(35 days)
The Elecsys C-Peptide CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the serum and plasma assay range established by the Elecsys C-Peptide reagent on the indicated Elecsys and cobas e immunoassay analyzers.
The Elecsys C-Peptide CalCheck 5 is a lyophilized product consisting of synthetic C-peptide in equine serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
The provided text is related to a 510(k) submission for the "Elecsys C-Peptide CalCheck 5," a quality control material. However, the document does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it include details about a clinical study, test set, ground truth, or training set mentioned in your request.
The document primarily focuses on:
- Administrative details: Submitter information, contact person, date prepared.
- Device identification: Proprietary name, common name, classification name, predicate device.
- Device description: Lyophilized product of synthetic C-peptide in equine serum matrix.
- Intended use: Assayed control for calibration verification and assay range verification for Elecsys C-Peptide reagent on Elecsys and cobas e immunoassay analyzers.
- Regulatory approval: FDA's 510(k) clearance letter, confirming substantial equivalence to a predicate device (K040157).
- Regulatory classification: Class I, reserved, product codes JJX.
Since the input text does not contain the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement, I cannot populate the table or answer the specific questions.
Therefore, I must state that the requested information is not available in the provided document.
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APR 2 6 2010
APR 2 6 2010
| 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 name, address, contact | Roche Diagnostics 9115 Hague Road, P.O. Box 50416 Indianapolis, IN 46250-0416 317-521-3577Contact Person: Kelly Colleen O'Maine Adams Phone: 317-521-3577 Fax: 317-521-2324 Email: colleen.adams@roche.comSecondary Contact: Stephanie Greeman Phone: 317-521-2458 Fax: 317-521-2324 Email: stephanie.greeman@roche.comDate Prepared: March 19, 2010 |
| Device Name | Proprietary name: Elecsys C-Peptide CalCheck 5 Common name: C-Peptide CalCheck 5 Classification name: Single (specified) analyte controls (assayed and unassayed) |
| Predicate device | The Elecsys C-Peptide CalCheck 5 is substantially equivalent to other products in commercial distribution intended for similar use. We claim equivalency to the currently marketed Elecsys C-Peptide CalCheck (K040157). |
| Device Description | The Elecsys C-Peptide CalCheck 5 is a lyophilized product consisting of synthetic C-peptide in equine serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels. |
| Intended use | The Elecsys C-Peptide CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the serum and plasma assay range established by the Elecsys C-Peptide reagent on the indicated Elecsys and cobas e immunoassay analyzers. |
| Continued on next page |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined strands representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Roche Diagnostics c/o Kelly Colleen O'Maine Adams Regulatory Affairs Consultant 9115 Hague Road P.O. Box 50416 Indianapolis, IN 46250-0416
APR 26 2010
Re: K100810
Trade Name: Elecsys C-Peptide 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: March 19, 2010 Received: March 22, 2010
Dear Mrs. 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 (OS) 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 reportiing 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 vours.
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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Indication for Use
510(k) Number (if known):
Device Name: Elecsys C-Peptide CalCheck 5
Indication For Use:
The Elecsys C-Peptide CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the serum and plasma assay range established by the Elecsys C-Peptide 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)
Carol C Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K100810
Page 1 of 1
§ 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.