(60 days)
Not Found
No
The summary describes a calibration set for an immunoassay, which is a chemical reagent product, not a software or hardware device that would typically incorporate AI/ML. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
No
The device is a calibrator for an immunoassay system, used to ensure the accuracy of C-Peptide measurements, not to treat a condition or disease.
No
The device is a calibrator for an immunoassay system, used to ensure the accuracy of a quantitative assay. It specifically states its use is "for calibrating the quantitative C-Peptide assay," not for diagnosing conditions.
No
The device description clearly states it is a "lyophilized product consisting of synthetic human C-Peptide in a buffered horse serum matrix," indicating it is a physical reagent, not software.
Based on the provided information, the Elecsys® C-Peptide CalSet is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states it's used for calibrating a quantitative C-Peptide assay on Elecsys immunoassay systems. Immunoassay systems are used to perform in vitro diagnostic tests.
- Device Description: It's a product containing synthetic human C-Peptide in a matrix, designed to be used with an immunoassay system. This aligns with the nature of calibrators used in IVD testing.
- Performance Studies: The mention of performance studies for "value assignment and stability" is typical for IVD calibrators, which need to be accurately characterized for their intended use in diagnostic testing.
- Predicate Device: The predicate device listed (Elecsys® LH CalSet II) is also a calibrator for an immunoassay system, further supporting the classification of the Elecsys® C-Peptide CalSet as an IVD.
While the document doesn't explicitly state "In Vitro Diagnostic" in the intended use, the context of its function (calibrating an assay on an immunoassay system) and the nature of the device strongly indicate it falls under the definition of an IVD. Calibrators are essential components of many IVD tests, ensuring the accuracy and reliability of the results obtained from patient samples.
N/A
Intended Use / Indications for Use
The Elecsys® C-Peptide CalSet is used to calibrate the quantitative Elecsys C-Peptide assay on the Elecsys immunoassay systems.
Product codes (comma separated list FDA assigned to the subject device)
JIX
Device Description
The Elecsys® C-Peptide CalSet is a lyophilized product consisting of synthetic human C-Peptide in a buffered horse 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)
The Elecsys® C-Peptide CalSet was evaluated for value assignment and stability.
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
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
FEB 1 3 2004
く、
| 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 Corporation |
| 9115 Hague Road | |
| Indianapolis, IN 46250 | |
| 317-521-3723 |
Contact Person: Theresa M. Ambrose
Date Prepared: December 12, 2003 |
| Device Name | Proprietary name: Elecsys® C-Peptide CalSet
Common name: Calibrator
Classification name: Calibrator, secondary |
| Predicate
device | The Elecsys® C-Peptide CalSet is substantially equivalent to the currently
marketed Elecsys® LH CalSet II (K031299). |
| Device
Description | The Elecsys® C-Peptide CalSet is a lyophilized product consisting of
synthetic human C-Peptide in a buffered horse serum matrix. During
manufacture, the analyte is spiked into the matrix at the desired concentration
levels. |
| Intended use | The Elecsys® C-Peptide CalSet is used to calibrate the quantitative Elecsys
C-Peptide assay on the Elecsys immunoassay systems. |
1
510(k) summary, continued
い
| Comparison to
predicate | The Elecsys® C-Peptide CalSet is substantially equivalent to the currently
marketed Elecsys® LH CalSet II (K031299). The below tables compare |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| device | Elecsys® C-Peptide CalSet with the predicate device, Elecsys® LH CalSet II |
| Similarities | |
| Characteristic | Elecsys® C-Peptide
CalSet | Predicate device
Elecsys® LH CalSet II |
|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Intended Use | For calibrating the
quantitative Elecsys C-
Peptide assay on the
Elecsys immunoassay
systems. | For calibrating the
quantitative Elecsys LH
assay on the Elecsys
immunoassay systems. |
| Levels | Two | Same |
| Format | Lyophilized | Same |
| Handling | Add exactly 1.0 mL
distilled water and
allow to stand closed
for 15 minutes to
reconsititute. Mix
carefully, avoiding the
formation of foam. | Same |
Differences
| Characteristic | Elecsys® C-Peptide
CalSet | Predicate device
Elecsys® LH CalSet II |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Matrix | Equine serum with
added synthetic human
C-peptide | Human serum with
added human LH |
| Stability | Unopened:
• Store at 2-8°C until
expiration date
Reconstituted:
• -20°C : 1 month
(freeze only once)
• On the analyzers: use
only once | Unopened:
• Store at 2-8°C until
expiration date
Reconstituted:
• -20°C : 3 months
(freeze only once)
• On the analyzers: use
only once |
Performance Characteristics
The Elecsys® C-Peptide CalSet was evaluated for value assignment and stability.
21
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 1 3 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: K033873
Trade/Device Name: Elecsys® C-Peptide CalSet Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: December 12, 2003 Received: December 15, 2003
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).
3
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
4
Indications for Use Statement
510(k) Number (if known): N/A
Device Name: Elecsys® C-Peptide CalSet
Indications For Use:
The Elecsys® C-Peptide CalSet is used for calibrating the quantitative C-Peptide assay on the Elecsys immunoassay systems.
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use _
(Optional Format 1-2-96)
Alberto Sati'
Revision Sign-Off
Office of In Vitro Diagnostic Device _valuation and Safety
10(k) K 033873