(29 days)
For in vitro diagnostic use in the control of ADVIA Chemistry systems for certain chemistry methods.
The Bayer Special Chemistry Controls are two separate levels of quality control material prepared from human serum with nonserum constituents added. All the analytes currently in the control material are: Acid Phosphatase Lactate Pancreatic Amylase Lipase Cholinesterase The intention of this submission is to add the assigned values to the labeling claims for: Cholinesterase
This document is a 510(k) premarket notification for a quality control material and does not describe a study with acceptance criteria and device performance in the way typically associated with AI/ML medical devices.
Instead, it's a submission for an in vitro diagnostic device (IVD), specifically a quality control material called "Special Chemistry Control." The "performance" being described is the control's suitability for monitoring precision and accuracy of certain chemistry test procedures. The primary focus of this submission is to add assigned values for a new analyte (Cholinesterase) to the labeling claims of an existing, already cleared device.
Therefore, most of the questions you've asked about acceptance criteria, study design, sample sizes, ground truth, experts, and MRMC studies for AI/ML devices are not applicable to this type of submission.
Here's an attempt to answer the relevant parts based on the provided text, and explain why other parts are not applicable:
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A table of acceptance criteria and the reported device performance
This document does not provide a table of acceptance criteria and reported device performance in the context of diagnostic accuracy (e.g., sensitivity, specificity for a disease). The "device performance" in this context refers to its ability to serve as an accurate control for an analyzer.
The key "performance" aspect mentioned is the addition of assigned values for Cholinesterase to the labeling claims. This implies that the manufacturer performed internal validation to establish these assigned values, ensuring they are appropriate for controlling an ADVIA Chemistry analyzer. However, the specific acceptance criteria (e.g., within X% of a reference method, or within a certain coefficient of variation) and the results of that validation are not detailed in this summary. The FDA's acceptance is based on the substantial equivalence to a predicate device and the suitability of the control material, including its analytically derived assigned values.
Not Available in the document: Specific quantitative acceptance criteria or detailed performance data for the Cholinesterase assay within the control. The approval is based on the premise that the product is a control material and the method for determining its assigned values is sound, and it's substantially equivalent to a previously cleared control.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not Applicable / Not Available: This document does not describe a clinical study with a "test set" of patient data. The "testing" done would have been laboratory-based analytical validation to determine the assigned values for Cholinesterase within the control material. Details on the number of runs, replicates, or lots used to establish these values are not provided in this summary. The data provenance would be from Bayer's internal laboratories or a contract manufacturer (Randox Laboratories in the UK).
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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 / Not Available: "Ground truth" in the diagnostic sense is not being established here. The "ground truth" for a quality control material is its analytically determined concentration for a given analyte. This is typically established through rigorous laboratory methods, often using reference methods or multiple assays, not by expert consensus in the clinical sense.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable: This is irrelevant for a quality control material submission.
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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 submission is for a quality control material, not an AI-powered diagnostic device. No MRMC study was performed.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not Applicable: This is not an algorithm or AI device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for a quality control material is its analytically determined concentration/activity for each analyte. This is established by the manufacturer using validated laboratory methods, often involving comparison to reference materials or methods, and robust statistical analysis of multiple measurements. This is not expert consensus, pathology, or outcomes data.
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The sample size for the training set
Not Applicable / Not Available: There is no "training set" in the context of machine learning. If we interpret "training set" very broadly as the data used to establish the assigned values for the control, the specific sample sizes (e.g., number of replicates, number of lots) for this analytical validation are not provided in this document.
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How the ground truth for the training set was established
Not Applicable / Not Available: The "ground truth" (assigned values) for the Cholinesterase in the control material would have been established through a manufacturing process's analytical validation. This involves:
- Careful formulation of the control material.
- Multiple analyses of the control material using highly precise and accurate methods (often the same ADVIA Chemistry analyzers or reference methods).
- Statistical determination of the mean or target value and its acceptable range.
- This is an internal process by the manufacturer based on analytical chemistry principles, not clinical expert review.
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JUN 2 5 2003
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: K031644
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
Randox Laboratories 55 Diamond Road Crumlin, County Antrim, UK Establishment Registration: 8020890
Device Name:
Special Chemistry Control
Proprietary/Trade Name
Common Name: Classification Name: Bayer ADVIA Chemistry Special Chemistry Control Quality Control Material Enzyme Controls (assayed and unassaved)
Classification: Class I Regulation Number: 21 CFR 862.1660 Panel: Chemistry (75) Product Code: JJY Predicate Device: Bayer Special Chemistry Control Premarket Notification Number: K030801
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Device Description:
The Bayer Special Chemistry Controls are two separate levels of quality control material prepared from human serum with nonserum constituents added.
All the analytes currently in the control material are: Acid Phosphatase Lactate Pancreatic Amylase Lipase Cholinesterase
The intention of this submission is to add the assigned values to the labeling claims for: Cholinesterase
Intended Use:
The Special Chemistry Controls are assayed control materials for in vitro diagnostic use to monitor the precision and accuracy of certain chemistry test procedures for the ADVIA Chemistry analyzers.
Substantial Equivalence:
The Special Chemistry Controls are identical in intended use, storage and handling, stability, source material (human serum), and instructions for use as the previously cleared Special Chemistry Controls. The only difference in these controls is the addition of the assigned values in the labeling of a new analyte: Cholinesterase.
As with the predicate device, the control materials are lyophilized and require reconstitution with 5.0 mL distilled water. These controls are only for use on the Bayer Chemistry Analyzers.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 2 5 2003
Mr. Andres Holle Manager, Regulatory Affairs Bayer HealthCare LLC Diagnostics Division 511 Benedict Avenue Tarrytown, NY 10591-5097
K031644 Re:
Trade/Device Name: Special Chemistry Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: May 22, 2003 Received: May 29, 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 (OS) 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,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director 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): ____________________________________________________________________________________________________________________________________________________
Device Name: Special Chemistry Control
Indications for Use:
For in vitro diagnostic use in the control of ADVIA Chemistry systems for certain chemistry methods.
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Concurrence of CDRH, Office of Device Evaluation
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Office of In Vitro Diagnostic Device Evaluation and Safety
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§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.