(36 days)
Not Found
No
The summary describes a lyophilized calibration product for an immunoassay analyzer, with no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is described as a lyophilized product for verifying the calibration of reagents and immunoassay analyzers, indicating it is a quality control material for diagnostic tests rather than a device intended to treat or alleviate a disease or condition.
No
The device is described as a calibrator used for the "verification of the calibration established by the Elecsys proBNP II reagent", not for diagnosing a condition in a patient.
No
The device description explicitly states it is a "lyophilized product" consisting of physical components (serum, matrix). This indicates it is a physical reagent, not a software-only device.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's "For use in the verification of the calibration established by the Elecsys proBNP II reagent on the Elecsys and cobas e immunoassay analyzers." This indicates it's used in vitro (outside the body) to assess the performance of another diagnostic test (the Elecsys proBNP II reagent).
- Device Description: The description mentions it's a "lyophilized product consisting of NT-proBNP (1-76) amide human serum and potassium phosphate buffered matrix." This is a typical format for a control or calibrator used in laboratory testing.
- Function: The function described is to "verify the calibration," which is a crucial step in ensuring the accuracy and reliability of an in vitro diagnostic test.
While it doesn't directly diagnose a disease, it is an essential component used in vitro to ensure the proper functioning of a diagnostic test. This falls squarely under the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For use in the verification of the calibration established by the Elecsys proBNP II reagent on the Elecsys and cobas e immunoassay analyzers.
Product codes
JJX
Device Description
The Elecsys proBNP II CalCheck is a lyophilized product consisting of NT-proBNP (1-76) amide human serum and potassium phosphate buffered matrix. During manufacture, the analytes are 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
The Elecsys proBNP II CalCheck was evaluated for value assignment and stability.
Key Metrics
Not Found
Predicate Device(s)
Elecsys ProBNP CalCheck (K020883)
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
510(k) Summary
FEB 27 2009 -
| 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 Indianapolis, IN 46250 317-521-2458 |
| Contact Person: Kay A. Taylor | |
| Date Prepared: January 18, 2008 | |
| Device Name | Proprietary name: Elecsys proBNP II CalCheck |
| Common name: proBNP II CalCheck | |
| Classification name: Single (specified) analyte controls (assayed and unassayed) | |
| Predicate device | The Elecsys proBNP II CalCheck is substantially equivalent to other products in commercial distribution intended for similar use. We claim equivalency to the currently marketed Elecsys ProBNP CalCheck (K020883). |
| Device Description | The Elecsys proBNP II CalCheck is a lyophilized product consisting of NT-proBNP (1-76) amide human serum and potassium phosphate buffered matrix. During manufacture, the analytes are spiked into the matrix at the desired concentration levels. |
| Intended use | For use in the verification of the calibration established by the Elecsys proBNP II reagent on the Elecsys and cobas e immunoassay analyzers. |
| Continued on next page |
.
1
510(k) Summary, Continued
The table below compares Elecsys proBNP II CalCheck with the predicate Comparison Table device, Elecsys ProBNP CalCheck (K020883).
. . . . .
| Characteristic | Elecsys proBNP CalCheck
(Predicate) | Elecsys proBNP II CalCheck |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For use in the verification of the
calibration established by the
Elecsys proBNP reagent on the
indicated Elecsys and cobas e
immunoassay analyzers. | For use in the verification of the
calibration established by the Elecsys
proBNP II reagent on the Elecsys and
cobas e immunoassay analyzers. |
| Levels | Three | same |
| Format | Lyophilized | same |
| Handling | Reconstitute with exactly 1.0 mL
distilled or deionized water and allow
standing closed for 15 minutes, then
mixing gently. | Reconstitute with exactly 1.0 mL
distilled or deionized water and allow
standing closed for 15 minutes, then
mixing gently. |
| Stability | Unopened:
· Store at 2-8℃ until expiration date
Reconstituted:
● 20-25℃:4 hrs | same |
| Matrix | Level 1: NT-proBNP free human
serum matrix
Levels 2/3: synthetic NT-proBNP in
human serum / buffer matrix | same |
The Elecsys proBNP II CalCheck was evaluated for value assignment and Performance Characteristics stability.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 2 7 2008
Roche Diagnostics c/o Ms. Kay Taylor, (ASCP) Regulatory Affairs Principal 9115 Hague Road P.O. Box 50416 Indianapolis, IN 46250-0416
K080147 Re:
Trade Name: Elecsys proBNP II CalCheck Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I reserved Product Code: JJX Dated: January 18, 2008 Received: January 22, 2008
Dear Ms. Taylor:
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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Yean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indication for Use - Elecsys proBNP II CalCheck
510(k) Number (if known):
2080147
Device Name: Elecsys proBNP II CalCheck
Indication For Use:
For use in the verification of the calibration established by the Elecsys proBNP II reagent on the Elecsys and cobas e immunoassay analyzers.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.
Prescription Use XXX (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 (OIVD)
Signature
Divisign Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K080147