(28 days)
Ammonia/Ethanol/CO2 Calibrator is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet.
Ammonia/Ethanol/CO2 Control is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.
The Ammonia/Ethanol/CO2 Calibrator is a liquid ready-for-use calibrator based on a buffered aqueous solution. The concentration of the calibrator The Ammonia/Ethanol/CO2 Controls are liquid ready-for-use controls based on a buffered aqueous solution. The adjusted concentrations of the control components are in the normal range for the Normal control and the pathological range for the Abnormal control.
This document is a 510(k) summary for a medical device (Ammonia/Ethanol/CO2 Calibrator and Controls) and does not contain information typically found in a study proving a device meets acceptance criteria for an AI or software-based medical device.
The provided text describes a calibrator and controls for in vitro diagnostic devices, which are reagents used to ensure the accuracy and precision of laboratory tests on clinical chemistry analyzers. These are physical products, not software/AI, and therefore the concepts of "acceptance criteria," "device performance," "sample size for test/training sets," "ground truth," "MRMC studies," or "standalone performance" as typically applied to AI/software devices are not directly applicable in the same way.
The document focuses on establishing substantial equivalence to existing legally marketed predicate devices, which is the regulatory pathway for this type of product. Substantial equivalence means the new device is as safe and effective as a legally marketed device that is not subject to PMA (Premarket Approval).
Here's a breakdown of the information in relation to your request, highlighting what's missing due to the nature of the device:
1. Table of Acceptance Criteria and Reported Device Performance:
This type of table is not present in the document because this is not a performance study of an AI/software device. For a calibrator/control, "performance" relates to its ability to accurately and precisely calibrate and control the analytical process of a clinical chemistry analyzer. The document states:
- Intended Use of Calibrator: "for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet."
- Intended Use of Control: "for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet."
The "acceptance criteria" here would generally be related to the stability, homogeneity, and assigned values of the calibrator/control, and their ability to ensure the accuracy of the assay. These details are not within this summary. Substantial equivalence usually means that the new device performs similarly to the predicate in these aspects.
| Acceptance Criteria (Implied for Calibrator/Control) | Reported Device Performance (Implied from substantial equivalence claim) |
|---|---|
| Ability to accurately calibrate quantitative Roche methods | Substantially equivalent to predicate device (K952282) |
| Ability to monitor accuracy and precision for quantitative methods | Substantially equivalent to predicate device (K951595) |
| Performance characteristics (e.g., analyte concentrations, stability) | Equivalent to predicate devices (K952282 and K951595) |
Regarding items 2-9, these are generally not applicable to this type of device and submission:
2. Sample size used for the test set and the data provenance: Not applicable. There's no "test set" in the context of an AI/software algorithm. The device itself is a physical calibrator/control.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/software device is not relevant here. The ground truth for the calibrator/control would be the analytically determined true values of the analytes within the product, established through reference methods or highly accurate assays, not expert consensus on images or similar data.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating human performance with and without AI assistance for tasks like diagnosis or detection.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used: For a calibrator/control, the "ground truth" refers to the assigned values or the true concentrations of the analytes (Ammonia, Ethanol, CO2) within the calibrator and control materials. This is typically established through a rigorous analytical process using reference methods and highly accurate instrumentation, not expert consensus, pathology, or outcomes data in the way these terms are used for AI/software devices.
8. The sample size for the training set: Not applicable. No training set for an AI/software algorithm.
9. How the ground truth for the training set was established: Not applicable.
Summary of what's provided for this type of device and submission:
- Device Name: Ammonia/Ethanol/CO2 Calibrator and Controls
- Intended Use: Calibration and quality control for quantitative Roche methods on Roche clinical chemistry analyzers.
- Predicate Device:
- Regulatory Conclusion: Substantial Equivalence to the predicate devices. This means the FDA has determined the new device is as safe and effective as the existing marketed devices. The "study that proves the device meets the acceptance criteria" in this context is the evidence presented by the manufacturer to the FDA demonstrating this substantial equivalence, which would include data on the formulation, stability, and characterization of the calibrator and controls, demonstrating they perform comparably to the predicate. These detailed data points are not typically included in the 510(k) Summary, but rather in the full 510(k) submission.
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JUL 1 6 2003
510(k) Summary - Ammonia/Ethanol/CO2 Calibrator and Controls
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| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence |
|---|---|
| Submittername, address,contact | Roche Diagnostics Corporation9115 Hague RdIndianapolis IN 46250(317) 521-3831Contact person: Sherri L. CoenenDate prepared: June 13, 2003 |
| Device Name | Proprietary name:• Roche Diagnostics Ammonia/Ethanol/CO2 Calibrator• Roche Diagnostics Ammonia/Ethanol/CO2 Control Normal• Roche Diagnostics Ammonia/Ethanol/CO2 Control AbnormalCommon name: Ammonia/Ethanol/CO2 Calibrator and ControlsClassification name:• Calibrator, Multi-analyte mixture• Multi-analyte controls, all kinds (assayed and unassayed) |
| Devicedescription | The Ammonia/Ethanol/CO2 Calibrator is a liquid ready-for-use calibratorbased on a buffered aqueous solution. The concentration of the calibratorThe Ammonia/Ethanol/CO2 Controls are liquid ready-for-use controls based on a buffered aqueous solution. The adjusted concentrations of the control components are in the normal range for the Normal control and the pathological range for the Abnormal control. |
:
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510(k) Summary - Ammonia/Ethanol/CO2 Calibrator and Controls, continued
Intended use
Ammonia/Ethanol/CO2 Calibrator is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet.
Ammonia/Ethanol/CO2 Control is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.
Predicate Device
We claim substantial equivalence to the currently marketed Ammonia/Ethanol/CO2 Calibrator (K952282) and Ammonia/Ethanol/CO2 Controls (K951595).
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The eagle is facing to the right. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 16 2003
Ms. Sherri L. Coenen MT(ASCP) Regulatory Affairs Consultant Regulatory Submissions, Centralized Diagnostics Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457
Re: K031880
Trade/Device Name: Ammonia/Ethanol/CO2 Calibrator and Controls Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX; JJY Dated: June 13, 2003 Received: June 18, 2003
Dear Ms. Coenen:
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,
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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Indications for Use Statement
510(k) Number (if known): N/A
Device Name: Ammonia/Ethanol/CO2 Calibrator and Controls
Indications For Use:
Ammonia/Ethanol/CO2 Calibrator is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet.
Ammonia/Ethanol/CO2 Control is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Prescription Use | ✓ |
|---|---|
| (Per 21 CFR 801.109) | |
| Concurrence of CDRH, Office of Device Evaluation (ODE) OR Over-The-Counter Use |
(Optional Format 1-2-96)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
| 510(k) | K031880 |
|---|---|
| -------- | --------- |
22
§ 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.