(70 days)
Not Found
No
The summary describes a standard in vitro diagnostic (IVD) kit for measuring IgA in CSF using a specific analyzer. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the device description, intended use, or performance studies. The performance studies focus on standard analytical validation metrics for IVD assays.
No.
This device is an in vitro diagnostic (IVD) kit intended for quantitative measurement of IgA in cerebrospinal fluid, which is used for diagnosis or monitoring purposes, not for treating a condition.
Yes
The device quantitatively measures IgA in cerebrospinal fluid, which is used to provide information to aid in diagnosis or monitoring of conditions.
No
The device is an in vitro diagnostic (IVD) kit consisting of reagents (Latex Reagent, Calibrator and Controls, and Reaction Buffer) used with an analyzer. It is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states it is for "quantitative in vitro measurement of IgA in cerebrospinal fluid (CSF)". The term "in vitro" is a key indicator of an IVD.
- Device Description: The description lists reagents (Latex Reagent, Calibrator and Controls, and Reaction Buffer), which are typical components of IVD kits used for laboratory testing.
- Anatomical Site: It specifies "Cerebrospinal fluid (CSF)", which is a biological sample tested outside the body.
- Intended User / Care Setting: It mentions "Prescription use only" and "clinical laboratory professional in a clinical laboratory setting," which aligns with the typical use of IVDs.
- Performance Studies: The description of performance studies (Precision/Reproducibility, Linearity, Detection limit, Analytical specificity, Method comparison) are standard types of studies conducted to validate the performance of IVD devices.
- Predicate Device: The mention of a "Predicate Device" with a K number (K993549) is a strong indication that this device is being submitted for regulatory clearance as an IVD, as predicate devices are used for comparison in the regulatory process for IVDs.
All of these factors collectively confirm that the Optilite IgA CSF Kit is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Optilite IgA CSF Kit is intended for the quantitative in vitro measurement of IgA in cerebrospinal fluid (CSF) using the Optilite analyser.
Product codes (comma separated list FDA assigned to the subject device)
CFN
Device Description
The Optilite IgA 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)
1. Analytical performance:
-
Precision/Reproducibility: A precision study (based on CLSI EP5-A2) was performed over 5 working days, with 2 runs per day. Two users assessed 4 different samples, using 2 reagent lots each on 3 analysers.
- Results:
Precision Summary Mean mg/L SD CV % SD CV % SD CV % SD CV % Level 1 2.24 0.03 1.3 0.04 1.9 0.07 3.3 0.09 4.0 Level 2 3.53 0.09 2.5 0.08 2.3 0.16 4.4 0.20 5.6 Level 3 4.59 0.04 0.8 0.05 1.1 0.20 4.2 0.20 4.4 Level 4 28.90 0.48 1.7 0.56 1.9 0.40 1.4 0.84 2.9
- Results:
-
Linearity/assay reportable range: A linearity study was performed following CLSI EP6-A. The linearity was confirmed using a serially diluted sample over the range of 1.0-44.8mg/L with deviation from linearity
§ 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).
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January 23, 2019
The Binding Site Group, Ltd. Natasha Verhaak Regulatory Affairs Officer 8 Calthorpe Road Birmingham, West Midlands, B15 1QT, UK
Re: K183151
Trade/Device Name: Optilite IgA 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: November 6, 2018 Received: November 14, 2018
Dear Natasha Verhaak:
We have reviewed vour 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
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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,
Leonthena R. Carrington -S
Lea Carrington 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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K183151
Device Name Optilite IgA CSF Kit
Indications for Use (Describe)
The Optilite IgA CSF Kit is intended for the quantitative in viro measurement of I.A. in cerebrospinal fluid (CSF) 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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Optilite IgA CSF Kit 510(k) Submission Summary
Natasha Verhaak 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: natasha.verhaak@bindingsite.com or regulatory.submissions@bindingsite.com
A. 510(k) Number:
B. Purpose for Submission:
New device
C. Measurand:
lgA
D. Type of Test: Quantitative immunoturbidimetry
E. Applicant:
The Binding Site
F. Proprietary and Established Names: Optilite® IgA 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 IgA CSF Kit is intended for the quantitative in vitro measurement of IgA in cerebrospinal fluid (CSF) 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 IgA 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:
-
- Predicate device name(s) and 510(k) number(s): Beckman Coulter Low Concentration Immunoglobulin A (IGALC) reagent and Cerebrospinal Fluid Protein Calibrator (CSF CAL) (K993549)
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| Similarities | ||
|---|---|---|
| Item | Test device | Predicate |
| Intended use | In vitro quantification of IgA in | |
| CSF. | In vitro quantification of IgA in | |
| CSF (also serum). | ||
| Analyte | IgA | Same |
| Traceability | DA470k | Same |
| Reagent type | Latex enhanced | Same |
| Reference interval |