(34 days)
The Elecsys N-MID Osteocalcin 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 N-MID Osteocalcin reagent on the indicated Elecsys and cobas e immunoassay analyzers.
The Elecsys N-MID Osteocalcin CalCheck 5 is a lyophilized product consisting of synthetic osteocalcin in a human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
The provided document is a 510(k) summary for the Elecsys N-MID Osteocalcin CalCheck 5. This device is a quality control material, and the provided text does not contain specific acceptance criteria, a study proving performance, or detailed information about test sets, ground truth establishment, or training sets in the way that would typically be described for a diagnostic device that detects or measures a specific condition in patient samples.
Instead, the document details the device's intended use, its comparison to a predicate device (another control material), and its stability. The evaluation of performance characteristics mentioned is related to "value Performance Characteristics assignment and stability," which refers to how accurately the control material's known values are established and maintained over time.
Therefore, many of the requested fields cannot be filled from the provided text, as they pertain to clinical or diagnostic studies that are not relevant to a quality control material's 510(k) submission in this context.
Here's an attempt to answer the questions based only on the provided information, noting where information is not available:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a numerical or categorical format for the device's performance in the way a diagnostic device would. It mentions "evaluation for value Performance Characteristics assignment and stability." The stability aspect has a specific reported performance.
| Acceptance Criteria Category (Implied from differences with predicate) | Reported Device Performance (from "Differences" section) |
|---|---|
| Intended Use | Not applicable here, as it's a description of function, not a performance metric. |
| Stability (Reconstituted at 20-25°C) | 5 hours |
| Analyte | Osteocalcin |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified for performance evaluation.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a control material with pre-determined concentrations (known values), not a diagnostic device requiring expert interpretation of results to establish ground truth.
4. Adjudication method for the test set
Not applicable.
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 study type is for diagnostic devices, particularly those involving human interpretation, often with AI assistance. This device is a quality control material.
6. 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.
7. The type of ground truth used
For a quality control material, the "ground truth" for its performance is its assigned value and its stability. The document states: "During manufacture, the analyte is spiked into the matrix at the desired concentration levels." This indicates the known concentrations are established during manufacturing.
8. The sample size for the training set
Not applicable. This device is a quality control material, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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| 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 46250-0416317-521-3501Contact Person: Jane Phillips, PhDPhone: 317-521-3338Fax: 317-521-2324Email: jane.phillips@roche.comSecondary Contact: Kelly Colleen O'Maine AdamsPhone: 317-521-3577Fax: 317-521-2324Email: colleen.adams@roche.comDate Prepared: July 15, 2011 | |
| Device Name | Proprietary name: Elecsys N-MID Osteocalcin CalCheck 5Common name: Osteocalcin CalCheck 5Classification name: Single (specified) analyte controls (assayed andunassayed) | |
| Predicatedevice | The Elecsys N-MID Osteocalcin CalCheck 5 is substantially equivalent toother products in commercial distribution intended for similar use. We claimequivalency to the cleared Elecsys DHEA-S CalCheck 5 (K103402). | |
| DeviceDescription | The Elecsys N-MID Osteocalcin CalCheck 5 is a lyophilized productconsisting of synthetic osteocalcin in a human serum matrix. Duringmanufacture, the analyte is spiked into the matrix at the desired concentrationlevels. | |
| Intended use | The Elecsys N-MID Osteocalcin CalCheck 5 is an assayed control for use incalibration verification and for use in the verification of the assay rangeestablished by the Elecsys N-MID Osteocalcin reagent on the indicatedElecsys and cobas e immunoassay analyzers. |
Continued on next page
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510(k) Summary, Continued
Comparison Table The table below compares Elecsys N-MID Osteocalcin CalCheck 5 with the predicate device, Elecsys DHEA-S CalCheck 5 (K103402).
| Characteristic | Elecsys N-MID OsteocalcinCalCheck 5 (Candidate Device) | Elecsys DHEA-S CalCheck 5(K103402) |
|---|---|---|
| Differences | ||
| Intended Use | The Elecsys N-MID OsteocalcinCalCheck 5 is an assayed control foruse in calibration verification andfor use in the verification of theassay range established by theElecsys N-MID Osteocalcin reagenton the indicated Elecsys and cobas eimmunoassay analyzers. | The Elecsys DHEA-S CalCheck 5 isan assayed control for use incalibration verification and for use inthe verification of the assay rangeestablished by the Elecsys DHEA-Sreagent on the indicated Elecsys andcobas e immunoassay analyzers. |
| Stability | Reconstituted:• 20-25°C: 5 hours | Reconstituted:• 20-25°C: 4 hours |
| Analyte | Osteocalcin | DHEA-S |
| Similarities | ||
| Levels | Five | Same |
| Format | Lyophilized | Same |
| Handling | Reconstitute Check 1, Check 2,Check 3, Check 4, and Check 5 withexactly 1.0 mL distilled or deionizedwater. Allow to stand closed for 15minutes, then mix gently byinversion. | Same |
| Matrix | Human serum matrix | Same |
| Stability | Unopened:• Store at 2-8°C until expirationdate | Unopened:• Same |
The Elecsys N-MID Osteocalcin CalCheck 5 was evaluated for value Performance Characteristics assignment and stability.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized depiction of an eagle or bird-like figure, with its wings forming a flowing, abstract shape.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Image /page/2/Picture/4 description: The image shows a date, AUG 2 5 2041, in bold black font. The month is abbreviated to AUG, followed by the day 2 and 5. The year is 2041. The date is likely extracted from a document or label.
Roche Diagnostics c/o Ms. Jane Ellen Phillips Program Manager, Regulatory Submissions 9115 Hague Road P.O. Box 50416 Indianapolis, IN 46250
Re: K112104 Trade Name: Elecsys N-MID Osteocalcin CalCheck 5 Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material Regulatory Class: Class I, reserved Product Codes: JJX Dated: July 21, 2011 Received: July 22, 2011
Dear Ms. Phillips,
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.
Courtney 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 N-MID Osteocalcin CalCheck 5
Indications for Use:
The Elecsys N-MID Osteocalcin 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 N-MID Osteocalcin reagent on the indicated Elecsys and cobas e immunoassay analyzers.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Officer
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K112104
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
§ 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.