(121 days)
The Elecsys TSH 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 TSH reagent on the indicated Elecsys cobas e immunoassay analyzers.
The Elecsys TSH CalCheck 5 is a lyophilized product consisting of TSH in equine serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
The provided 510(k) summary for the device, "Elecsys TSH CalCheck 5," is for an in-vitro diagnostic control material. As such, it does not involve clinical studies with human patients, image analysis, or expert-based ground truth establishment in the same way a diagnostic imaging device would. Instead, its "performance" is assessed based on its chemical and physical characteristics and how accurately it can verify instrument calibration and assay ranges.
Therefore, many of the requested categories in the prompt are not applicable to this type of device submission.
Here is an analysis based on the information provided in the K093836 document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" in a quantitative, pass/fail table as would be expected for a diagnostic device. Instead, it states that the device was evaluated for "value assignment and stability." The implication is that the performance characteristics (e.g., how well the assigned values match expectations, and the stability over time) were deemed acceptable for substantial equivalence to the predicate device.
| Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Value Assignment | Assumed to be accurate and consistent with intended use as an assayed control for calibration verification. | Evaluated for value assignment. (Specific data not provided in summary). |
| Stability (Unopened) | Stable at 2-8°C until expiration date. | Same as predicate. |
| Stability (Reconstituted) | Stable at 20-25°C for 4 hours. | Same as predicate. |
| Format | Lyophilized | Same as predicate. |
| Matrix | Equine serum matrix | Same as predicate. |
| Levels of Control | Five distinct levels for calibration verification. | Five levels, an increase from the predicate's three. |
2. Sample Size Used for the Test Set and Data Provenance
- Test set: Not applicable in the traditional sense of patient data. The "test set" would be samples of the manufactured control material itself, used for evaluation. The document does not specify the number of batches or individual vials tested.
- Data Provenance: The exact location or nature of the testing is not specified, but it would have been conducted by Roche Diagnostics as part of their product development and validation process. This would be considered prospective manufacturing and testing data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. For an in-vitro diagnostic control, the "ground truth" is established through highly controlled analytical methods and established reference materials/methods, not through expert human interpretation. The concentrations of TSH in the control material are assigned through a rigorous internal process, not "established by experts."
4. Adjudication Method for the Test Set
- Not Applicable. No human adjudication is involved for this type of chemical control material. The "adjudication" is metrological, relating to the accuracy and precision of the analytical measurements used to assign values and assess stability.
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 of medical images or data. This device is a quality control material for an automated immunoassay analyzer.
6. If a Standalone (Algorithm only without human-in-the-loop performance) was done
- Not Applicable / Inherent. This device itself is not an algorithm or a diagnostic tool; it's a calibrator/control. Its performance is entirely "standalone" in the sense that it is a physical product with defined chemical characteristics. Its interaction is with the immunoassay analyzer, not a human interpreter directly.
7. The Type of Ground Truth Used
- Assigned Values based on Analytical Methods and Reference Materials: The "ground truth" for the Elecsys TSH CalCheck 5 is the assigned TSH concentration values for each of its five levels. These values are determined by the manufacturer (Roche Diagnostics) using highly precise and accurate analytical methods, typically traceable to international reference standards and/or internal established reference methods. This ensures that the control material has known concentrations to verify the performance of the Elecsys TSH reagent and analyzer.
8. The Sample Size for the Training Set
- Not Applicable. This device is a chemical control product, not a machine learning algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. See point 8.
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APR 1 6 _ J10
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. Submitter Roche Diagnostics name, address, 9115 Hague Road, P.O. Box 50416 contact Indianapolis, IN 46250-0416 317-521-3577 Contact Person: Kelly Colleen O'Maine Adams Phone: 317-521-3577 Fax: 317-521-2324 Email: colleen.adams@roche.com Secondary Contact: Stephanie Greeman Phone: 317-521-2458 Fax: 317-521-2324 Email: stephanie.greeman@roche.com Date Prepared: March 17, 2010 Device Name Proprietary name: Elecsys TSH CalCheck 5 Common name: TSH CalCheck 5 Classification name: Single (specified) analyte controls (assayed and unassayed) Predicate The Elecsys TSH CalCheck 5 is substantially equivalent to other products in device commercial distribution intended for similar use. We claim equivalency to the currently marketed Elecsys CalCheck TSH (K963147). Device The Elecsys TSH CalCheck 5 is a lyophilized product consisting of Description TSH in equine serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels. Intended use The Elecsys TSH 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 TSH reagent on the indicated Elecsys cobas e immunoassay analyzers.
Continued on next page
Page 1 of 2
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510(k) Summary, Continued
| ComparisonTable | The table below compares Elecsys TSH CalCheck 5 with the predicatedevice, Elecsys CalCheck TSH (K963147). | |
|---|---|---|
| Characteristic | Elecsys CalCheck TSH(K963147) | Elecsys TSH CalCheck 5 |
| Intended Use | For use in the verification of thecalibration established by theElecsys TSH reagent on theindicated Elecsys and cobas eimmunoassay analyzers. | The Elecsys TSH CalCheck 5 is anassayed control for use incalibration verification and for usein the verification of the assay rangeestablished by the Elecsys TSHreagent on the indicated Elecsyscobas e immunoassay analyzers. |
| Levels | Three | Five |
| Format | Lyophilized | Same |
| Handling | Reconstitute the contents of Check1, Check 2 and Check 3 withexactly 1.0 mL distilled ordeionized water. Allow the bottle tostand closed for 15 minutes. Mixgently by inversion to ensurehomogeneity. | 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 | Equine serum matrix | Same |
Performance
Characteristics
The Elecsys TSH CalCheck 5 was evaluated for value assignment and stability.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, in blue. The caduceus is surrounded by a circular inscription that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The logo is simple and clean, with a focus on the department's name and the national affiliation.
Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
APR 3 0 2010
Roche Diagnostics Roche Professional Diagnostics c/o Ms. Kelly Colleen O'Maine Adams Regulatory Affairs Consultant 9115 Hague Road, PO Box 50416 Indianapolis, IN 46250-0416
Re: K093836 Trade Name: Elecsys TSH 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: February 08, 2010 Received: February 12, 2010
Dear Ms. O'Maine Adams:
This letter corrects our substantially equivalent letter of April 15, 2010.
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 (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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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/Resourcesfor You/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 TSH CalCheck 5
Indication For Use:
The Elecsys TSH 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 TSH reagent an 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) K093836
Page I of I
§ 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.