(33 days)
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.
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.
The provided 510(k) summary for the Elecsys® C-Peptide CalCheck describes a quality control material intended for use in verifying the calibration of the Elecsys® C-Peptide reagent on Elecsys® immunoassay systems.
It is important to note that this submission is for a Class I medical device (quality control material), which typically has different performance evaluation requirements compared to diagnostic algorithms using AI. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the analytical performance characteristics of the control material (value assignment and stability) rather than the clinical performance of a diagnostic algorithm.
Based on the provided documents, here's the information requested:
1. A table of acceptance criteria and the reported device performance
The document mentions "Performance Characteristics: The Elecsys® C-Peptide CalCheck was evaluated for value assignment and stability." However, specific quantitative acceptance criteria (e.g., % recovery, stability limits) and the detailed reported performance data are not explicitly provided in the excerpt. The submission focuses on establishing substantial equivalence to a predicate device (Elecsys® SHBG CalCheck) based on characteristics like intended use, levels, format, handling, and stability, rather than detailing the analytical validation results of C-Peptide CalCheck itself.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the excerpt. For a quality control material, a "test set" would typically refer to the number of lots or units tested for value assignment and stability studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable/provided for this type of device. The "ground truth" for a quality control material is its assigned value, which is determined through an analytical process by the manufacturer, not by expert consensus in the typical sense of diagnostic image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable/provided for this type of device. Adjudication methods are typically used in clinical studies involving interpretation by multiple readers/experts.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC comparative effectiveness study is not applicable for this device. This type of study is relevant for diagnostic devices (especially those involving AI or human interpretation) to assess reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The Elecsys® C-Peptide CalCheck is a physical quality control material, not a diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a quality control material, the "ground truth" for its assigned value is established through rigorous analytical methods and reference measurements by the manufacturer leading to a "value assignment." This would involve multiple measurements on characterized reference instruments/methods, likely performed by trained laboratory personnel, rather than expert clinical consensus or pathology.
8. The sample size for the training set
This is not applicable. As a quality control material, there is no "training set" in the context of machine learning or AI models.
9. How the ground truth for the training set was established
This is not applicable.
{0}------------------------------------------------
FEB 2 5 2004
510(k) Summary
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence. |
|---|---|
| Submittername, address,contact | Roche Diagnostics9115 Hague RoadIndianapolis, IN 46250317-521-3723 |
| 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 andunassayed) | |
| Predicatedevice | The Elecsys® C-Peptide CalCheck is substantially equivalent to the currentlymarketed Elecsys® SHBG CalCheck (K031698). |
| DeviceDescription | The Elecsys® C-Peptide CalCheck is a lyophilized product consisting ofsynthetic human C-Peptide in a buffered equine serum matrix. Duringmanufacture, the analytes are spiked into the matrix at the desiredconcentration levels. |
| Intended use | The Elecsys® C-Peptide CalCheck is intended for use in the verification ofthe calibration established by the Elecsys® C-Peptide reagent on theElecsys® 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-PeptideCalCheck | Predicate device:Elecsys® SHBGCalCheck |
|---|---|---|
| Intended Use | Elecsys® C-PeptideCalCheck is intended foruse in the verification ofthe calibrationestablished by theElecsys® C-Peptidereagent on the Elecsys®immunoassay systems. | Elecsys® SHBG CalCheckis intended for use in theverification of thecalibration established bythe Elecsys® SHBGreagent on the Elecsys®immunoassay systems. |
| Levels | Three | same |
| Format | Lyophilized | same |
| Handling | Reconstitute with exactly1.0 mL distilled waterand allow to stand closedfor 15 minutes. | same |
| Stability | Unopened:• Store at 2-8°C untilexpiration dateReconstituted:• 20 – 25 °C : 4 hrs | same |
Continued on next page
{2}------------------------------------------------
510(k) Summary, Continued
Differences
| Characteristic | Elecsys® C-PeptideCalCheck | Predicate device:Elecsys® SHBGCalCheck |
|---|---|---|
| Matrix | Buffered horse serumwith added C-Peptide. | Buffered horse serum andhuman serum with addedSHBG |
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
§ 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.