(28 days)
No
The summary describes calibrators and controls for clinical chemistry analyzers, which are standard laboratory reagents. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is described as a calibrator and control for quantitative Roche methods on clinical chemistry analyzers, monitoring accuracy and precision, rather than directly treating or diagnosing a medical condition.
No
The device is described as a calibrator and control for Roche clinical chemistry analyzers, used for quality control and calibration of quantitative methods. It does not diagnose any condition or disease.
No
The device description explicitly states it is a liquid calibrator and control, which are physical substances, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the calibrator and control are "for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers" and "for use in quality control by monitoring accuracy and precision for the quantitative methods". These methods are used to measure substances (Ammonia, Ethanol, CO2) in biological samples (implied by "quantitative Roche methods on Roche clinical chemistry analyzers"). This directly aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The description mentions "buffered aqueous solution" and "adjusted concentrations of the control components are in the normal range for the Normal control and the pathological range for the Abnormal control." This indicates that the device is designed to interact with or be used in conjunction with biological samples or analytical systems that process biological samples.
- Predicate Devices: The mention of predicate devices (K952282 and K951595) which are also named "Ammonia/Ethanol/CO2 Calibrator" and "Ammonia/Ethanol/CO2 Controls" strongly suggests that this device falls within the same regulatory category as its predicates, which are IVDs.
The absence of information about image processing, AI/ML, imaging modality, anatomical site, patient age range, intended user/care setting, training/test sets, performance studies, and key metrics is not unusual for a calibrator or control device. These elements are more commonly found in descriptions of diagnostic tests themselves, rather than the materials used to calibrate and control those tests.
Therefore, the primary function of calibrating and controlling quantitative methods used on clinical chemistry analyzers to measure substances in biological samples firmly places this device in the IVD category.
N/A
Intended Use / 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.
Product codes
JIX, JJY
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
JUL 1 6 2003
510(k) Summary - Ammonia/Ethanol/CO2 Calibrator and Controls
. *
| Introduction | According to the requirements of 21 CFR 807.92, the following information
provides sufficient detail to understand the basis for a determination of
substantial equivalence |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter
name, address,
contact | Roche Diagnostics Corporation
9115 Hague Rd
Indianapolis IN 46250
(317) 521-3831
Contact person: Sherri L. Coenen
Date 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 Abnormal
Common name: Ammonia/Ethanol/CO2 Calibrator and Controls
Classification name:
• Calibrator, Multi-analyte mixture
• Multi-analyte controls, all kinds (assayed and unassayed) |
| Device
description | 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. |
:
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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).
2
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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Page 2 -
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 |
|---|---|
| -------- | --------- |
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