(53 days)
The Elecsys Insulin 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 Insulin reagent on the indicated Elecsys and cobas e immunoassay analyzers.
The Elecsys Insulin CalCheck 5 is a lyophilized product consisting of recombinant human insulin in bovine serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
The provided text is a 510(k) summary for the Elecsys® Insulin CalCheck 5. This document focuses on demonstrating substantial equivalence to a predicate device for regulatory approval for a quality control material, not a diagnostic device with performance metrics like sensitivity, specificity, or accuracy for diagnosing a condition.
Therefore, the information typically requested in your prompt (e.g., acceptance criteria for diagnostic performance, sample size for test sets with ground truth, MRMC studies, standalone algorithm performance) is not applicable to this type of device and submission.
Here's a breakdown of why and what information is provided:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in terms of diagnostic performance. For a quality control material, acceptance criteria would typically relate to its manufacturing consistency, stability, and its ability to challenge the assay within expected ranges.
- Reported Device Performance: The primary "performance" studied and reported here is related to value assignment and stability. The document states: "The Elecsys Insulin CalCheck 5 was evaluated for value assignment and Performance Characteristics stability." However, specific numerical results or acceptance ranges for these evaluations are not detailed in the provided 510(k) summary. The conclusion simply states that the data demonstrates "substantially equivalent" performance to the predicate.
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. As a quality control material, there isn't a "test set" of patient data for diagnostic evaluation. The evaluations would involve laboratory experiments to assess the material itself. The document does not specify the number of lots or experimental runs used for value assignment or stability studies.
- Data Provenance: Not specified, but the manufacturer is Roche Diagnostics (Indianapolis, IN, USA).
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. Ground truth, in the context of diagnostic performance, is not relevant for a quality control material.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No test set for diagnostic performance is involved.
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 quality control material, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable.
8. The sample size for the training set:
- Not Applicable. This is not an algorithm or AI device that requires "training data."
9. How the ground truth for the training set was established:
- Not Applicable.
In summary, for K101075 (Elecsys® Insulin CalCheck 5):
The submission is for a quality control material used for calibration verification and assay range verification. The study focused on demonstrating "substantial equivalence" of its "value assignment and Performance Characteristics stability" to a previously cleared predicate device (Elecsys HCG+β CalCheck 5). The detailed technical data from these evaluations (e.g., specific stability curves, results of value assignment studies) is not included in the provided 510(k) summary, only the general conclusion of equivalence.
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Roche Diagnostics
Elecsys® Insulin CalCheck 5
| 510(k) Summary | |||
|---|---|---|---|
| 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. | ||
| Submittername, address,contact | Roche Diagnostics9115 Hague RoadIndianapolis, IN 46250JUN 11 2010 | ||
| 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: April 16, 2010 | |||
| Device Name | Proprietary name: Elecsys® Insulin CalCheck 5Common name: Insulin CalCheck 5Classification name: Single (specified) analyte controls (assayed andunassayed) | ||
| Predicatedevice | The Elecsys Insulin CalCheck 5 is substantially equivalent to other productsin commercial distribution intended for similar use. We claim equivalency tothe currently marketed Elecsys HCG+B CalCheck 5 (K092168). | ||
| DeviceDescription | The Elecsys Insulin CalCheck 5 is a lyophilized product consisting ofrecombinant human insulin in bovine serum matrix. During manufacture, theanalyte is spiked into the matrix at the desired concentration levels. | ||
| Intended use | The Elecsys Insulin CalCheck 5 is an assayed control for use in calibrationverification and for use in the verification of the assay range established bythe Elecsys Insulin reagent on the indicated Elecsys and cobas eimmunoassay analyzers. | ||
Continued on next page
Confidential
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Roche Diagnostics
510(k) Summary, Continued
| Comparison | The table below compares Elecsys Insulin CalCheck 5 with the predicate |
|---|---|
| Table | device, Elecsys HCG+B Calcheck 5 (K092168). |
| Characteristic | Elecsys HCG+β CalCheck 5(K092168) | Elecsys Insulin 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 Insulin CalCheck 5 isan assayed control for use incalibration verification and for use inthe verification of the assay rangeestablished by the Elecsys Insulinreagent on the indicated Elecsys andcobas e immunoassay analyzers. |
| Matrix | Human serum matrix | Bovine serum matrix |
| Levels | Five | Same |
| Format | Lyophilized | 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 |
The Elecsys Insulin CalCheck 5 was evaluated for value assignment and Performance Characteristics stability. Conclusion The data demonstrate that the performance of the Elecsys Insulin CalCheck 5 is substantially equivalent to that of the predicate device, Elecsys HCG+β CalCheck 5 (K092168).
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DEPARTMENT OF HEALTH & HUMAN SERVICES.USA
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
Roche Diagnostics Corp. c/o Ms. Sarah Baumann Regulatory Affairs Consultant 9115 Hague Road, PO Box 50410 Indianapolis, IN 46250-0416
JUN 1 1 2010
K101075 Re: Trade Name: Elecsys® Insulin CalCheck 5 Regulation Number: 21 CFR §862.1660 Regulation Name: Quality control material (assayed and unassayed). Regulatory Class: Class I, reserved Product Codes: JJX Dated: April 16, 2010 Received: April 19, 2010
Dear Ms. Baumann:
We have reviewed your Section 510(k) premarket notification of intent to market the we have formed your ood have determined the device is substantially equivalent (for de recolorenene 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 marketed in meetstate ovents, 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 with the provisions of thapproval application (PMA). You may, therefore, market the approvide of a promazions provisions of the Act. The general controls actives, subject to Act include requirements for annual registration, listing of devices, provisions of the ing 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 (1 Wrift), It may of basice 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 I fouse oo aa ADDA has made a determination that your device complies with other not firements 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 I coderal agencies: "Fou mast compy 1 CFR Part 807); labeling (21 CFR Parts 801 and 1111164 to: reporting (reporting (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).
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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,
CA
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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Indications for Use Form
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Elecsys Insulin CalCheck 5
Indications for Use: The Elecsys Insulin 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 Insulin reagent on the indicated Elecsys and cobas e immunoassay analyzers.
Over-The-Counter Use Prescription Use Prescription Use _____________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) .
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C. Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K101075
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§ 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.