(424 days)
This kit is intended for the quantitative in vitro determination of human IgA in serum, lithium heparin or EDTA plasma using the Binding Site SPAPLUS turbidimetric analyser. Measurement of IgA aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. The test results are to be used in conjunction with other clinical and laboratory findings.
The Binding Site Human IgA Liquid Reagent Kit for use on the SPAPLUS is an immunoturbidimetric assy. Anti-IgA antibodies react with antigen in the sample to form antigen/antibody complex which is measured turbidimetrically.
The provided text describes a 510(k) summary for the Human IgA Liquid Reagent Kit for use on the SPAPLUS, but it does not contain a study proving the device meets specific acceptance criteria in the format requested. The document is an FDA submission for substantial equivalence to a predicate device, focusing on product description, intended use, and variations from the predicate.
Therefore, many of the requested data points (like sample size, ground truth, expert qualifications, adjudication methods, or MRMC studies) are not present in the provided text, as they are typically associated with performance studies rather than substantial equivalence claims based on a comparison to an existing product.
However, I can extract the acceptance criteria as implied by the comparison to the predicate device and the modifications described. The 'reported device performance' is inferred from the modifications section, rather than explicit numerical results from a study.
Here's the information that can be extracted or inferred from the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the claim of substantial equivalence to the predicate device and the improvements made. The "reported device performance" is the specifications of the modified device.
| Acceptance Criteria (Implied from Predicate/Improvements) | Reported Device Performance (Modified Device Specifications) |
|---|---|
| Intended Use: Same as predicate | Same |
| Method: Immunoturbidimetric assay | Same |
| Sample Type: Serum, Plasma (Heparin and EDTA) | Same |
| Measuring range: Comparable or improved | 0.02-28g/L (with rerun at neat sample dilution), including an additional low-level range of 0.02-0.7g/L |
| Antigen excess capacity: Comparable or improved | 40g/L |
Study Details (Based on provided text)
- Sample size used for the test set and the data provenance: Not mentioned. The document primarily focuses on a comparison to a predicate device and modifications, not a new clinical performance study with a test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an in vitro diagnostic (IVD) kit, not an AI-assisted diagnostic tool that would involve human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is an IVD kit, not a standalone algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned. For an IVD kit, ground truth would typically come from a reference method.
- The sample size for the training set: Not applicable/Not mentioned. The document describes an immunoturbidimetric assay, which is a chemical reaction-based test, not a machine learning algorithm requiring a training set.
- How the ground truth for the training set was established: Not applicable/Not mentioned. As above, this is not a machine learning device.
Additional Information from the document:
- Predicate Device: Roche IgA Tina Quant Gen 2. on the Modular P (K040435).
- Modifications mentioned:
- Added a low-level range (0.02-0.7g/L) for immunodeficiency determination, as recommended by ESID guidelines (below 0.2g/L, optimally down to 0.07g/L).
- Sample volume changed from 25 µL to 8µL to allow neat sample runs.
- Antigen excess capacity improved to 40g/L (from 30g/L in predicate).
- Fundamental scientific technology: Unchanged.
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Page 1 of 2 Date prepared 02 November 2010
510 (k) Summary- Human IgA Liquid Reagent Kit for use on the SPAPLUS
According to the requirements of 21·CFR 807.92, the following Introduction information provides sufficient detail to understand the basis for a determination of substantial equivalence.
Human IgA Liquid Reagent Kit for use on the SPAPLUS Proprietary name: IgA antigen, antiserum and control Classification name:
Submitter
The Binding Site P.O Box 11712 Birmingham B14 4ZB Tel: +44 (0)121436 1000 Suzanne Horne
Contact
The Binding Site Human IgA Liquid Reagent Kit for use on the Device description: SPAPLUS is an immunoturbidimetric assy. Anti-IgA antibodies react with antigen in the sample to form antigen/antibody complex which is measured turbidimetrically.
Intended Use:
The kit is intended for the quantitative in vitro determination of human IgA in serum, lithium heparin or EDTA plasma using the Binding Site SPAPLUS turbidimetric analyser.
8 2 7 2012
Predicate device
We claim substantial equivalence to the Roche IgA Tina Quant Gen 2. on the Modular P( K040435) which measures low level IgA.
Similarities and differences to the predicate device
| Topic | Predicate Device (K040435) | Modified Device |
|---|---|---|
| IntendedUse | The kit is intended for thequantitative determination of humanIgA in serum and plasma using aturbidimetric analyser. | Same |
| Method | Immunoturbidimetric assay | Same |
| Sampletype | SerumPlasma - Heparin and EDTA | Same |
| Measuringrange | 0.05-45.0g/L (with extended rerun) | 0.02-28g/L (with rerun at neat sampledilution) |
| Antigenexcess | 30g/L | 40g/L |
The fundamental scientific technology of the modified product is unchanged.
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Page 2 of 2
・ ﺳﺮﯾ
Date prepared 02 November 2010
Modifications
- An additional low level range at a neat sample dilution (0.02- 0.7g/L) has been . added to allow samples to be measured below 0.2g/L because the European Society for Immunodeficiencies (ESID) guidelines recommend that samples should be measured down to at least 0.07g/L in order to determine immunodeficiency. (ESID - European Society for Immunodeficiencies)
- The sample volume has changed from 25 µL to 8µL to allow the sample to be run . at neat
- The antigen excess capacity of the kit has been improved to 40g/L. .
The package insert has been updated to include the kit modifications.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
The Binding Site c/o Ms. Suzanne Horne Regulatory Affairs P.O. Box 11712 Birmingham, Westlands, B14 4ZB, UK
FEB 2 7 2012
Re: K103824
Trade/Device Name: Human IgA Liquid reagent kit for use on SPAPlus™ Regulation Number: 21 CFR §866.5510 Regulation Name: Immunoglobulins A, G, M, D, E immunological test system Regulatory Class: Class II Product Code: CFN Dated: December 10, 2011 Received: January 23, 2012
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 for associated in the 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). und Cosmetic Fee (110) that the device, subject to the general controls provisions of the Act. The I ou may, merelere, mains of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, additional controls. Extraing major 1991. 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 I that FDA has made a determination that your device complies with other requirements of the Act that I DA has made a acted regulations administered by other Federal agencies. You must of any I coclar surated and regeranents, including, but not limited to: registration and listing (21 Colliply with an the Fict of required 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practices and medical device-lefated develop evelity systems (OS) regulation (21 CFR Part 820). This letter requirements as set form in the quars) adevice as described in your Section 510(k) premarket win anow you to ogin marketing of substantial equivalence of your device to a legally marketed
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Page 2 - Ms. Suzanne Horne
predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
of
Reena Philip
Maria Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K/03824
Device Name: Human IgA liquid reagent kit for use on the SPAPLUS
Indications for Use: This kit is intended for the quantitative in vitro determination of human IgA in serum, lithium heparin or EDTA plasma using the Binding Site SPAPLUS turbidimetric analyser. Measurement of IgA aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. The test results are to be used in conjunction with other clinical and laboratory findings.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
hm
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)/03824
Page 1 of 1
§ 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).