(93 days)
The Elecsys HCG STAT CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys HCG STAT reagent on the indicated Elecsys and cobas e immunoassay analyzers.
The Elecsys HCG STAT CalCheck 5 is a lyophilized product consisting of HCG in human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
The provided text describes the Elecsys HCG STAT CalCheck 5, a control solution used for calibration verification and assay range verification of the Elecsys HCG STAT reagent on specific immunoassay analyzers.
Here's an analysis of the acceptance criteria and supporting study details:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states, "The Elecsys HCG STAT CalCheck 5 was evaluated for value assignment." However, it does not explicitly define specific numerical acceptance criteria (e.g., target ranges, precision limits, deviation thresholds) for this "value assignment." Instead, it relies on the similarity of its formulation to a previously cleared device.
| Acceptance Criteria (Not explicitly stated in the document) | Reported Device Performance |
|---|---|
| Value Assignment: (Implied to be consistent and accurate for calibration verification and assay range verification) | "The Elecsys HCG STAT CalCheck 5 was evaluated for value assignment." (No specific performance data is provided beyond this statement). |
| Stability: (Implied to meet the same stability profiles as the predicate device) | "Because Elecsys HCG STAT CalCheck 5 formulation is identical to the Elecsys HCG+B CalCheck 5, the stability studies presented and cleared in the HCG+ ß CalCheck 5 submission, K092168, apply." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for the "value assignment" evaluation.
- Data Provenance: Not explicitly stated. Given that it's a control solution for in-vitro diagnostics, the "test set" would refer to the characteristics of the control material itself rather than patient samples. The information indicates the device was internally evaluated by Roche Diagnostics.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This type of information is generally not applicable to a control solution which is itself used to establish the "truth" of an assay's performance against known values. The "ground truth" for the control solution's own value assignment would be based on highly precise and accurate analytical methods, typically performed by expert analytical chemists or qualified laboratory personnel. The document does not specify the number or qualifications of individuals involved in the value assignment process.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods are typically employed in studies involving human interpretation or subjective assessments, which is not the case for the value assignment of an assayed control.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. MRMC studies compare the performance of human readers, sometimes with and without AI assistance, on diagnostic tasks. This device is an assayed control for an immunoassay, not a diagnostic imaging or interpretive AI device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a biochemical control solution, not an algorithm or AI system.
7. Type of Ground Truth Used
The "ground truth" for the Elecsys HCG STAT CalCheck 5 is its assigned HCG concentration values. These are established through:
- Analytical Methods: Precise and accurate laboratory measurements using reference methods or highly calibrated instruments.
- Manufacturing Specifications: The analyte is "spiked into the matrix at the desired concentration levels" during manufacture, indicating a known, engineered ground truth.
8. Sample Size for the Training Set
Not applicable. This device is a control solution, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
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MAR - 4 2010
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 Road, P.O. Box 50416Indianapolis, IN 46250-0416317-521-3577Contact Person: Kelly Colleen O'Maine AdamsPhone: 317-521-3577Fax: 317-521-2324Email: colleen.adams@roche.comSecondary Contact: Stephanie GreemanPhone: 317-521-2458Fax: 317-521-2324Email: stephanie.greeman@roche.comDate Prepared: November 30, 2009 | |
| Device Name | Proprietary name: Elecsys HCG STAT CalCheck 5Common name: HCG STAT CalCheck 5Classification name: Single (specified) analyte controls (assayed andunassayed) | |
| Predicatedevice | The Elecsys HCG STAT CalCheck 5 is substantially equivalent to otherproducts in commercial distribution intended for similar use. We claimequivalency to the currently marketed Elecsys HCG+β CalCheck 5(K092168). | |
| DeviceDescription | The Elecsys HCG STAT CalCheck 5 is a lyophilized product consisting ofHCG in human serum matrix. During manufacture, the analyte is spiked intothe matrix at the desired concentration levels. | |
| Intended use | The Elecsys HCG STAT CalCheck 5 is an assayed control for use incalibration verification and for use in the verification of the assay rangeestabalished by the Elecsys HCG STAT reagent on the indicated Elecsys andcobas e immunoassay analyzers. | |
| Continued on next page |
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510(k) Summary, Continued
The table below compares Elecsys HCG STAT CalCheck 5 with the predicate Comparison Table device, Elecsys HCG+B Calcheck 5 (K092168). .
| Characteristic | Elecsys HCG+β CalCheck 5(K092168) | Elecsys HCG STAT CalCheck 5 |
|---|---|---|
| Intended Use | The Elecsys HCG+β CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys HCG+β reagent on the indicated Elecsys and cobas e immunoassay analyzers. | The Elecsys HCG STAT CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys HCG STAT reagent on the indicated Elecsys and cobas e immunoassay analyzers. |
| Levels | Five | Five |
| Format | Lyophilized | Lyophilized |
| Handling | Reconstitute Check 1, Check 2, Check 3, Check 4, and Check 5 with exactly 1.0 mL distilled or deionized water. Allow to stand closed for 15 minutes, then mix gently by inversion. | Same |
| Stability | Unopened:• Store at 2-8°C until expiration dateReconstituted:• 20 – 25°C : 4 hrs | Same |
| Matrix | Human serum matrix | Same |
Performance Characteristics
The Elecsys HCG STAT CalCheck 5 was evaluated for value assignment. Because Elecsys HCG STAT CalCheck 5 formulation is identical to the Elecsys HCG+B CalCheck 5, the stability studies presented and cleared in the HCG+ ß CalCheck 5 submission, K092168, apply
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Image /page/2/Picture/0 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" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird-like figure, composed of three parallel, curved lines.
Roche Diagnostics Corp c/o Kelly C. O'Maine Adams 9115 Hague Road PO Box 50410 Indianapolis, Indiana 46250-0416 Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
MAR 0 4 2010
K093700 Re:
Trade Name: ELECYS HCG STAT CALCHECK 5 Regulation Number: 21 CFR §862.1660 Regulation Name: Calibrator. Regulatory Class: Class I Product Codes: JJX Dated: February 8, 2010 Received: February 12, 2010
Dear Ms. Adams:
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Signature
Courtney C. Harper, Ph.D. 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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Indication for Use
510(k) Number (if known):
i o937vr2
Device Name: Elecsys HCG STAT CalCheck 5
Indication For Use:
The Elecsys HCG STAT CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys HCG STAT reagent on the indicated Elecsys and cobas e immunoassay analyzers.
Prescription Use _ X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use __ (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K 093700
Page I of I
§ 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.