(71 days)
For in vitro diagnostic use in the calibration of the ADVIA 1650 Technicon RA-500, Technicon RA-1000, Technicon RA-XT, Technicon RA-2000, opeRA chemistry systems specific protein methods.
The Bayer Specific Protein Reference Serum are for one absolute value of calibrator material prepared in human serum with nonserum constituents added.
All the analytes currently in the calibrator material are: C4 IgA IgG IgM Transferrin Alpha-1-Acid Glycoprotein Alpha-1-Antitrypsin Haptoglobin
The intention of this submission is to add the assigned values to the labeling claims for use in the US for: Haptoglobin
As with the predicate device, the calibrator materials are a human serum concentrate and dilution is needed with the Specific Protein Sample Diluent provided. These calibrators are for use on the Bayer ADVIA 1650, Technicon RA-1000, Technicon RA-XT, Technicon RA-500, Technicon RA-2000, opeRA chemistry analyzers.
The provided text describes a "Specific Protein Reference Serum" device, which is a calibrator material used for in vitro diagnostic purposes. This type of device does not typically have "acceptance criteria" in the same way that a diagnostic assay or an AI algorithm would. Instead, its regulatory clearance is based on demonstrating "substantial equivalence" to a predicate device.
The document explicitly states:
"The Specific Protein Reference Serum are identical in intended use, storage and handling, stability, source material (human serum), and instructions for use as the previously cleared Specific Protein Reference Serum. The only difference in these calibrators is the addition of the assigned values in the labeling of one new analyte: Haptoglobin."
Therefore, the concept of a study proving the device meets "acceptance criteria" in the context of performance metrics (like sensitivity, specificity, F1 score, etc.) does not apply here. The criteria for acceptance for this calibrator material would revolve around its manufacturing quality, stability, and the accuracy of the assigned Haptoglobin values, which are inherent to its function as a calibrator.
Based on the provided information, I can answer the following points:
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A table of acceptance criteria and the reported device performance: Not applicable. This is a calibrator material, not a diagnostic device with performance metrics like sensitivity or specificity. Its "performance" is its ability to accurately calibrate other devices, which is demonstrated by ensuring the assigned values are correct and stable. The document focuses on substantial equivalence rather than performance against a set of predefined acceptance criteria in the context of diagnostic accuracy.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a calibrator material. There is no "test set" in the sense of patient data for evaluating diagnostic performance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. Ground truth for a calibrator material would involve highly controlled laboratory methods for assaying the concentration of the analytes (Haptoglobin in this case). This is not typically established by clinical experts in the same way as diagnostic imaging or pathology.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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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 is not an AI-assisted device or a diagnostic device requiring human reader interpretation.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a chemical calibrator, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the Haptoglobin values added to the calibrator, the "ground truth" would be established through robust analytical validation studies, likely using reference methods and highly accurate laboratory measurements to determine the precise concentration of Haptoglobin in the calibrator material. This is an analytical "ground truth," not a clinical one.
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The sample size for the training set: Not applicable. Calibrator materials do not have "training sets" in the context of machine learning.
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How the ground truth for the training set was established: Not applicable.
In summary, the provided document is for a medical device (a calibrator material) that is cleared based on "substantial equivalence" to a predicate device. The information requested (acceptance criteria, test sets, expert ground truth, MRMC studies, AI performance, etc.) is typically associated with diagnostic devices, particularly those involving image analysis or disease detection algorithms, and is not relevant to this specific product.
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Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) Number is:________________________________________________________________________________________________________________________________________________
Submitter's Name and Address
Bayer Healthcare LLC 511 Benedict Avenue Tarrytown, NY 10591 Establishment Registration Number: 2432235
Contact Person: Andres Holle Telephone: 914-524-3494 Fax: 914-524-2500 e-mail: andres.holle.b@bayer.com
Contract Manufacturer
Fisher Diagnostics 8365 Valley Pike Middletown, VA 22645-0307 Establishment Registration: 1181121
| Device Name: | Specific Protein Reference Serum |
|---|---|
| Proprietary/Trade Name | Specific Protein Reference Serum |
| Common Name: | Calibrator Material |
| Classification Name: | Calibrator |
| Classification: | Class II |
| Regulation Number: | 21 CFR 862.1150 |
| Panel: | Chemistry (75) |
| Product Code: | JIX |
| Predicate Device: | Specific Protein Reference SerumPremarket Notification Number: K833402 |
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Device Description:
The Bayer Specific Protein Reference Serum are for one absolute value of calibrator material prepared in human serum with nonserum constituents added.
All the analytes currently in the calibrator material are: ੍ਰਤ C4 IgA IgG IgM Transferrin Alpha-1-Acid Glycoprotein Alpha-1-Antitrypsin Haptoglobin
The intention of this submission is to add the assigned values to the labeling claims for use in the US for: Haptoglobin
Intended Use:
For in vitro diagnostic use in the calibration of the ADVIA 1650 Technicon RA-500, Technicon RA-1000, Technicon RA-XT, Technicon RA-2000, opeRA chemistry systems specific protein methods.
Substantial Equivalence:
Ceruloplasmin
The Specific Protein Reference Serum are identical in intended use, storage and handling, stability, source material (human serum), and instructions for use as the previously cleared Specific Protein Reference Serum. The only difference in these calibrators is the addition of the assigned values in the labeling of one new analyte: Haptoglobin.
As with the predicate device, the calibrator materials are a human serum concentrate and dilution is needed with the Specific Protein Sample Diluent provided. These calibrators are for use on the Bayer ADVIA 1650, Technicon RA-1000, Technicon RA-XT, Technicon RA-500, Technicon RA-2000, opeRA chemistry analyzers.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. 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 emblem resembling an eagle or bird in flight, composed of three curved lines representing wings and a stylized head and tail.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 1 3 2004
Mr. Andres Holle Manager, regulatory Affairs Bayer Healthcare, LLC Diagnostics Division 511 Benedict Avenue Tarrytown, NY 10591
Re: K033791
Trade/Device Name: Specific Protein Reference Serum Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: November 17, 2003 Received: December 23, 2003
Dear Mr. Holle:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Jean M. Cooper, MS, DVM.
Yean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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| 510(k) Number (if known): | K033991 |
|---|---|
| --------------------------- | --------- |
Device Name: Specific Protein Reference Serum
Indications for Use:
For in vitro diagnostic use in the calibration of the ADVIA 1650 Technicon RA-500, Technicon RA-1000, Technicon RA-XT, Technicon RA-2000, opeRA chemistry systems specific protein methods.
(PLEASE DO NOT WRITE BELOW THIS LINE—CONTINUE ON ANOTHER PAGE, IF NEEDED)
(ODE) Concurrence of CDRH, Office of Device Evaluation
| Prescription Use | ✓ | OR | Over-The-Counter |
|---|---|---|---|
| Use | |||
| (Per 21 CFR 801.109) | (Optional Format | ||
| 1-2-96) |
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K053741
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.