-
- Regulation section: 21 CFR 866.5775, Rheumatoid factor immunological test system
-
- Classification: Class II
-
- Product code: DHR - system, test, rheumatoid factor
-
- Panel: Immunology (82)
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H. Intended use:
1. Intended use(s):
The Optilite Rheumatoid Factor (RF) Kit is intended for the quantitative in vitro measurement of rheumatoid factor in serum using the Binding Site Optilite analyser. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis. This test should be used in conjunction with other laboratory and clinical findings.
2. Indication(s) for use:
Same as Intended use.
3. Special conditions for use statement(s):
Prescription use only
4. Special instrument requirements:
The Binding Site Optilite turbidimetric analyser (K110035)
l. Device Description:
The Optilite Rheumatoid Factor Kit comprises the following reagents:
Reaction Buffer: Containing Glycine Buffer pH 8.3, Sodium Chloride, Sodium Ethylenediamine tetra acetic acid disodium salt dehydrate, Bovine serum albumin, Sodium Azide 0.09% w/v
Latex Reagent: Containing Glycine Buffer pH 7.3, Sodium Chloride, Latex particle adsorbed human IqG. Sodium Azide 0.09% w/v.
RF Controls: Supplied at 2 levels, Low and High. Target values and ranges are supplied in the Quality Control certificate. Supplied ready for use.
RF Calibrator: Calibration has been carried out and value has been assigned using an immunoturbidimetric method standardised to the International Reference Preparation, WHO Standard 64/2. Supplied ready for use.
J. Substantial equivalence information:
-
- Predicate device name(s) and 510(k) number(s):
Rheumatoid Factor (RF) Kit for use on SPAPLUS; K160070
- Predicate device name(s) and 510(k) number(s):
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| Similarities | ||
|---|---|---|
| Item | Test device | Predicate |
| Assay type | Quantitative | Same |
| Specimen Type | Serum | Same |
| Antibody | Human IgG anti-human-IgM | Same |
| Intended use | Turbidimetric in vitro quantification | |
| of rheumatoid factor | Same | |
| Calibration | WHO 64/2 | Same |
| Reference Interval | 12.5 IU/mL | Same |
| Open Vial Stability | 3 months | 3 months |
| On-board stability | 30 days | 30 days |
| Differences | ||
| Item | Test device | Predicate |
| Measuring range | 7 - 100 IU/mL (1+0) | 10 - 104 IU/mL (1/1) |
| 70 - 1000 IU/mL (1+9) | 70 - 1040 IU/mL (1/100) | |
| Instrument | Binding Site Optilite | Binding Site SPAPLUS |
2. Comparison with predicate:
K. Standards and Guidance documents referenced:
CLSI EP17-A Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline
CLSI EP7-A2 Interference Testing in Clinical Chemistry, Approved Guideline - Second Edition
CLSI EP6-A: Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach
CLSI EP5-A2 Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline - Second Edition
L. Test Principle:
The determination of soluble antigen concentration by turbidimetric methods involves the reaction with specific antiserum to form insoluble complexes. When light is passed through the suspension formed a portion of the light is transmitted and focused onto a photodiode by an optical lens system. The amount of transmitted light is indirectly proportional to the specific protein concentration in the test sample. Concentrations are automatically calculated by reference to a calibration curve stored within the instrument.
M. Performance Characteristics (if/when applicable):
-
- Analytical performance:
- Precision/Reproducibility: a.
The studies were based on CLSI EP5-A2, where 5 sample preparations were tested in 2 runs per day (each of the 2 runs in duplicate) over 21 days using 3 analysers. Acceptance criteria were total precision (%CV