(77 days)
The ENZ I CAL is an in vitro diagnostic product for the calibration of the LDI method on the Dimension® clinical chemistry system.
ENZ I CAL is a liquid, bovine serum albumin based product containing lactate dehydrogenase (chicken heart). The calibrator packaging contains 4 vials, 2 vials of Level 2 and two vials of Level 3, with 1.5 mL per vial. Level 1 calibrator for LDI is not included in the ENZ I CAL carton. Purified Water Diluent (Cat. No. 710615901) or reagent grade water is required for use as Calibrator Level 1 for the LDI method.
This document is a 510(k) summary for a Calibrator Material (specifically, a lactate dehydrogenase calibrator) used in a clinical chemistry system. The information provided in the input is about a calibration device, not a diagnostic AI device that would have acceptance criteria and performance metrics for patient diagnosis.
Therefore, many of the requested categories are not applicable to the provided document. I will address the applicable points and note where information is not present or relevant for a calibrator.
Here's a breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
The provided 510(k) summary for the "Dimension® clinical chemistry system Enzyme I Calibrator" does not include a table of acceptance criteria and reported device performance in the manner typically expected for a diagnostic device that classifies or predicts. This document focuses on demonstrating substantial equivalence to a predicate device, which is a different regulatory pathway.
The key performance criterion for a calibrator is its traceability and ability to correctly calibrate the assay, which is indirectly addressed by the stated traceability to the IFCC LD method.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a calibrator, not a diagnostic device that uses a test set of patient data. The submission focuses on comparing the new calibrator's characteristics to a predicate calibrator.
3. 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. This is a calibrator. The "ground truth" for a calibrator is its accurately assigned value, which is established through traceability to a reference method (in this case, IFCC LD at 37°C primary reference method). This doesn't involve expert readers for a test set in the same way a diagnostic image analysis algorithm would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no test set or human adjudication process for a calibrator's performance.
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
Not applicable. This is a calibrator, not an AI diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a calibrator, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the calibrator itself, the "ground truth" (or basis for its assigned values) is its traceability to the IFCC LD at 37°C primary reference method. This is a recognized international standard for lactate dehydrogenase measurements.
8. The sample size for the training set
Not applicable. This is a calibrator, not an AI device trained on a dataset.
9. How the ground truth for the training set was established
Not applicable. This is a calibrator, not an AI device.
Summary Table for Applicable Information:
| Category | Description for Dimension® Calibrator (K081789) |
|---|---|
| Acceptance Criteria | Not explicitly stated as "acceptance criteria" for performance in a table for diagnostics. The regulatory acceptance is based on demonstrating substantial equivalence to the predicate device, particularly regarding: - Analyte: Lactate dehydrogenase - Use: Calibration of LDI method - Matrix: Liquid bovine serum albumin base - Form: Liquid - Traceability: IFCC LD at 37°C primary reference method. |
| Reported Device Performance | No specific performance metrics (e.g., sensitivity, specificity, accuracy) are reported for the calibrator itself, as its performance is tied to its ability to accurately calibrate the assay. The report states it is "substantially equivalent" to the predicate. |
| Sample Size (Test Set) | Not applicable (no diagnostic test set). |
| Data Provenance (Test Set) | Not applicable. |
| Number of Experts (Ground Truth) | Not applicable for establishing "ground truth" in the context of diagnostic interpretation. The calibrator's value traceability is established by laboratory practices and international standards. |
| Qualifications of Experts | Not applicable. |
| Adjudication Method | Not applicable. |
| MRMC Comparative Effectiveness Study | Not applicable. |
| Standalone Performance Study (Algorithm Only) | Not applicable. |
| Type of Ground Truth Used | Traceability to IFCC LD at 37°C primary reference method for the calibrator's assigned values. |
| Sample Size (Training Set) | Not applicable (no training set). |
| Ground Truth Establishment (Training Set) | Not applicable. |
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510 (k) Summary for the Dimension® clinical chemistry system Enzyme I Calibrator (DC35)
| 510 (k) Number: | K081789 |
|---|---|
| Analyte: | Lactate dehydrogenase |
| Type of Test: | Calibrator Material |
| Applicant: | Siemens Healthcare Diagnostics IncP.O. Box 6101Newark, DE 19714-6101Helen M. LeeRegulatory Affairs and Compliance ManagerOffice Phone: 302.631.8706Fax: 302.631.6299 |
Proprietary and Established Name:
Dimension® clinical chemistry system Enzyme | Calibrator
Regulatory Information:
Regulation Section: 21 CFR § 862.1150 - Calibrator Classification: Class II
Product Code: JIT - Calibrator, Secondary
Panel: Clinical Chemistry
Intended Use:
The ENZ I CAL is an in vitro diagnostic product for the calibration of the LDI method on the Dimension® clinical chemistry system.
Device Description:
ENZ I CAL is a liquid, bovine serum albumin based product containing lactate dehydrogenase (chicken heart). The calibrator packaging contains 4 vials, 2 vials of Level 2 and two vials of Level 3, with 1.5 mL per vial. Level 1 calibrator for LDI is not included in the ENZ I CAL carton. Purified Water Diluent (Cat. No. 710615901) or reagent grade water is required for use as Calibrator Level 1 for the LDI method.
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Substantial Equivalence Information:
Comparison of the Dimension® clinical chemistry system Enzyme ! Calibrator, proposed device, to the predicate Roche Calibrator for automated systems.
| Item | New Device | Predicate Device |
|---|---|---|
| Analyte | Lactate dehydrogenase. | Multi-analyte; including lactatedehydrogenase. |
| Use | For the calibration of the lactatedehydrogenase (LDI) method on theDimension® clinical chemistry system.For in vitro diagnostic use. | For use in the calibrationof quantitative Roche methods on Rocheclinical chemistry analyzersas specified in the value sheet.For in vitro diagnostic use. |
| Matrix | Liquid bovine serum albumin base withlactate dehydrogenase of chicken liverorigin. | Human serum base with lactatedehydrogenase of porcine heart origin. |
| Form | Liquid | Lyophilized |
| Traceability | IFCC LD at 37 ° C primary referencemethod. | Standardized against the originalformulation and procedures recommendedby the IFCC. |
Comments on Substantial Equivalence:
Both the proposed ® clinical chemistry system Enzyme I Calibrator and the predicate Roche Calibrator for automated systems are traceable to IFCC reference method and used to calibrate IFCC traceable lactate dehydrogenase methods.
Conclusion:
The Dimension® Enzyme | Calibrator is substantially equivalent to the Roche Calibrator for automated systems based upon the information above.
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Image /page/2/Picture/1 description: The image contains the seal of the Department of Health & Human Services, USA. The seal features an eagle-like emblem with three stylized, curved lines representing the eagle's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Siemens Healthcare Diagnostics Inc. c/o Ms. Helen M. Lee 500 GBC Drive P.O. Box 6101, Mailbox 514 Newark, DE 19714-6101
SEP 1 0 2008
K081789 Rc:
Trade/Device Name: Dimension® Chemistry System Enzyme I Calibrator (ENZ I Cal) Regulation Number: 21 CFR§ 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: June 24, 2008 Received: June 25, 2008
Dear Ms. Lee:
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 yours,
Jean M. Cooper, M.S., D.V.M.
Yéan 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
Kori759 510(k) Number (if known):
Device Name:
Dimension® clinical chemistry system Enzyme I Calibrator (ENZ I CAL)
Indications for Use:
The ENZ I CAL is an in vitro diagnostic product for the calibration of LDI method on the Dimension® clinical chemistry system.
Prescription Use (Per 21 CFR 801 Subpart D) Over-The-Counter-Use (21 CFR 801)
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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C Benson
Division Sign-Off
vision Sign-Off
Office of In Vitro Diagnostic De lation and Safe
§ 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.