(27 days)
Elecsys® PreciControl Anemia is used for quality control of the Elecsys® Ferritin, Folate II, and Vitamin B12 immunoassays on the Elecsys® immunoassay systems.
The Elecsys® PreciControl Anemia is a lyophilized product consisting of added Ferritin and Aprotinine in human serum matrix. During manufacture, the analytes are spiked into the matrix at the desired concentration levels.
The provided 510(k) summary (K051517) describes a quality control device, Elecsys® PreciControl Anemia, for in-vitro diagnostic immunoassays. It is not a device that would typically involve acceptance criteria related to disease detection or diagnosis based on patient data, nor would it involve studies with human readers or ground truth established by experts in the context of diagnostic accuracy.
The acceptance criteria and supporting "study" for a quality control product are focused on its ability to perform consistently and provide expected values for the assays it controls.
Here's an interpretation based on the provided document and the typical evaluation of such devices:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "The Elecsys® PreciControl Anemia was evaluated for value assignment and Performance Characteristics stability." This indicates that the "acceptance criteria" for this device would revolve around:
- Accuracy of Value Assignment: The assigned values for Ferritin, Folate II, and Vitamin B12 in the control material must be within specified ranges and precisely determined.
- Stability: The control material must maintain its assigned values over time under various storage conditions (unopened, reconstituted at different temperatures, after freezing/thawing).
- Matrix Compatibility: The control's matrix (human serum) must be appropriate for the target immunoassays.
The document does not explicitly list quantitative acceptance criteria values or detailed performance data in the provided snippets. This level of detail is typically found in the full 510(k) submission or internal validation reports, not usually summarized in this specific section of the public summary.
However, based on the intent of the provided information, the table would look conceptually like this:
| Acceptance Criteria Category | Specific Criteria (Conceptual, Not Explicitly Stated in Provided Text) | Reported Device Performance (Conceptual, Not Explicitly Stated in Provided Text) |
|---|---|---|
| Value Assignment | Assigned values for analytes (Ferritin, Folate II, B12) must be within manufacturer-defined target ranges with a specified precision. | Values were successfully assigned for all analytes and levels. (Implied by the device being cleared). |
| Accuracy/Traceability | Assigned values should be traceable to reference methods or materials demonstrating accuracy. | Values are traceable and accurate for the intended assays. (Implied). |
| Unopened Stability | Control retains assigned values when stored at 2-8°C until expiration date. | Device demonstrated stability at 2-8°C until expiration. |
| Reconstituted Stability | Control retains assigned values for specified durations at various temperatures (e.g., 20-25°C, 2-8°C, -20°C). | Device demonstrated stability as outlined in the "Stability" section (e.g., 8 hrs at 20-25°C, 3 days at 2-8°C). |
| Freeze-Thaw Stability | Control retains assigned values after one freeze-thaw cycle. | Stable after one freeze-thaw cycle. |
| Matrix Compatibility | The control matrix (human serum) must not interfere with or negatively impact the performance of the Elecsys® immunoassays. | Compatible with the Elecsys® immunoassay systems. (Implied by intended use). |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "The Elecsys® PreciControl Anemia was evaluated for value assignment and Performance Characteristics stability." This implies a series of laboratory experiments.
- Test Set Sample Size: For a quality control material, the "sample size" would refer to the number of batches/lots of the product manufactured and tested, and the number of replicates run during stability and value assignment studies. This information is not provided in the summary. It would typically involve multiple lots tested at various time points and temperature conditions.
- Data Provenance: The studies would have been conducted by Roche Diagnostics, likely in their internal laboratories. The document does not specify the country of origin or if it's retrospective/prospective, but for a new product validation, these would be controlled, prospective laboratory studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This concept is not applicable to this type of device. The "ground truth" for a quality control material is its precisely assigned analyte concentration. This is established through rigorous laboratory methods, often traceable to international reference standards, rather than expert consensus on clinical images or patient outcomes.
4. Adjudication Method for the Test Set
This concept is not applicable. Adjudication methods (like 2+1 or 3+1) are used to resolve discrepancies in expert interpretations of clinical data or images. For a quality control material, analytical results are quantitative and objective within the measurement system's precision.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
This concept is not applicable. MRMC studies are used to evaluate the impact of a diagnostic aid (like AI) on physician performance. The Elecsys® PreciControl Anemia is a quality control reagent, not a diagnostic aid that human readers would use in clinical decision-making.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This concept is not applicable. This is a quality control material, not an algorithm.
7. The Type of Ground Truth Used
For a quality control material, the "ground truth" is established by:
- Assigned Values: The manufacturer meticulously determines the precise concentration of the target analytes (Ferritin, Folate II, Vitamin B12) in the control material. This often involves:
- Using highly accurate reference methods.
- Traceability to international reference materials or standards (if available).
- Extensive testing across multiple instruments and laboratories to ensure reproducibility and consistency.
- Analytical Performance Data: The "ground truth" for its performance would be the quantitative analytical results from experiments demonstrating that the control maintains its assigned values under specified conditions and performs as expected within the Elecsys® immunoassay systems.
8. The Sample Size for the Training Set
This concept is not applicable. The Elecsys® PreciControl Anemia is a chemical reagent, not a learning algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
This concept is not applicable as there is no "training set" for this device.
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| JUL | 5 - 2005 |
|---|---|
| ----- | ---------- |
and the comments of the comments of the comments of the contraction of the contribution of the contribution of the contribution of the contribution of the contribution of the
K 05/5/17
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 Diagnostics9115 Hague RoadIndianapolis, IN 46250317-521-3723Contact Person: Corina HarperDate Prepared: Jun 6, 2005 |
| Device Name | Proprietary name: Elecsys® PreciControl AnemiaCommon name: PreciControl AnemiaClassification name: The FDA has classified Multi-Analyte Controls, All Kinds (assayed and unassayed) in Class I. |
| Predicate device | The Elecsys® PreciControl Anemia is substantially equivalent to the currently marketed Elecsys® PreciControl MultiAnalyte (K033937). |
| Device Description | The Elecsys® PreciControl Anemia is a lyophilized product consisting of added Ferritin and Aprotinine in human serum matrix. During manufacture, the analytes are spiked into the matrix at the desired concentration levels. |
| Intended use | Elecsys® PreciControl Anemia is used for quality control of the Elecsys® Ferritin, Folate II, and Vitamin B12 immunoassays on the Elecsys® immunoassay systems. |
| Continued on next page |
:
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510(k) Summary, Continued
| Comparison to The Elecsys® PreciControl Anemia is substantially equivalent to the | |
|---|---|
| predicate device | currently marketed Elecsys® PreciControl MultiAnalyte (K033937). The |
| below tables compare Elecsys® PreciControl Anemia with the predicate device, Elecsys® PreciControl MultiAnalyte (K033937). |
Similarities
| Characteristic | Elecsys® PreciControlAnemia | Predicate DeviceElecsys® PreciControlMultiAnalyte(K033937) |
|---|---|---|
| Intended Use | Elecsys® PreciControlAnemia is used for qualitycontrol of the Elecsys®Ferritin, Folate II, andVitamin B12 immunoassayson the Elecsys®immunoassay systems. | Elecsys® PreciControlMultiAnalyte is used forquality control of the Elecsys®C-Peptide and Elecsys Insulinimmunoassays on theElecsys® immunoassaysystems. |
| Levels | Three | Two |
| Format | Lyophilized | same |
| Handling | Reconstitute with exactly 2.0mL of distilled water andallow to stand closed for 30minutes to reconstitute, andthen mix gently. | Reconstitute with exactly 2.0mL of distilled water and allowto stand closed for 15 minutesto reconstitute, and then mixgently. |
| Stability | Unopened:• Store at 2-8°C untilexpiration dateReconstituted:• 20 - 25 °C: up to 8 hrs• on the analyzers at 20-25°C: up to 5 hrs• at 2-8°C: 3 days• at -20°C: 1 month (freezeonly once)• after thawing: use onlyonce | Unopened:• Store at 2-8°C untilexpiration dateReconstituted:• on the analyzers at 20-25°C:up to 3 hrs• at -20°C: 1 month (freezeonly once)• after thawing: use only once |
Continued on next page
Roche Diagnostics Confidential
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510(k) Summary, Continued
| Characteristic | Elecsys® PreciControlAnemia | Predicate DeviceElecsys® PreciControlMultiAnalyte(K033937) |
|---|---|---|
| Matrix | Human serum with addedFerritin (human origin) andAprotinine (bovine origin) | Equine serum with addedC-Peptide and insulin |
The Elecsys® PreciControl Anemia was evaluated for value assignment and Performance Characteristics 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 eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Public Health Service
Ms. Corina Harper, RAC Regulatory Affairs Consultant Centralized Diagnostics Roche Diagnostics 9115 Hague Road PO Box 50416 Indianapolis, IN 46250-0416
JUL 5 - 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Re: K051517
Trade/Device Name: Elecsys® PreciControl Anemia Regulation Number: 21 CFR 862.1660 Regulation Name: Multi-Analyte controls all kinds (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: June 6, 2005 Received: June 8, 2005
Dear Ms. Harper:
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 vour 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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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 (240) 276-0484. 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/industry/support/index.html.
Sincerely yours,
Carol C. Benam
Carol C. Benson, M.A. 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): K051517
Device Name:
Elecsys® PreciControl Anemia
Indications For Use:
Elecsys® PreciControl Anemia is used for quality control of the Elecsys® Ferritin, Folate II, and Vitamin B12 immunoassays on the Elecsys® immunoassay systems.
Prescription Use XXXX (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 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)
K
(Division Sign-Off)
Division of Clinical Laboratory Devices 510(k) Number
Roche Diagnostics Confidential
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§ 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.