(15 days)
For use in the verification of the calibration established by the Elecsys Folate II reagent on the Elecsys 2010 and MODULAR ANALYTICS E170 immunoassay analyzers.
The Elecsys Folate II CalCheck II is a set of calibration verification solutions comprised of three levels, each with defined folate levels.
This is a 510(k) premarket notification for a calibration verification material, not a device that requires performance metrics like accuracy, sensitivity, or specificity against clinical data. Therefore, many of the requested elements (like sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable in the context of this submission.
The "acceptance criteria" for a calibration verification material typically relate to its ability to verify the calibration of an analyzer within expected performance parameters, often demonstrated by comparing its performance to a legally marketed predicate device.
Here's the closest interpretation of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a predicate device. The performance is assessed by confirming that the new device functions similarly in its intended use as a calibration verification material.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (Elecsys® Folate II CalCheck II) |
|---|---|
| Intended Use / Indications for Use: Verification of calibration for Elecsys® Folate assay on Elecsys 2010 and MODULAR ANALYTICS E170. | For use in the verification of the calibration established by the Elecsys® Folate II reagent on the Elecsys 2010 and MODULAR ANALYTICS E170 immunoassay analyzers. (Matches) |
| Matrix: Buffer with human albumin | Human serum (Different, but typical for immunoassay calibration verification materials, and likely considered acceptable) |
| Storage Form: Liquid | Lyophilized (Different, common for these types of materials for stability, and likely considered acceptable) |
| Levels: Defined low, mid, and high folate levels consistent with calibration verification. | Low: 2.0 ng/mlMid: 7.5 ng/mlHigh: 15.3 ng/ml (Comparable to predicate levels, but not identical) |
| Standardization: Against Elecsys Folate assay, which was standardized against a commercially available radiobinding folate assay. | The Elecsys Folate II assay has been standardized against the Elecsys Folate assay. (Similar standardization hierarchy) |
| Stability: Store at 2-8°C unopened up to expiration date; Opened: 5 hours at 20-25°C. | Same (Matches) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided text. For a calibration verification material, the "test set" would typically involve running the material on the specified immunoassay analyzers multiple times to assess its performance against expected values and ensure it behaves as a control. The text does not provide this specific study detail.
- Data Provenance: Not explicitly stated (e.g., country of origin). The submission is from Roche Diagnostics in Indianapolis, IN, USA. The nature of the device (calibration material) suggests internal validation data.
- Retrospective or Prospective: Not specified. Performance evaluations of calibration materials are typically prospective, as they involve testing the manufactured product.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Experts: Not applicable. For a calibration verification material, the "ground truth" (i.e., the target folate levels) is established during the manufacturing and standardization process of the material itself, not through expert consensus on interpretation.
- Qualifications of Experts: N/A
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no diagnostic interpretation involved that would require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- MRMC Study: No. This is a calibration verification material, not a diagnostic imaging or interpretive device that would benefit from an MRMC study.
- Effect Size of Human Readers Improve with AI vs without AI assistance: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. This device is a material used as part of a larger immunoassay system; it does not operate as a standalone algorithm.
7. The Type of Ground Truth Used
- Ground Truth Type: For a calibration verification material, the "ground truth" is typically the assigned value (concentration) for each level of the material, established through a rigorous standardization process traceable to primary reference materials or methods. In this case, it's stated that the Elecsys Folate II assay was standardized against the Elecsys Folate assay, which in turn was standardized against a commercially available radiobinding folate assay.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is a manufactured material, not a machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable.
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DEC 17 2004
510(k) Summary - Elecsys® Folate II CalCheck II
| 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 Diagnostics9115 Hague RdIndianapolis IN 46250(317) 521-3544 |
| Contact person: Kay A. Taylor | |
| Date prepared: December 1, 2004 | |
| Device Name | Proprietary name: Roche Diagnostics Elecsys® Folate II CalCheck II |
| Common name: Calibration Verification Material | |
| Classification name: Single (specified) Analyte Controls (Assayed and Unassayed) | |
| Device description | The Elecsys Folate II CalCheck II is a set of calibration verification solutions comprised of three levels, each with defined folate levels. |
| Intended use | For use in the verification of the calibration established by the Elecsys Folate II reagent on the Elecsys 2010 and MODULAR ANALYTICS E170 immunoassay analyzers. |
| Predicate Device | We claim substantial equivalence to the currently marketed Elecsys Folate CalCheck. (K974384). |
| Device Comparison | The table below illustrates the similarities between the Elecsys Folate CalCheck (K974384) and the Elecsys Folate II CalCheck II (modified device). |
...
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510(k) Summary - Elecsys® Folate II CalCheck II, continued
:
| Topic | Elecsys® Folate CalCheck(K974384) | Elecsys® Folate II CalCheck II(Modified Device) |
|---|---|---|
| Intended Use /Indications forUse | For use in the verification of thecalibration established by the... Elecsys Folate reagent on theElecsys 2010 Elecsys Folate II reagent on theMODULAR ANALYTICS E170. | For use in the verification of thecalibration established by the ElecsysFolate II reagent on the Elecsys 2010and MODULAR ANALYTICS E170immunoassay analyzers. |
| Matrix | Buffer with human albumin | Human serum |
| Storage Form | Liquid | Lypholized |
| Levels | Low: 1.5 ng/mlMid: 8.7 ng/mlHigh: 16.0 ng/ml | Low: 2.0 ng/mlMid: 7.5 ng/mlHigh:15.3 ng/ml |
| Standardization | The Elecsys Folate II assay has beenstandardized against the ElecsysFolate assay. The Elecsys Folateassay was standardized against acommercially available radiobindingfolate assay. Note: the previously usedradiobinding folate assay is no longeravailable. | The Elecsys Folate II assay has beenstandardized against the ElecsysFolate assay. |
| Stability | Store at 2-8°C unopened up to theexpiration date.Opened: 5 hours at 20-25°C | Same |
24
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle in a circular fashion.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 17 2004
Ms. Kay A. Taylor, MT (ASCP), RAC Regulatory Principal Roche Diagnostics Corp. Centralized Diagnostics 9115 Hague Road Indianapolis, IN 46250
K043320 Re:
Trade/Device Name: Roche Elecsys Folate II CalCheckII Regulation Number: 21 CFR 862.1660 Regulation Name: Control Material Regulatory Class: Class I Product Code: JJX Dated: December 1, 2004 Received: December 2, 2004
Dear Ms. Taylor:
We have reviewed your Section 510(k) premarket notification of intent to market the device w one reviewed your we 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 (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,
Sincerely yours,
Cornelia B. Lorks
Cornelia B. Rooks, MA Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K043320
Device Name: Roche Elecsys Folate II CalCheck II
Indications For Use:
For use in the verification of the calibration established by the Elecsys Folate II reagent on the Elecsys 2010 and MODULAR ANALYTICS E170 immunoassay analyzers.
Prescription Use XXX (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C. Benson
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of __
510(k) K043320
§ 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.