(20 days)
The LOCI® TNI CAL is an in vitro diagnostic product for the calibration of the Cardiac Troponin I (TNI) method on the Dimension® EXL™ integrated chemistry system with LOCI® module.
The LOCI® Cardiac Troponin I Calibrator is a liquid, frozen, human serum based product containing native human troponin complex with other components designed to stabilize the product.
The provided text describes the 510(k) summary for the LOCI® Cardiac Troponin I Calibrator, focusing on its substantial equivalence to a predicate device. This document is a regulatory submission for a calibrator, which is a reference material used to standardize a diagnostic test. Therefore, the "device" in this context is the calibrator itself, not an AI-powered diagnostic system.
As such, many of the requested elements for describing AI device performance (like multi-reader multi-case studies, AI assistance effect size, standalone algorithm performance, number of experts for ground truth, or sample size for AI training sets) are not applicable to this type of device and are not found in the provided text.
However, I can extract the relevant information available for this calibrator:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state quantitative acceptance criteria or detailed performance data in a table format for the LOCI® Cardiac Troponin I Calibrator. Instead, it focuses on the "stability" as a key performance characteristic established through real-time data. The primary "performance" reported is that it has been determined to be "substantially equivalent" to the predicate device.
| Feature | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Stability | Established through real-time data on 3 lots of product; must pass pre-defined acceptance criteria. | "The stability of the calibrators is established through real-time data on 3 lots of product. Testing is conducted at multiple time points and must pass pre-defined acceptance criteria." (Specific data not provided) |
| Technological Characteristics | Substantial equivalence to predicate device (Dimension Vista® Cardiac Troponin I Calibrator) | "Based on a review of the devices technological features, the LOCI® Cardiac Troponin I Calibrator is substantially equivalent to the legally marketed device, the Dimension Vista® Cardiac Troponin I Calibrator." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: For stability testing, "3 lots of product" were used. The document does not specify the number of individual calibrator vials or measurements within each lot.
- Data Provenance: The data is generated internally by Siemens Healthcare Diagnostics Inc. and is described as "real-time data." It is prospective in the sense that stability studies are conducted over time as the product ages. The country of origin of the data is not explicitly stated but would be consistent with the submitter's location (Newark, DE, USA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a calibrator, not a diagnostic device requiring expert interpretation of results for ground truth establishment. The "ground truth" for a calibrator would refer to the true assigned values of the troponin I concentrations, which are determined through a manufacturing and standardization process, traceable to an internal master pool.
4. Adjudication Method for the Test Set
Not applicable. This is a calibrator, and its performance (e.g., stability, effectiveness in calibration) is assessed through analytical testing against predefined specifications, not through expert adjudication of diagnostic outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. MRMC studies are for diagnostic devices involving human interpretation, often with AI assistance, and are not relevant for a calibrator.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
No. This concept is not applicable to a calibrator. The "performance" of the calibrator is its ability to accurately and consistently calibrate the associated assay, which is evaluated through laboratory methods.
7. The Type of Ground Truth Used
The ground truth for the calibrator's nominal values is established by traceability to an "internal master pool containing human cardiac troponin complex." This means the assigned values are based on a reference standard maintained by the manufacturer.
8. The Sample Size for the Training Set
Not applicable. Calibrators are not "trained" in the machine learning sense. Their nominal values and performance characteristics are determined through manufacturing processes and analytical validation.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8. The "ground truth" for its assigned values ("nominal values") is established through traceability to an internal master pool.
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510(k) Summary of Safety and Effectiveness LOCI® Cardiac Troponin I Calibrator
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigncd 510(k) number is:
081683
1. Submitter's Contact Information and Date of Preparation
Mrs. Yuk-Ting Lewis Submitter's Contact Information: Siemens Healthcare Diagnostics Inc. P.O. Box 6101 Newark, DE 19714 Tel: 302-631-7626
Date of Preparation:
June 12, 2008
Proprietary Device Name / FDA Classification Name 2.
LOCI® Cardiac Troponin I Calibrator / 21 CFR 862.1150
3. Identification of the Predicate Device
Dimension Vista® Cardiac Troponin I Calibrator, K053577
Device Description 4.
The LOCI® Cardiac Troponin I Calibrator is a liquid, frozen, human serum based product containing native human troponin complex with other components designed to stabilize the product. The calibrator levels and their nominal values are:
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క. Device Intended Use
The LOCI® TNI CAL is an in vitro diagnostic product for the calibration of the Cardiac Troponin I (TNI) method on the Dimension® EXL™ integrated chemistry system with LOCI® module.
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6. Summary of the devices technological characteristics
A comparison of the LOCI® Cardiac Troponin I Calibrator vs. the predicate device is provided.
| Feature | Predicate Device:Dimension Vista® CardiacTroponin I Calibrator | New Device:LOCI® Cardiac Troponin ICalibrator |
|---|---|---|
| Intended Use | The CTNI CAL is an in vitrodiagnostic product for thecalibration of Cardiac TroponinI (CTNI) on the DimensionVista system. | The LOCI® TNI CAL is an invitro diagnostic product for thecalibration of the CardiacTroponin I (TNI) method on theDimension® EXL™ integratedchemistry system with LOCI®module. |
| Analyte | Human troponin complex | |
| Matrix | Human serum | |
| Form | The calibrators are in a liquid, frozen form. | |
| Calibrator levels | The CTNI Calibrator kitcontains twelve (12) vials; twoat each level. The nominalvalues are 0, 0.4, 4, 8, 20, and41 ng/mL. | The LOCI® TNI Calibrator kitcontains ten (10) vials; two vialsat each level. The nominalvalues are 0.00, 0.60, 6.00,20.00, and 43.00 ng/mL. |
| Stability | The stability of the calibrators is established through real-time dataon 3 lots of product. Testing is conducted at multiple time pointsand must pass pre-defined acceptance criteria. | |
| Traceability | The calibrator is traceable to an internal master pool containinghuman cardiac troponin complex. |
7. Conclusion
Based on a review of the devices technological features, the LOCI® Cardiac Troponin I Calibrator is substantially equivalent to the legally marketed device, the Dimension Vista® Cardiac Troponin I Calibrator.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three stripes representing the department's mission to promote health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Siemens Healthcare Diagnostics, Inc. c/o Yuk-Ting Lewis RA & Compliance Manager P.O. Box 6101, M/S 514 Newark, DE 19714
JUL - 7 2008
Re: K081683 Trade/Device Name: LOCI® Cardiac Troponin I Calibrator Regulation Number: 21 CFR §862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: June 13, 2008 Received: June 17, 2008
Dear Ms. Lewis:
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.
Yean 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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Indication for Use
K081683 510(k) Number (if known):
Device Name: LOCI® Cardiac Troponin I Calibrator
Indications For Use:
The LOCI® TNI CAL is an in vitro diagnostic product for the calibration of the Cardiac Troponin I (TNI) method on the Dimension® EXL™ integrated chemistry system with LOCI® module.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Carol C. Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K081683
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§ 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.