(71 days)
No
The summary describes a laboratory assay kit and an analyzer for measuring IgM in CSF. There is no mention of AI or ML in the device description, intended use, or performance studies. The analysis is based on standard laboratory techniques and statistical analysis of results.
No
The device is intended for quantitative in vitro measurement of IgM in cerebrospinal fluid samples, which is a diagnostic purpose, not therapeutic.
Yes
The Optilite IgM CSF Kit is intended for the quantitative in vitro measurement of IgM in cerebrospinal fluid (CSF) samples, which is a diagnostic measurement. The "Summary of Performance Studies" also discusses "Method comparison with predicate device", indicating its use in diagnosing.
No
The device description explicitly lists reagents (Latex Reagent, Calibrator and Controls, Reaction Buffer) which are physical components, not software.
Based on the provided information, the Optilite IgM CSF Kit is indeed an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" explicitly states it is for "quantitative in vitro measurement of IgM in cerebrospinal fluid (CSF) samples". The term "in vitro" is a key indicator of an IVD.
- Device Description: It describes reagents used to perform a test on a biological sample (CSF) outside of the body.
- Anatomical Site: It specifies the sample type is from a human (cerebrospinal fluid).
- Performance Studies: The description of performance studies (Precision, Linearity, Detection limit, Analytical specificity, Method comparison) are typical evaluations performed for IVD devices to demonstrate their analytical performance.
- Predicate Device: The mention of a "Predicate Device" (K120750 Human IgM CSF Kit for use on SPAPLUS) is a strong indicator that this device is being submitted for regulatory clearance as an IVD, often through the 510(k) pathway which requires comparison to a legally marketed predicate device.
Therefore, all the provided information points to the Optilite IgM CSF Kit being an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Optilite IgM CSF Kit is intended for the quantitative in vitro measurement of IgM in cerebrospinal fluid (CSF) samples using the Optilite analyser.
Product codes (comma separated list FDA assigned to the subject device)
CFN
Device Description
The Optilite IgM CSF Kit comprises the following reagents: Latex Reagent: Supplied in stabilised liquid form. Preservatives: 0.025% sodium azide, 0.1% E-amino-n-caproic acid (EACA) and 0.01% benzamidine, 0.05% ProClin. 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. The concentration given on the quality control certificate has been obtained by comparison with the DA470k international reference material. Reaction Buffer: Containing 0.099% sodium azide as a preservative.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cerebrospinal fluid (CSF)
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)
Precision/Reproducibility: The studies were based on CLSI EP5-A2, where 4 sample preparations were tested in 2 runs per day (each of the 2 runs in duplicate) over 5 days using 3 analysers. Acceptance criteria were total precision (%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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 28, 2019
The Binding Site Group Ltd. Kanika Darbar Regulatory Affairs Officer The Binding Site Group Ltd. 8 Calthorpe Road Edgbaston Birmingham. West Midlands, B15 1QT, UK
Re: K190686
Trade/Device Name: Optilite IgM CSF Kit Regulation Number: 21 CFR 866.5510 Regulation Name: Immunoglobulins A, G, M, D, and E immunological test system Regulatory Class: Class II Product Code: CFN Dated: March 8, 2019 Received: March 18, 2019
Dear Kanika Darbar:
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
1
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 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.htm); 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,
Doug Jeffery, Ph.D. Deputy Division Director Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K190686
Device Name Optilite IgM CSF Kit
Indications for Use (Describe)
The Optilite IgM CSF Kit is intended for the quantitative in vitro measurement of IgM in cerebrospinal fluid (CSF) samples using the Optilite analyser.
Type of Use (Select one or both, as applicable)
|X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Optilite IgM CSF Kit 510(k) Submission Summary
Kanika Darbar Regulatory Affairs Officer The Binding Site Group Ltd. 8 Calthorpe Road Edgbaston Birmingham, West Midlands, B15 1QT, UK Telephone: +44 (0)121 456 9500 Email: kanika.darbar@bindingsite.com or regulatory.submissions@bindingsite.com Preparation Date: 28-May-2019
A. 510(k) Number:
B. Purpose for Submission:
New device
C. Measurand:
lgM
D. Type of Test: Quantitative immunoturbidimetry
E. Applicant:
The Binding Site
F. Proprietary and Established Names: Optilite® IgM CSF Kit
G. Regulatory Information:
-
- Regulation section: 21 CFR 866.5510, Immunoglobulins A, G, M, D, and E immunological test system
-
- Classification: Class II
-
- Product code: CFN - method, nephelometric, immunoglobulins (G, A, M)
-
- Panel: Immunology (82)
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H. Intended use:
1. Intended use(s):
The Optilite IgM CSF Kit is intended for the quantitative in vitro measurement of IgM in cerebrospinal fluid (CSF) samples using the Optilite analyser.
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)
I. Device Description:
The Optilite IgM CSF Kit comprises the following reagents:
Latex Reagent: Supplied in stabilised liquid form. Preservatives: 0.025% sodium azide, 0.1% E-amino-n-caproic acid (EACA) and 0.01% benzamidine, 0.05% ProClin.
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. The concentration given on the quality control certificate has been obtained by comparison with the DA470k international reference material.
Reaction Buffer: Containing 0.099% sodium azide as a preservative.
J. Substantial equivalence information:
1. Predicate device name(s) and 510(k) number(s):
Human IgM CSF Kit for use on SPAPLUS K120750
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2. Comparison with predicate:
| Similarities | ||
|---|---|---|
| Item | Test device | Predicate |
| Assay type | Quantitative | Same |
| Specimen Type | CSF | Same |
| Antibody | Sheep anti-human-IgM | Same |
| Intended use | Quantitative in vitro measurement of IgM in cerebrospinal fluid | Same |
| Calibration | Traceable to DA470k | Same |
| On-board | ||
| stability | 30 days | Same |
| Reference | ||
| Interval |