(70 days)
The Elecsys Prolactin II 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 Prolactin II reagent on the indicated Elecsys and cobas e immunoassay analyzers.
The Elecsys Prolactin II CalCheck 5 is a lyophilized product consisting of prolactin in an equine serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
The provided text describes the Elecsys Prolactin II CalCheck 5, an assayed control for calibration verification and assay range verification. It is a control material, not an AI/ML powered device, therapeutic device, or diagnostic device that directly analyzes patient data for clinical decisions. Therefore, much of the requested information (e.g., sample sizes for test sets, expert ground truth, MRMC studies, standalone performance, training set details) is not applicable or cannot be extracted from the provided text for this type of device.
However, I can extract information related to its "performance" as a control material:
1. Table of acceptance criteria and the reported device performance:
The document mentions "Performance The Elecsys Prolactin II CalCheck 5 was evaluated for value assignment and Characteristics stability." However, it does not explicitly state specific numerical acceptance criteria or detailed reported performance figures for these evaluations. It only states what was evaluated.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Value Assignment | Evaluated |
| Stability | Evaluated |
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. The "device" is a control material, not a diagnostic or AI device that uses a test set of patient samples in the traditional sense. The evaluations would involve testing the control material itself in laboratory settings. The document does not specify sample sizes for these internal evaluations or data provenance regarding origin or retrospective/prospective nature.
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. As a control material, "ground truth" is typically established by certified reference methods or established assays in a laboratory setting, not by human experts interpreting clinical data. The document does not provide details on how the "value assignment" was established.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. This concept is relevant for studies involving human interpretation or subjective assessments, which is not the primary function of a control material's performance evaluation.
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 device is a control material, not an AI-powered diagnostic tool, so MRMC studies involving human readers and AI assistance are not relevant.
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-powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The document does not explicitly state the type of ground truth used for "value assignment." For control materials, this typically refers to the assigned concentration of the analyte (Prolactin II in this case). This assignment is usually performed by manufacturers using highly accurate assays or reference methods, but the specific methodology is not detailed in this summary.
8. The sample size for the training set:
Not applicable. This device 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:
Not applicable. This device is a control material, not an AI/ML device that requires a training set.
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510(k) Summary
ﺎ،
| 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 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: March 2, 2011 | |
| Device Name | Proprietary name: Elecsys Prolactin II CalCheck 5Common name: Prolactin II CalCheck 5Classification name: Single (specified) analyte controls (assayed andunassayed) |
| Predicatedevice | The Elecsys Prolactin II CalCheck 5 is substantially equivalent to otherproducts in commercial distribution intended for similar use. We claimequivalency to the cleared Elecsys DHEA-S CalCheck 5 (K103402). |
| DeviceDescription | The Elecsys Prolactin II CalCheck 5 is a lyophilized product consisting ofprolactin in an equine serum matrix. During manufacture, the analyte isspiked into the matrix at the desired concentration levels. |
| Intended use | The Elecsys Prolactin II CalCheck 5 is an assayed control for use incalibration verification and for use in the verification of the assay rangeestablished by the Elecsys Prolactin II 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 Prolactin II CalCheck 5 with the predicate Comparison Table device, Elecsys DHEA-S CalCheck 5 (K103402).
| Characteristic | Elecsys Prolactin II CalCheck 5 (Candidate Device) | Elecsys DHEA-S CalCheck 5 (K103402) |
|---|---|---|
| Intended Use | The Elecsys Prolactin II 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 Prolactin II reagent on the indicated Elecsys and cobas e immunoassay analyzers. | The Elecsys DHEA-S 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 DHEA-S reagent on the indicated Elecsys and cobas e immunoassay analyzers. |
| Analyte | Prolactin | DHEA-S |
| Levels | Five | Same |
| Format | Lyophilized | Same |
| Handling | Reconstitute Check 1, Check 2, Check 3, Check 4, and Check 5 with exactly 1.0 mL distilled or deionized water. Allow to stand closed for 15 minutes, then mix gently by inversion. | Same |
| Stability | Unopened:• Store at 2-8°C until expiration dateReconstituted:• 20-25°C: 4 hours | Unopened:• SameReconstituted:• Same |
| Matrix | Equine serum matrix | Human serum matrix |
Performance The Elecsys Prolactin II CalCheck 5 was evaluated for value assignment and Characteristics stability.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is an emblem of an eagle with its wings spread, symbolizing the department's role in protecting and promoting the health and well-being of the nation.
Re:
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
MAY 1 2 2011
Roche Diagnostics Corp. c/o Ms. Kelly Colleen O'Maine Adams Regulatory Affairs Consultant 9115 Hague Road, Bldg. A Indianapolis, Indiana 46250-0416
K110613 Trade Name: Elecsys Prolactin II Calcheck 5 Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed). Regulatory Class: I, reserved Product Codes: JJX Dated: March 02, 2011 Received: March 03, 2011
Dear Ms. O'Maine 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, 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); medical device 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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Page 2 -
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), 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 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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
C.C.
Courthey 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
KII0613 510(k) Number (if known):
Device Name: Elecsys Prolactin II CalCheck 5
Indication For Use:
The Elecsys Prolactin II 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 Prolactin II 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 (OVD)
Ous
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K-110613
§ 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.