(33 days)
Not Found
No
The summary describes a calibration check product for an immunoassay system, which is a chemical reagent used to verify the accuracy of the system's measurements. There is no mention of AI or ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is a calibrator for an immunoassay system, used to verify the calibration of a reagent. It does not directly treat or diagnose a disease.
No.
The device is a "CalCheck" product intended for the verification of calibration of a reagent on immunoassay systems, not for diagnosing a disease or condition in a patient.
No
The device description explicitly states it is a "lyophilized product consisting of synthetic human C-Peptide in a buffered equine serum matrix," indicating it is a physical substance, not software.
Based on the provided information, the Elecsys® C-Peptide CalCheck is not an IVD (In Vitro Diagnostic) device itself, but rather a calibration verification material used with an IVD device.
Here's why:
- Intended Use: The intended use clearly states it's for "verification of the calibration established by the Elecsys® C-Peptide reagent on the Elecsys® immunoassay systems." This indicates its role is to check the accuracy of another diagnostic test (the Elecsys® C-Peptide reagent).
- Device Description: It's described as a "lyophilized product consisting of synthetic human C-Peptide in a buffered equine serum matrix." This is a control or calibrator material, not a device that directly performs a diagnostic test on a patient sample.
- Predicate Device: The predicate device listed is "Elecsys® SHBG CalCheck," which is also a calibration verification material. This further supports its classification as a calibration product rather than a diagnostic device.
In summary: The Elecsys® C-Peptide CalCheck is a crucial component for ensuring the accuracy of the Elecsys® C-Peptide reagent (which is an IVD), but it is not an IVD device itself. It's a quality control material used in the IVD testing process.
N/A
Intended Use / Indications for Use
The Elecsys® C-Peptide CalCheck is intended for use in the verification of the calibration established by the Elecsys® C-Peptide reagent on the Elecsys® immunoassay systems.
Product codes
JJX
Device Description
The Elecsys® C-Peptide CalCheck is a lyophilized product consisting of synthetic human C-Peptide in a buffered equine serum 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® C-Peptide CalCheck was evaluated for value assignment and stability.
Key Metrics
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
FEB 2 5 2004
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
Indianapolis, IN 46250
317-521-3723 |
| | Contact Person: Theresa M. Ambrose |
| | Date Prepared: January 22, 2004 |
| Device Name | Proprietary name: Elecsys® C-Peptide CalCheck |
| | Common name: C-Peptide CalCheck |
| | Classification name: Single (specified) analyte controls (assayed and
unassayed) |
| Predicate
device | The Elecsys® C-Peptide CalCheck is substantially equivalent to the currently
marketed Elecsys® SHBG CalCheck (K031698). |
| Device
Description | The Elecsys® C-Peptide CalCheck is a lyophilized product consisting of
synthetic human C-Peptide in a buffered equine serum matrix. During
manufacture, the analytes are spiked into the matrix at the desired
concentration levels. |
| Intended use | The Elecsys® C-Peptide CalCheck is intended for use in the verification of
the calibration established by the Elecsys® C-Peptide reagent on the
Elecsys® immunoassay systems. |
| | Continued on next page |
| Comparison to | The Elecsys® C-Peptide CalCheck is substantially equivalent to the currently |
| predicate | marketed Elecsys® SHBG CalCheck (K031698). The below tables compare |
| device | Elecsys® C-Peptide CalCheck with the predicate device, Elecsys® SHBG |
| | CalCheck (K031698). |
1
510(k) Summary, Continued
Similarities
| Characteristic | Elecsys® C-Peptide
CalCheck | Predicate device:
Elecsys® SHBG
CalCheck |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Elecsys® C-Peptide
CalCheck is intended for
use in the verification of
the calibration
established by the
Elecsys® C-Peptide
reagent on the Elecsys®
immunoassay systems. | Elecsys® SHBG CalCheck
is intended for use in the
verification of the
calibration established by
the Elecsys® SHBG
reagent on the Elecsys®
immunoassay systems. |
| Levels | Three | same |
| Format | Lyophilized | same |
| Handling | Reconstitute with exactly
1.0 mL distilled water
and allow to stand closed
for 15 minutes. | same |
| Stability | Unopened:
• Store at 2-8°C until
expiration date
Reconstituted:
• 20 – 25 °C : 4 hrs | same |
Continued on next page
2
510(k) Summary, Continued
Differences
| Characteristic | Elecsys® C-Peptide
CalCheck | Predicate device:
Elecsys® SHBG
CalCheck |
|----------------|-----------------------------------------------|------------------------------------------------------------|
| Matrix | Buffered horse serum
with added C-Peptide. | Buffered horse serum and
human serum with added
SHBG |
Performance Characteristics The Elecsys® C-Peptide CalCheck was evaluated for value assignment and stability.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a representation of the human form, with three figures connected at the base.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 2 5 2004
Theresa M. Ambrose, Ph.D. Regulatory Principal Centralized Diagnostics Regulatory Submissions Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457
Re: K040157
Trade/Device Name: Elecsys® C-Peptide CalCheck Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: January 22, 2004 Received: January 23, 2004
Dear Dr. Ambrose:
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).
4
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 (301) 594-3084. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Jean M. Cooper, MS, DVM.
Yean M. Cooper, MS, 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
5
Indications for Use Statement
K040157 510(k) Number (if known): N/A
Device Name: Elecsys® C-Peptide CalCheck
Indications For Use:
The Elecsys® C-Peptide CalCheck is intended for use in the verification of the calibration The Liccsys® C-Peptide reagent on the Elecsys® immunoassay systems.
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Carol C Benson
Division Sign Off
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K040157