(30 days)
The Elecsys Troponin I CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys Troponin I reagent on the indicated Elecsys and cobas e immunoassay analyzers.
The Elecsys Troponin I CalCheck 5 is a lyophilized product consisting of recombinant human cardiac Troponin I in human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
This document describes the Elecsys Troponin I CalCheck 5, a lyophilized product containing recombinant human cardiac Troponin I in a human serum matrix. It is intended for use in calibration verification and to verify the assay range established by the Elecsys Troponin I reagent on Elecsys and cobas e immunoassay analyzers.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Intended Use | "an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys Troponin I reagent" | Substantially equivalent to predicate device with the same intended use for Troponin I. |
| Levels | Five | Five |
| Format | Lyophilized | Lyophilized |
| Matrix | Human serum matrix | Human serum matrix |
| Handling Instructions | "Reconstitute the contents of each vial with exactly 1.0 mL distilled or deionized water; Allow the bottle to stand closed for 15 minutes. Mix gently by inversion to ensure homogeneity." | Same as predicate device. |
| Stability (Unopened) | Store at 2-8°C until expiration date | Same as predicate device. |
| Stability (Reconstituted) | 20 – 25°C : 4 hrs | Same as predicate device. |
| Value Assignment | Not explicitly stated, implied to be comparable to predicate. | Evaluated. Data indicate substantial equivalence. |
| Stability (general) | Not explicitly stated, implied to be comparable to predicate. | Evaluated. Data indicate substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set in the conventional sense of a clinical study. The evaluation focused on "value assignment and stability" of the control material itself. Therefore, the "sample size" would refer to the number of vials/batches tested for these characteristics. This information is not provided in the summary.
Data Provenance: Not specified, but generally, studies for IVD control materials are conducted internally by the manufacturer, typically in a controlled laboratory setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a characteristic for a diagnostic device that interprets or classifies. For an assayed control material, "ground truth" relates to the assigned value and stability of the control and is established through rigorous internal testing and calibration processes, not expert consensus on individual cases.
4. Adjudication Method for the Test Set
Not applicable for a control material. Ground truth is established through laboratory measurement and metrological traceability, not expert adjudication of individual results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. An MRMC study is relevant for diagnostic devices that involve human interpretation (e.g., imaging devices) to assess reader performance with and without AI assistance. This document describes an assayed control material, which does not involve human readers interpreting results in the same way.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
This concept is not directly applicable. The device is a "control" material, not an "algorithm." Its performance is inherent in its chemical and physical properties (concentration, stability). The "study" for this device evaluated its intrinsic characteristics (value assignment and stability) against its predicate, not its performance as a standalone diagnostic algorithm.
7. The Type of Ground Truth Used
For a control material like Elecsys Troponin I CalCheck 5, the "ground truth" would be:
- Assigned Values: The target concentrations of Troponin I in each of the five levels, established through a rigorous value assignment process, usually involving reference methods or highly characterized internal standards.
- Stability Specifications: The predefined parameters for how long the control material maintains its assigned values under specified storage and handling conditions.
The document states, "The Elecsys Troponin I CalCheck 5 was evaluated for value assignment and stability." This indicates these intrinsic properties formed the basis of the performance evaluation.
8. The Sample Size for the Training Set
Not applicable. This device is a control material, not a machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As this is not a machine learning device, there is no training set or associated ground truth in that context.
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Roche Diagnostics
KL00594
d t,
Elecsys Troponin I CalCheck 5
510(k) Summary
APR - 1 2010
| 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 Diagnostics9115 Hague RoadIndianapolis, IN 46250 |
| Contact Person: Sarah BaumannPhone: 317-521-3952Fax: 317-521-2324Email: sarah.baumann@roche.com | |
| Secondary Contact: Stephanie GreemanPhone: 317-521-2458Fax: 317-521-2324Email: stephanie.greeman@roche.com | |
| Date Prepared: March 1, 2010 | |
| Device Name | |
| Predicatedevice | The Elecsys Troponin I CalCheck 5 is substantially equivalent to otherproducts in commercial distribution intended for similar use. We claimequivalency to the currently marketed Elecsys HCG+β CalCheck 5(K092168). |
| DeviceDescription | The Elecsys Troponin I CalCheck 5 is a lyophilized product consisting ofrecombinant human cardiac Troponin I in human serum matrix. Duringmanufacture, the analyte is spiked into the matrix at the desired concentrationlevels. |
| Intended use | The Elecsys Troponin I CalCheck 5 is an assayed control for use incalibration verification and for use in the verification of the assay rangeestablished by the Elecsys Troponin I reagent on the indicated Elecsys andcobas e immunoassay analyzers. |
| Continued on next page |
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510(k) Summary, Continued
The table below compares Elecsys Troponin I CalCheck 5 with the predicate Comparison Table device, Elecsys HCG+β Calcheck 5 (K092168).
| Characteristic | Elecsys HCG+β CalCheck 5(K092168) | Elecsys Troponin I CalCheck 5 |
|---|---|---|
| Intended Use | The Elecsys HCG+β CalCheck 5 isan assayed control for use incalibration verification and for use inthe verification of the assay rangeestablished by the Elecsys HCG+βreagent on the indicated Elecsys andcobas e immunoassay analyzers. | The Elecsys Troponin I CalCheck 5 isan assayed control for use incalibration verification and for use inthe verification of the assay rangeestablished by the Elecsys Troponin Ireagent on the indicated Elecsys andcobas e immunoassay analyzers. |
| Levels | Five | Same |
| Format | Lyophilized | Same |
| Matrix | Human serum matrix | Same |
| Handlinginstructions | Reconstitute the contents ofeach vial with exactly 1.0 mL distilledor deionized water.Allow the bottle to stand closed for 15minutes. Mix gently by inversion toensure homogeneity. | Same |
| Stability | Unopened:• Store at 2-8°C until expiration dateReconstituted:• 20 – 25°C : 4 hrs | Same |
| Performance | Characteristics | The Elecsys Troponin I CalCheck 5 was evaluated for value assignment and stability. |
|---|---|---|
| Conclusion | The data demonstrate that the performance of the Elecsys Troponin ICalCheck 5 is substantially equivalent to that of the predicate device,Elecsys HCG+β CalCheck 5 (K092168). |
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Image /page/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines and a wavy base.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Roche Diagnostics c/o Sarah Baumann Regulatory Affairs Consultant Roche Professional Diagnostics 9115 Hague Road, P.O. Box 50410 Indianapolis, IN 46250-0416, USA
APR 0 1 2010
Re: K100594 Elecsys Troponin I CalCheck 5 Trade/Device Name: Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: Class I, reserved Product Code: JJX Dated: March 1, 2010 Received: March 2, 2010
Dear Ms. Baumann
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).
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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
signature
Courtney C. Harper, Ph.D. 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
510(k) Number (if known):
Device Name: Elecsys Troponin I CalCheck 5
Indication For Use:
The Elecsys Troponin I CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys Troponin I reagent on the indicated Elecsys and cobas e immunoassay analyzers.
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
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K100594
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.