(98 days)
The Elecsys CA 125 II 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 CA 125 II reagent on the indicated Elecsys and cobas e immunoassay analyzers, for in vitro diagnostic use only.
The Elecsys CA 125 II CalCheck 5 is a lyophilized product consisting of equine serum in level 1 and human serum matrix for levels 2-5. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
The provided text describes a 510(k) submission for the Elecsys CA 125 II CalCheck 5, a device intended for calibration verification and assay range verification in immunoassay analyzers. The document focuses on demonstrating substantial equivalence to predicate devices rather than reporting on a study with acceptance criteria in the manner typically seen for clinical diagnostic devices that provide patient-specific results.
Therefore, the requested information elements related to clinical study design, ground truth establishment, expert adjudication, MRMC studies, and training set information are not applicable in this context, as this submission is for a quality control material and not a diagnostic algorithm. The "performance characteristics" section is very brief and refers to "value assignment" and "stability," which are typically internal validation metrics for quality control materials.
Here's the breakdown of the information as it relates to the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state numerical acceptance criteria in the format typically seen for diagnostic performance (e.g., sensitivity, specificity, AUC). Instead, it relies on demonstrating substantial equivalence to existing predicate devices based on shared characteristics and intended use. The "Performance Characteristics" section merely states: "The Elecsys CA 125 II CalCheck 5 was evaluated for value assignment and stability."
The comparison table implies equivalence based on similar design, intended use, format, handling, and stability characteristics with the predicate devices.
| Characteristic | Acceptance Criteria (Implied by Predicate Equivalence) | Elecsys CA 125 II CalCheck 5 Performance (as reported) |
|---|---|---|
| Intended Use | Substantially equivalent to predicates (calibration verification, assay range verification for CA 125 II reagent on Elecsys/cobas e analyzers). | "The Elecsys CA 125 II 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 CA 125 II reagent on the indicated Elecsys and cobas e immunoassay analyzers, for in vitro diagnostic use only." (Matches predicate K100810 in intent, and predicate K003967 in analyte) |
| Analyte | CA 125 (matching predicate K003967) | CA 125 |
| Levels | Five (matching predicate K100810) | Five |
| Format | Lyophilized (matching both predicates) | Lyophilized |
| Handling | Reconstitution with 1.0mL water, stand for 15 min, gently invert (similar to both predicates) | Reconstitution with 1.0mL water, stand for 15 min, gently invert |
| Stability (Unopened) | Store at 2-8°C until expiration date (matching both predicates) | Store at 2-8°C until expiration date |
| Stability (Reconstituted) | 20-25°C: 4 hours (matching both predicates) | 20-25°C: 4 hours |
| Matrix | Equine serum (Level 1), Human serum (Levels 2-5) (similar to both predicates' variations) | Level 1: Equine serum; Levels 2-5: Human serum matrix |
| Performance (general) | Must demonstrate appropriate "value assignment" and "stability" for a quality control material. | "The Elecsys CA 125 II CalCheck 5 was evaluated for value assignment and stability." (Specific data not provided in this summary but would be in the full submission). |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable as the document describes a 510(k) submission for a quality control material, not a clinical diagnostic device requiring a "test set" from patient data. The "evaluation" for value assignment and stability would involve a series of laboratory experiments on the manufacturing lots of the CalCheck 5 product itself. The provenance of such data would be internal to the manufacturer (Roche Diagnostics).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable. The concept of "ground truth" derived from expert consensus is typically relevant for diagnostic devices that interpret patient results (e.g., imaging devices, pathology slides). For a quality control material, "ground truth" (or target values) for analyte concentration are established through a robust value assignment process using reference methods and calibrated instruments, overseen by internal experts in analytical chemistry and quality control, not clinical experts for diagnostic interpretation.
4. Adjudication Method for the Test Set
This is not applicable for the same reasons as #3. Adjudication is relevant for resolving discrepancies in expert interpretations of diagnostic findings, which is not pertinent to the evaluation of a quality control material.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers' Improvement with AI vs. Without AI Assistance
This is not applicable. MRMC studies are used to evaluate the diagnostic performance of devices, especially those involving human interpretation, and are particularly relevant for AI-assisted diagnostic tools. The Elecsys CA 125 II CalCheck 5 is a quality control product, not a diagnostic device, and does not involve human readers interpreting cases or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
This is not applicable. This device is a biochemical control material, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for a quality control material like Elecsys CA 125 II CalCheck 5 would be the assigned target values for CA 125 concentration at each of the five levels, determined through rigorous analytical methods using reference standards and calibrated instruments. This is an analytical/chemical ground truth, not a clinical one (like pathology, expert consensus on images, or patient outcomes).
8. The Sample Size for the Training Set
This is not applicable. The device is a quality control material and does not involve an AI algorithm with a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as #8.
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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 Roche Diagnostics name, address, 9115 Hague Road, P.O. Box 50416 contact Indianapolis, IN 46250-0416 317-521-3501 Contact Person: Kelly French Phone: 317-521-3208 Fax: 317-521-2324 Email: kelly.french@roche.com Secondary Contact: Stephanie Greeman Phone: 317-521-2458 Fax: 317-521-2324 Email: stephanie.greeman@roche.com Date Prepared: June 30, 2010 Device Name Proprietary name: Elecsys CA 125 II CalCheck 5 Common name: CA 125 II CalCheck 5 Classification name: Single (specified) analyte controls (assayed and unassayed) Predicate The Elecsys CA 125 II CalCheck 5 is substantially equivalent to other device products in commercial distribution intended for similar use. We claim equivalency to the currently marketed Elecsys C-Peptide CalCheck 5 (K100810) and the Elecsys CA 125 II CalCheck (K003967). Device The Elecsys CA 125 II CalCheck 5 is a lyophilized product consisting of Description · equine serum in level 1 and human serum matrix for levels 2-5. During manufacture, the analyte is spiked into the matrix at the desired concentration levels. Intended use The Elecsys CA 125 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 CA 125 II reagent on the indicated Elecsys and cobas e immunoassay analyzers, for in vitro diagnostic use only.
510(k) Summary
NOV - 1 2010
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Comparison Table The table below compares Elecsys CA 125 CalCheck 5 with the predicate devices, Elecsys C-Peptide CalCheck 5 (K100810) and the CA 125 II CalCheck (K003967).
Please note that the use of two predicates has been utilized for this submission based on previous FDA feedback to several of the most recently FDA-cleared CalCheck 5 products. The first predicate shows that the CA 125 II CalCheck 5 is substantially equivalent to another CalCheck 5 product. The Elecsys CA 125 II CalCheck 5 is also substantially equivalent to the second predicate, CA 125 II CalCheck, with several key similarities, especially the analyte. The shaded fields indicate similar characteristics between the candidate device and a predicate device.
| Characteristic | Elecsys C-PeptideCalCheck 5 (K100810) | Elecsys CA 125 II CalCheck5(Candidate Device) | Elecsys CA 125 II CalCheck(K003967) |
|---|---|---|---|
| Intended Use | The Elecsys C-Peptide CalCheck5 is an assayed control for use incalibration verification and foruse in the verification of theserum and plasma assay rangeestablished by the ElecsysC-Peptide reagent on the.indicated Elecsys and cobas eimmunoassay analyzers. | The Elecsys CA 125 II Calcheck5 is an assayed control for use incalibration verification and foruse in the verification of theassay range established by theElecsys CA 125 II reagent on theindicated Elecsys and cobas eimmunoassay analyzers, for invitro diagnostic use only. | For use in verification of thecalibration established by theElecsys CA 125 II reagent on theElecsys 2010 and 1010Immunoassay analyzers. |
| Analyte | C-Peptide | CA 125 | CA 125 |
| Levels | Five | Five | Three |
| Format | Lyophilized | Same | Same |
| Handling | Reconstitute Check 1, Check 2,Check 3, Check 4, and Check 5with exactly 1.0 mL distilled ordeionized water. Allow to standclosed for 15 minutes, then mixgently by inversion. | Reconstitute Check 1, Check 2,Check 3, Check 4, and Check 5with exactly 1.0 mL distilled ordeionized water. Allow to standclosed for 15 minutes, then mixgently by inversion. | Reconstitute Check 1, Check 2,and Check 3 with exactly 1.0 mLdistilled or deionized water.Allow to stand closed for 15minutes, then mix gently byinversion. |
| Stability | Unopened:• Store at 2-8°C until expirationdateReconstituted:• 20-25°C: 4 hours | Unopened:• Store at 2-8°C until expirationdateReconstituted:• 20-25°C: 4 hours | Unopened:• Store at 2-8°C until expirationdateReconstituted:• 20-25°C: 4 hours |
| Matrix | Equine serum matrix | Level 1: Equine serumLevels 2-5: Human serum matrix | Level 1: Equine serumLevels 2 & 3: Human serummatrix |
Performance Characteristics
The Elecsys CA 125 II CalCheck 5 was evaluated for value assignment and stability.
: ..............................................................................................................................................................................
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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 consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circle around the eagle. The text is in all caps and is relatively small compared to the eagle symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993-0002
Roche Diagnostics c/o Ms. Kelly French Regulatory Affairs Consultant Roche Professional Diagnostics 9115 Hague Road P.O. Box 50416 Indianapolis, IN 46250-0416
NOV 0 1 2010
Re: K102086
Trade/Device Name: Elecsys CA 125II CalCheck 5 Regulation Number: 21CFR 8862.1660 Regulation Name: Quality control material, assayed and unassayed Regulatory Class: Class I (Reserved) Product Code: JJX Dated: October 8, 2010 Received: October 12, 2010
Dear Ms. French:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 net 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
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Page 2 – Ms Kelly French
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/ReportalProblem/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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/medicaldevices/resourcesforindustry/default.htm
Sincerely yours,
Tharai Im Chen
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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K102086 510(k) Number (if known):
NOV 0 1 2010
Device Name: Elecsys CA 125 II CalCheck 5
Indication For Use:
The Elecsys CA 125 II 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 CA 125 II reagent on the indicated Elecsys and cobas e immunoassay analyzers, for in vitro diagnostic use only.
Prescription Use _ X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use __ i (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 (OIVD)
Bema Philip
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K102086
Page 1 of 1
§ 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.