(51 days)
The Elecsys Myoglobin 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 Myoglobin reagent on the indicated Elecsys and cobas e immunoassay analyzers.
The Elecsys Myoglobin CalCheck 5 is a liquid product consisting of human myoglobin in a buffer/protein (bovine serum) matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
The provided text describes the Elecsys Myoglobin CalCheck 5, a liquid control product used for calibration verification and assay range verification on Elecsys and cobas e immunoassay analyzers. However, the text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The document is a 510(k) summary for the device, focusing on its description, intended use, and comparison to a predicate device (Elecsys Digoxin CalCheck 5). It also includes the FDA's letter granting substantial equivalence.
Therefore, I cannot populate the table or answer most of the questions based on the provided input.
Here's what can be stated based on the given information:
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Table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not provided in the text.
- Reported Device Performance: The "Performance Characteristics" section only states: "The Elecsys Myoglobin CalCheck 5 was evaluated for value assignment and stability." No specific performance data or criteria are given.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- No information provided.
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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 as no test set evaluation is described.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as no test set adjudication is described.
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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 device is a quality control material, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a quality control material, not an algorithm.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. For a quality control material, "ground truth" would typically refer to the accurately assigned values of the analyte within the control. The text mentions "value assignment" but does not detail the method or source of "ground truth" for these values.
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The sample size for the training set
- Not applicable. This device is a quality control material, not a machine learning model.
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How the ground truth for the training set was established
- Not applicable.
Summary of what is known:
The document describes the Elecsys Myoglobin CalCheck 5 as a liquid product containing human myoglobin in a buffer/protein matrix, "spiked into the matrix at the desired concentration levels" during manufacture, for use in calibration verification and assay range verification. It also mentions an evaluation for "value assignment and stability" was performed. However, details of these evaluations, including specific acceptance criteria, performance results, or how the "ground truth" (i.e., the assigned values) was established, are not provided in this excerpt.
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510(k) Summary
SEP 1 4 2011
·
| 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 Diagnostics9115 Hague Road, P.O. Box 50416Indianapolis, IN 46250-0416317-521-3501 |
| Contact Person: Kelly Colleen O'Maine AdamsPhone: 317-521-3577Fax: 317-521-2324Email: colleen.adams@roche.com | |
| Secondary Contact: Stephanie GreemanPhone: 317-521-2458Fax: 317-521-2324Email: stephanie.greeman@roche.com | |
| Date Prepared: July 22, 2011 | |
| Device Name | Proprietary name: Elecsys Myoglobin CalCheck 5Common name: Myoglobin CalCheck 5Classification name: Single (specified) analyte controls (assayed and unassayed) |
| Predicate device | The Elecsys Myoglobin CalCheck 5 is substantially equivalent to other products in commercial distribution intended for similar use. We claim equivalency to the currently marketed Elecsys Digoxin CalCheck 5 (K102044). |
| Device Description | The Elecsys Myoglobin CalCheck 5 is a liquid product consisting of human myoglobin in a buffer/protein (bovine serum) matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels. |
| Intended use | The Elecsys Myoglobin 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 Myoglobin reagent on the indicated Elecsys and cobas e immunoassay analyzers. |
| Continued on next page |
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510(k) Summary, Continued
Comparison Table The table below compares Elecsys Myoglobin CalCheck 5 with the predicate devices, Elecsys Digoxin CalCheck 5 (K102044).
| Characteristic | Elecsys Myoglobin CalCheck 5(Candidate) | Elecsys Digoxin CalCheck 5(K102044) |
|---|---|---|
| Intended Use | The Elecsys Myoglobin Calcheck 5 isan assayed control for use incalibration verification and for use inthe verification of the assay rangeestablished by the Elecsys Myoglobinreagent on the indicated Elecsys andcobas e immunoassay analyzers. | The Elecsys Digoxin Calcheck 5 is anassayed control for use in calibrationverification and for use in theverification of the assay rangeestablished by the Elecsys Digoxinreagent on the indicated Elecsys andcobas e immunoassay analyzers. |
| Analyte | Myoglobin | Digoxin |
| Levels | Five | Same |
| Format | Liquid | Same |
| Handling | Mix gently by inversion to ensurehomogeneity. | Same |
| Stability | Unopened:• Store at 2-8°C until expiration dateOpened:• 20-25°C: 4 hours | Unopened:• SameOpened:• 20-25°C: 6 hours |
| Matrix | Bovine serum matrix | Same |
Performance Characteristics The Elecsys Myoglobin CalCheck 5 was evaluated for value assignment and stability.
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Public Health Service
Roche Diagnostics Ms. Kelly Colleen O'Maine Adams 9115 Hague Road Indianapolis, IN 46250-0416
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
SEP 1 4 2041
Re: K112113
Trade/Device Name: Elecsys Myoglobin CalCheck 5 Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: Class I, reserved Product Code: JJX Dated: 22 July, 2011 Received: 27 July, 2011
Dear Ms. Adams:
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. Ilisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), 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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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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Page 2 -
If you desire specific advice for your device on our labeling regulation (2) CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, prease the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Pari 802 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 responsible of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.hum 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 1011-free number (800) 638-204) 186-5680 or at its laternet address http://www.fda.gov/MedicalDevices/ResourcesSorYou/Industry/df('auti.htm.
Sincerely yours.
j
Courtney H. Lias, 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
KII2113 510(k) Number (if known):
Device Name: Elecsys Myoglobin CalCheck 5
Indication For Use:
The Elecsys Myoglobin 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 Myoglobin 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)
Signature of Offeror
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) k 112113
§ 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.