(19 days)
The Elecsys® PreciControl MultiAnalyte is used for quality control of the Elecsys C-Peptide and Elecsys Insulin immunoassays on the Elecsys immunoassay systems.
The Elecsys® PreciControl MultiAnalyte is a lyophilized product consisting of synthetic human C-Peptide and recombinant human insulin in a buffered equine serum matrix. During manufacture, the analytes are spiked into the matrix at the desired concentration levels.
The provided text describes the Elecsys® PreciControl MultiAnalyte, a quality control material, and its substantial equivalence to a predicate device. However, the document does NOT contain information about specific acceptance criteria for performance metrics (such as sensitivity, specificity, or accuracy) or a detailed study proving the device meets particular criteria. Instead, it focuses on comparing the new device to a predicate device for regulatory purposes.
Therefore, many of the requested sections about acceptance criteria, study design, and performance metrics cannot be directly extracted from the provided text.
Here's a breakdown of what can be extracted and what cannot, based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not specify quantitative acceptance criteria (e.g., specific thresholds for accuracy, precision, or other performance metrics). It only states that the device "was evaluated for value assignment and stability" under "Performance Characteristics," but does not report the results of these evaluations or against what specific criteria they were judged.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Cannot be provided. The document does not mention any test sets, sample sizes, or data provenance for performance evaluation.
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)
- Cannot be provided. The concept of "ground truth" established by experts in the context of diagnostic performance studies is not applicable to this document, which describes a quality control material rather than a diagnostic device requiring such evaluation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Cannot be provided. This information is not relevant to the type of device described (quality control material) and is not present in the document.
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
- Cannot be provided. This is irrelevant to the device described, which is a quality control material, not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. This is irrelevant as the device is a quality control material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Cannot be provided. As explained in point 3, the concept of "ground truth" in this context is not applicable. The device is a control to ensure the accuracy of other immunoassays.
8. The sample size for the training set
- Cannot be provided. There is no mention of a "training set" as this is not an algorithm being developed.
9. How the ground truth for the training set was established
- Cannot be provided. There is no training set mentioned.
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JAN - 7 2004
| JAN - 7 2004 | |
|---|---|
| 510(k) Summary K033937 | |
| 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 Corporation9115 Hague RoadIndianapolis, IN 46250317-521-3723Contact Person: Theresa M. AmbroseDate Prepared: December 18, 2003 |
| Device Name | Proprietary name: Elecsys® PreciControl MultiAnalyteCommon name: PreciControl MultiAnalyteClassification name: Multi-analyte Controls (assayed and unassayed) |
| Predicate device | The Elecsys® PreciControl MultiAnalyte is substantially equivalent to the currently marketed Elecsys® PreciControl Cardiac (K032089). |
| Device Description | The Elecsys® PreciControl MultiAnalyte is a lyophilized product consisting of synthetic human C-Peptide and recombinant human insulin in a buffered equine serum matrix. During manufacture, the analytes are spiked into the matrix at the desired concentration levels. |
| Intended use | The Elecsys® PreciControl MultiAnalyte is used for quality control of the Elecsys C-Peptide and Elecsys Insulin immunoassays on the Elecsys immunoassay systems. |
| Continued on next page |
:
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510(k) Summary, Continued
The Elecsys® PreciControl MultiAnalyte is substantially equivalent to the Comparison to predicate currently marketed Elecsys® PreciControl Cardiac (K032089).The below device tables compare Elecsys® PreciControl MultiAnalyte with the predicate device, Elecsys® PreciControl Cardiac (K032089).
Similarities
. 7
| Characteristic | Elecsys®PreciControlMultiAnalyte | Predicate deviceElecsys® PreciControlCardiac |
|---|---|---|
| Intended Use | PreciControlMultiAnalyte is usedfor quality control ofthe Elecsys C-Peptideand Elecsys Insulinimmunoassays on theElecsys immunoassaysystems. | PreciControl Cardiac isused for quality controlof the Elecsys CK-MB,Digoxin, Myoglobin,and NT-proBNPimmunoassays on theElecsys immunoassaysystems. |
| Levels | Two | Same |
| Format | Lyophilized | Same |
| Handling | Reconstitute withexactly 2.0 mL distilledwater and allow tostand closed for 15minutes. | Same |
Continued on next page
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510(k) Summary, Continued
Differences
្រុះ
| Characteristic | Elecsys®PreciControlMultiAnalyte | Predicate deviceElecsys® PreciControlCardiac |
|---|---|---|
| Matrix | Equine serum withadded C-Peptide andinsulin | Human serum withadded CK-MB,digoxin, myoglobin,and NT-proBNP |
| Stability | Unopened:• Store at 2-8°C untilexpiration dateReconstituted:• At -20°C : 1 months• On the analyzers : 3 hrs | Unopened:• Store at 2-8°C untilexpiration dateReconstituted:• At 2-8°C : 3 days• At -20°C : 3 months• On the analyzers : 3 hrs |
Performance Characteristics
The Elecsys® PreciControl MultiAnalyte was evaluated for value assignment and stability.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized depiction of an eagle or bird-like figure, with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN - 7 2004
Theresa M. Ambrose, Ph.D. Regulatory Principal Roche Diagnostics Corporation 9115 Hague Road PO Box 50457 Indianapolis, IN 46250-0457
K033937 Re:
Trade/Device Name: Elecsys® PreciControl MultiAnalyte Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: December 18, 2003 Received: December 19, 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 for association to May 28, 1976, the enactment date of the Medical Device Amendments, or to commerce prices 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). and Oosmeter for ( ro ) re re re, subject to the general controls provisions of the Act. The r ou may, atteres 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 your de roo subject to such additional controls. Existing major regulations affecting your device it may be subject to back and Federal Regulations (CFR), Parts 800 to 895. In addition, I'DA 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 or any I 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 (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,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): N/A K 0339 37
Device Name: Elecsys® PreciControl MultiAnalyte
Indications For Use:
The Elecsys® PreciControl MultiAnalyte is used for quality control of the Elecsys C-Peptide and Elecsys Insulin immunoassays on the Elecsys immunoassay systems.
Prescription Use (Per 21 CFR 801 409)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Carl Bensen
Division Sign Off
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)_E033937
§ 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.