(118 days)
The Elecsys HCG+B 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 HCG+B reagent on the indicated Elecsys and cobas e immunoassay analyzers.
The Elecsys HCG+$\beta$ CalCheck 5 is a lyophilized product consisting of HCG in human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
This document describes the Elecsys HCG+β CalCheck 5, an assayed control for use in calibration verification and verification of the reportable range of Elecsys HCG+β reagent on Elecsys and cobas e immunoassay analyzers.
It's important to note that this document is a 510(k) summary, which focuses on demonstrating "substantial equivalence" to a predicate device for market clearance. It does not contain detailed information about acceptance criteria or a comprehensive study report with the level of detail requested for AI/ML device evaluations. The device described here is a control material for laboratory assays, not an AI/ML diagnostic device. Therefore, many of the requested fields, such as "number of experts used to establish ground truth," "adjudication method," "MRMC study," "stand-alone study," "type of ground truth," and "sample size for training/test sets" as understood in the context of AI/ML, are not applicable to this type of medical device.
The provided text focuses on comparing the new device (Elecsys HCG+β CalCheck 5) to a predicate device (Elecsys HCG+β CalCheck) to establish substantial equivalence.
Here's an attempt to answer the questions based on the available information, noting where information is not present or not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed performance data in a results table format as would be expected for an AI/ML device. Instead, performance is generally described within the context of substantial equivalence to the predicate.
| Characteristic | Acceptance Criteria (Implicit from Predicate Comparison) | Reported Device Performance |
|---|---|---|
| Intended Use | Equivalent to predicate for calibration verification; extended to include verification of reportable range and additional analyzers. | Met: Intended use includes calibration verification and verification of reportable range on indicated Elecsys and cobas e immunoassay analyzers. |
| Levels | Not explicitly stated beyond "Three" for predicate. | Met: Increased levels from 3 (predicate) to 5. |
| Format | Identical to predicate (Lyophilized). | Met: Lyophilized. |
| Handling | Similar reconstitution process, specific volumes for each check. | Met: Similar reconstitution process, specific 1.0 mL for all 5 checks. |
| Stability | Equivalent to predicate (Unopened: Store at 2-8°C until expiration date; Reconstituted: 20 – 25°C : 4 hrs). | Met: Same stability as predicate. |
| Matrix | Identical to predicate (Human serum matrix). | Met: Human serum matrix. |
| Value Assignment | (Implicitly, values should be appropriately assigned and traceable) | Evaluated: "The Elecsys HCG+β CalCheck 5 was evaluated for value assignment..." (No specific data provided in this summary). |
| Stability | (Implicitly, stability should be maintained for the stated periods) | Evaluated: "...and stability." (No specific data provided in this summary). |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: This information is not provided in the 510(k) summary. For a control material, "test set" would typically refer to the number of batches produced and tested, or the number of runs performed during validation.
- Data Provenance: This information is not provided. The studies would have been conducted by Roche Diagnostics, likely in their labs. The document does not specify if data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable as this is a medical device (calibration control), not an AI/ML diagnostic system requiring expert interpretation of complex inputs to establish ground truth. The "ground truth" for a control material would be its manufacturing specifications and assigned values, verified through analytical methods.
4. Adjudication method for the test set
- This question is not applicable as there is no interpretative "test set" requiring adjudication by multiple readers for this type of device.
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
- This question is not applicable. This is a control material, not an AI/ML diagnostic device that interacts with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. This is a control material, not an algorithm.
7. The type of ground truth used
- The "ground truth" for a calibrator/control material like Elecsys HCG+β CalCheck 5 would be assigned values based on a traceable reference method and/or reference materials, established during the manufacturing and characterization process. It is about the physicochemical properties and concentration of HCG in the control, not an interpretative diagnosis.
8. The sample size for the training set
- This question is not applicable. This is a control material, not an AI/ML device that requires a "training set."
9. How the ground truth for the training set was established
- This question is not applicable.
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510(k) Summary
| 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 46250317-521-3952NOV 1 6 2009Contact Person: Sarah BaumannPhone: 317-521-3952Fax: 317-521-2324Email: sarah.baumann@roche.comSecondary Contact: Stephanie GreemanPhone: 317-521-2458Fax: 317-521-2324Email: stephanie.greeman@roche.comDate Prepared: July 16, 2009 |
| Device Name | Proprietary name: Elecsys HCG+$\beta$ CalCheck 5Common name: HCG+$\beta$ CalCheck 5Classification name: Single (specified) analyte controls (assayed andunassayed) |
| Predicatedevice | The Elecsys HCG+$\beta$ CalCheck 5 is substantially equivalent to other productsin commercial distribution intended for similar use. We claim equivalency tothe currently marketed Elecsys HCG+$\beta$ CalCheck (K010237). |
| DeviceDescription | The Elecsys HCG+$\beta$ CalCheck 5 is a lyophilized product consisting ofHCG in human serum matrix. During manufacture, the analyte is spiked intothe matrix at the desired concentration levels. |
| Intended use | The Elecsys HCG+ $\beta$ CalCheck 5 is an assayed control for use in calibrationverification and for use in the verification of the reportable range establishedby the Elecsys HCG+$\beta$ reagent on the indicated Elecsys and cobas eimmunoassay analyzers. |
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15092168
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510(k) Summary, Continued
1
The table below compares Elecsys HCG+B CalCheck 5 with the predicate Comparison Table device, Elecsys HCG+β Calcheck (K010237).
| Characteristic | Elecsys HCG+β CalCheck(K010237) | Elecsys HCG+β CalCheck 5 |
|---|---|---|
| Intended Use | For use in the verification of thecalibration established by theElecsys HCG+β reagent on Elecsys1010 or 2010 immunoassayanalyzers. | The Elecsys HCG+ β CalCheck 5 isan assayed control for use incalibration verification and for usein the verification of the reportablerange established by the ElecsysHCG+β reagent on the indicatedElecsys and cobas e immunoassayanalyzers. |
| Levels | Three | Five |
| Format | Lyophilized | Same |
| Handling | Reconstitute Check 1 and Check 2with exactly 1.0 mL distilled ordeionized water. ReconstituteCheck 3 with exactly 1.5 mLdistilled or deionized water. Allowto stand closed for 15 minutes, thenmix gently by inversion. | Reconstitute Check 1, Check 2,Check 3, Check 4, and Check 5with exactly 1.0 mL distilled ordeionized water. Allow to standclosed for 15 minutes, then mixgently by inversion. |
| Stability | Unopened:Store at 2-8°C until expirationdateReconstituted:20 – 25°C : 4 hrs | Same |
| Matrix | Human serum matrix | Same |
Performance Characteristics The Elecsys HCG+B CalCheck 5 was evaluated for value assignment and stability.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three lines forming its body and wings, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Roche Diagnostics c/o Ms. Sarah Baumann 9115 Hague Road, P.O. Box 50410 Indianapolis, IN 46250-0416
NOV 1 6 2009
Re: K092168
Trade/Device Name: Elecsys hCG+B 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: October 20, 2009 Received: October 21, 2009
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 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 (reporting of
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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
1092168 510(k) Number (if known):
Device Name: Elecsys HCG+B CalCheck 5
Indication For Use:
The Elecsys HCG+B 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 HCG+B 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 Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K092168
§ 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.