(200 days)
The Oxalate Normal and Elevated Controls are for use in the quality control of the Thermo Oxalate method for the quantitative determination of urine oxalate. The control is used for monitoring accuracy and precision on automated clinical chemistry analysers and for manual operations. It is for in vitro diagnostic use only.
The Oxalate Standard is intended for the calibration of Oxalate assays using the Thermo Oxalate Reagent. It is for in vitro diagnostic use only.
Not Found
This FDA 510(k) summary document describes Oxalate Urine Controls (Normal & Elevated) and Oxalate Standard, which are calibrators and controls for an existing oxalate assay. This type of device does not typically involve the kind of "AI model performance" described in your request (e.g., test sets, ground truth, experts, MRMC studies, standalone performance).
Instead, "acceptance criteria" and "device performance" for these types of in vitro diagnostic (IVD) devices relate to their analytical performance (e.g., accuracy, precision, linearity, stability) in conjunction with the assay they are designed to control or calibrate. The "study that proves the device meets acceptance criteria" would typically be validation studies demonstrating these analytical characteristics.
Therefore, many of the requested fields are not applicable to the information provided in this document. I will fill in what can be inferred or is directly stated, and mark as "N/A" (Not Applicable) where the information is not relevant to this type of device or not present in the provided text.
Acceptance Criteria and Study for Oxalate Urine Controls and Oxalate Standard
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Typically established by manufacturer) | Reported Device Performance (Summary from validation study) |
|---|---|---|
| Accuracy (Controls) | Not explicitly stated in this document. Typically assessed against target values. | Not explicitly stated in this document. Implied by substantial equivalence to predicate. |
| Precision (Controls) | Not explicitly stated in this document. Typically expressed as %CV. | Not explicitly stated in this document. Implied by substantial equivalence to predicate. |
| Calibration Performance (Standard) | Not explicitly stated in this document. Typically assessed by recovery, linearity. | Not explicitly stated in this document. Implied by substantial equivalence to predicate. |
| Stability | Not explicitly stated in this document. Typically shelf-life and in-use stability. | Not explicitly stated in this document. Implied by substantial equivalence to predicate. |
| Substantial Equivalence | Device is substantially equivalent to a legally marketed predicate device. | Device is found substantially equivalent to a predicate device for the stated indications for use (K062521). |
2. Sample size used for the test set and the data provenance
- Sample Size: N/A (Analytical performance studies for calibrators/controls don't typically refer to "test sets" in the same way an AI model does. Instead, they involve multiple runs, replicates, and lots of control/calibrator material.)
- Data Provenance: N/A (Not specified in this document. Typically, validation studies are performed internally by the manufacturer.)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A (Ground truth for calibrators/controls is established through gravimetric/volumetric preparation, analytical assays, and certified reference materials, not expert consensus on images or similar data.)
4. Adjudication method for the test set
- N/A (Not relevant for this type of device.)
5. 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
- N/A (This is not an AI-assisted diagnostic device. It is a control/calibrator for a laboratory assay.)
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- N/A (Not an AI algorithm. Its performance is evaluated analytically, not in a diagnostic "standalone" manner.)
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For calibrators and controls, the "ground truth" (or target value) is established through precise manufacturing, gravimetric/volumetric preparation, and often verification against higher-order reference materials or methods. The document does not specify the exact methods used to assign target values to the controls or to determine the concentration of the standard.
8. The sample size for the training set
- N/A (Not an AI model; no training set in this context.)
9. How the ground truth for the training set was established
- N/A (Not an AI model; no training set in this context.)
Summary based on the provided document:
The provided document is an FDA 510(k) clearance letter for Oxalate Urine Controls (Normal & Elevated) and Oxalate Standard. The primary "acceptance criteria" discussed in this letter is substantial equivalence to an existing legally marketed predicate device. The "study that proves the device meets the acceptance criteria" is the premarket notification (510(k)) submission, which contained data (e.g., analytical performance studies) demonstrating that the device is as safe and effective as the predicate. The letter confirms that the FDA reviewed these submissions and determined substantial equivalence. Detailed analytical performance data (accuracy, precision, stability, etc.) would have been part of the 510(k) submission, but is not detailed within this specific public document.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Thermo Electron Corporation c/o Ms. Melita Lambiris Quality Assurance Manager 189-199 Browns Road Noble Park, Victoria, 3174 Australia
MAR 1 6 2007
Re: K062521
Trade/Device Name: Oxalate Urine Controls (Normal & Elevated) Oxalate Standard Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT, JJW Dated: March 01, 2007 Received: March 05, 2007
Dear Ms. Lambiris:
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 (240) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Jean M. Cooper, M.S., D.V.M.
Jean M. Cooper, M.S., 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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INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name:
Oxalate Urine Controls (Normal and Elevated) Oxalate Standard
Indications For Use:
The Oxalate Normal and Elevated Controls are for use in the quality control of the Thermo Oxalate method for the quantitative determination of urine oxalate. The control is used for monitoring accuracy and precision on automated clinical chemistry analysers and for manual operations. It is for in vitro diagnostic use only.
The Oxalate Standard is intended for the calibration of Oxalate assays using the Thermo Oxalate Reagent. It is for in vitro diagnostic use only.
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 IF NEEDED)
Carol Benson
Division Sign-Off
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Office of In Vitro Diagnostic Device
Evaluation and Safety
062521
§ 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.