(118 days)
Not Found
No
The summary describes a lyophilized control product for immunoassay analyzers, with no mention of AI or ML in the intended use, device description, or specific sections for AI/ML mentions.
No.
The device is described as an assayed control for calibration verification and assay range verification for a reagent on immunoassay analyzers, indicating it is an in-vitro diagnostic (IVD) device used for quality control, not for treating a disease or condition.
No
This device is described as an "assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys Folate III reagent." It is used to verify the proper functioning and calibration of diagnostic instruments (Elecsys and cobas e immunoassay analyzers) and reagents, rather than directly diagnosing a patient's condition.
No
The device description explicitly states it is a "lyophilized product consisting of Folate in human serum matrix," indicating it is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "calibration verification and for use in the verification of the assay range established by the Elecsys Folate III reagent on the indicated Elecsys and cobas e immunoassay analyzers." This describes a product used in vitro (outside the body) to assess the performance of a diagnostic test.
- Device Description: The description mentions it's a "lyophilized product consisting of Folate in human serum matrix." This is a common format for IVD controls and calibrators, designed to mimic biological samples for testing purposes.
- Context: The device is designed to be used with "Elecsys and cobas e immunoassay analyzers," which are themselves IVD instruments used for performing diagnostic tests on biological samples.
Therefore, based on its intended use and description, the Elecsys Folate III CalCheck 5 fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Elecsys Folate III 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 Folate III reagent on the indicated Elecsys and cobas e immunoassay analyzers.
Product codes
JJX
Device Description
The Elecsys Folate III CalCheck 5 is a lyophilized product consisting of Folate in human 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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K0940531
APR 2 7 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: December 29, 2009 | |
| Device Name | Proprietary name: Elecsys Folate III CalCheck 5 |
| Common name: Folate CalCheck 5 | |
| Classification name: Single (specified) analyte controls (assayed and unassayed) | |
| Predicate | |
| device | The Elecsys Folate III CalCheck 5 is substantially equivalent to other products in commercial distribution intended for similar use. We claim equivalency to the currently marketed Elecsys HCG+β CalCheck 5 (K092168). |
| Device | |
| Description | The Elecsys Folate III CalCheck 5 is a lyophilized product consisting of Folate in human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels. |
| Intended use | The Elecsys Folate III 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 Folate III reagent on the indicated Elecsys and cobas e immunoassay analyzers. |
| Continued on next page |
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Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services (HHS) in the USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
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 2 7 2010
K094031 Re:
Trade Name: Elecsys Folate III CalCheck 5 Regulation Number: 21 CFR 8862,1660 Regulation Name: Quality Control Material (assayed and unassayed) Regulatory Class: Class I. Reserved Product Codes: JJX Dated: March 10, 2010 Received: March 11, 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 (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 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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
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
3
Indication for Use
510(k) Number (if known):
Device Name: Elecsys Folate III CalCheck 5
Indication For Use:
The Elecsys Folate III 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 Folate III 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 Benson
Division Sign Off
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K094031
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