(35 days)
Not Found
No
The document describes a control material for an immunoassay analyzer and does not mention any AI or ML components.
No
The device is described as an "assayed control for use in calibration verification and for use in the verification of the serum and plasma assay range," indicating it's used for quality control of immunoassay analyzers, not for treating a disease or condition.
No
The device is described as an assayed control for calibration verification and for verifying the assay range of a reagent. It is used to ensure the accuracy of other diagnostic devices, not to diagnose a condition itself.
No
The device description clearly states it is a "lyophilized product consisting of synthetic C-peptide in equine serum matrix," which is a physical substance, not software.
Based on the provided information, the Elecsys C-Peptide CalCheck 5 is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "calibration verification" and "verification of the serum and plasma assay range" for the Elecsys C-Peptide reagent on specific immunoassay analyzers. This indicates it's used in vitro (outside the body) to assess the performance of a diagnostic test.
- Device Description: It's a "lyophilized product consisting of synthetic C-peptide in equine serum matrix." This is a reagent or control material used in laboratory testing.
- Predicate Device: The mention of a predicate device (K040157; Elecsys C-Peptide CalCheck) which is also a CalCheck product, further supports its classification as an IVD. Predicate devices are typically other legally marketed IVDs.
The purpose of this device is to ensure the accuracy and reliability of an in vitro diagnostic test (the Elecsys C-Peptide assay). Therefore, it falls under the definition of an IVD.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
JJX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
.
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 317-521-3577 |
| 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 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 |
1
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).
2
Page 2
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
3
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