(141 days)
The Elecsys CA 19-9 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 19-9 reagent on the indicated Elecsys and cobas e immunoassay analyzers. For in vitro diagnostic use only.
The Elecsys CA 19-9 CalCheck 5 is a lyophilized product consisting of human CA 19-9 in human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
This document describes the Elecsys CA 19-9 CalCheck 5, an assayed control for use in calibration verification and assay range verification for the Elecsys CA 19-9 reagent on Elecsys and cobas e immunoassay analyzers.
Here's an analysis based on the provided text, addressing your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a quantitative manner for the performance study. Instead, it states that the device "was evaluated for value assignment and stability." The reported performance is the established "Check Target Values" for each of the five levels of the CalCheck. These values essentially act as the performance targets that the control material is designed to demonstrate when used with the Elecsys CA 19-9 reagent.
Since specific performance metrics like accuracy, precision, or recovery rates against acceptance limits are not provided in the summary, the table below reflects what is available.
| Characteristic | Acceptance Criteria / Target | Reported Device Performance |
|---|---|---|
| Check Targets (U/mL) | ||
| Check 1 | ≤ 3 U/mL | Established as ≤ 3 U/mL |
| Check 2 | 35 U/mL | Established as 35 U/mL |
| Check 3 | 500 U/mL | Established as 500 U/mL |
| Check 4 | 800 U/mL | Established as 800 U/mL |
| Check 5 | 1000 U/mL | Established as 1000 U/mL |
| Stability (Unopened) | Store at 2-8°C | Store at 2-8°C until expiration date |
| Stability (Reconstituted) | 20-25°C: 4 hours | 20-25°C: 4 hours |
| Format | Lyophilized | Lyophilized |
| Matrix | Human serum matrix | Human serum matrix |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the sample size used for the performance evaluation of value assignment and stability. It also does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given the nature of a 510(k) summary for an in vitro diagnostic control, it's highly likely to be prospective testing performed by the manufacturer, but this is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. For a control material like this, the "ground truth" (i.e., the target values) would typically be established through highly precise and accurate measurement methods by the manufacturer during the production and analytical characterization of the control lots, rather than by external experts in the same way, for instance, a diagnostic imaging AI might use clinical experts.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. The development of target values for a quality control material involves robust analytical methods and statistical analysis by the manufacturer, not a consensus or adjudication process involving multiple external experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human interpretation is involved (e.g., radiology AI). The Elecsys CA 19-9 CalCheck 5 is an in vitro diagnostic control material, and its performance is assessed analytically, not through human reader interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not directly applicable in the terms usually associated with AI or imaging devices. The Elecsys CA 19-9 CalCheck 5 itself is a physical control material, not an algorithm. Its performance is assessed as a standalone product (i.e., its ability to yield expected results when measured by the Elecsys CA 19-9 assay) in laboratory settings. The document states it was "evaluated for value assignment and stability," which implies such standalone analytical performance testing was conducted.
7. The Type of Ground Truth Used
The "ground truth" for the Elecsys CA 19-9 CalCheck 5 is the assigned target values for each of its five levels, along with its established stability characteristics. These values are determined by the manufacturer (Roche Diagnostics) through their internal analytical methods and quality control processes during the development and manufacturing of the control material. It is a form of analytical reference standard determination.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical control material, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
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K 101367
バ
| 510(k) Summary | OCT - |
|---|---|
| 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 46250-0416317-521-3577 |
| Contact Person: Kelly Colleen O'Maine AdamsPhone: 317-521-3577Fax: 317-521-2324Email: colleen.adams@roche.com | |
| Secondary Contact: Stephanie GreemanPhone: 317-521-2458Fax: 317-521-2324Email: stephanie.greeman@roche.com | |
| Date Prepared: September 27, 2010 | |
| Device Name | Proprietary name: Elecsys CA 19-9 CalCheck 5Common name: CA 19-9 CalCheck 5Classification name: Single (specified) analyte controls (assayed andunassayed) |
| Predicatedevice | The Elecsys CA 19-9 CalCheck 5 is substantially equivalent to other productsin commercial distribution intended for similar use. We claim equivalency tothe currently marketed Elecsys C-Peptide CalCheck 5 (K100810) and CA 19-9 CalCheck (K051185). |
| DeviceDescription | The Elecsys CA 19-9 CalCheck 5 is a lyophilized product consisting ofhuman CA 19-9 in human serum matrix. During manufacture, the analyte isspiked into the matrix at the desired concentration levels. |
| Intended use | The Elecsys CA 19-9 CalCheck 5 is an assayed control for use in calibrationverification and for use in the verification of the assay range established bythe Elecsys CA 19-9 reagent on the indicated Elecsys and cobas eimmunoassay analyzers. For in vitro diagnostic use only. |
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510(k) Summary, Continued
Comparison The table below compares Elecsys CA 19-9 CalCheck 5 with the predicate Table devices, Elecsys C-Peptide CalCheck 5 (K100810) and CA 19-9 CalCheck (K051185). The first predicate shows that CA 19-9 CalCheck 5 is substantially equivalent to another CalCheck 5 product, Elecsys C-Peptide CalCheck 5. The Elecsys CA 19-9 CalCheck 5 is also substantially equivalent to the second predicate, CA 19-9 CalCheck, with several key similarities, especially the analyte. The shaded fields indicate similar characteristics between the candidate device and one or both predicate devices.
| Characteristic | Elecsys C-PeptideCalCheck 5 (K100810) | Elecsys CA 19-9CalCheck 5(Candidate Device) | Elecsys CA 19-9CalCheck(K051185) |
|---|---|---|---|
| Intended Use | The Elecsys C-PeptideCalCheck 5 is an assayedcontrol for use in calibrationverification and for use inthe verification of the serumand plasma assay rangeestablished by the ElecsysC-Peptide reagent on theindicated Elecsys and cobase immunoassay analyzers. | The Elecsys CA 19-9Calcheck 5 is an assayedcontrol for use incalibration verification andfor use in the verificationof the assay rangeestablished by the ElecsysCA 19-9 reagent on theindicated Elecsys andcobas e immunoassayanalyzers. For in vitrodiagnostic use only. | For use in the verification ofthe calibration established bythe Elecsys CA 19-9 reagenton the indicated Elecsys andcobas e immunoassayanalyzers. |
| Analyte | C-Peptide | CA 19-9 | CA 19-9 |
| Levels | Five | Five | Three |
| Assay MeasuringRange | 0.1 - 40 ng/mL | 0.600 - 1000 U/mL | 0.600 - 1000 U/mL |
| Check TargetValues | Check 1: <0.2 ng/mLCheck 2: 5.0 ng/mLCheck 3: 20 ng/mLCheck 4: 30 ng/mLCheck 5: 40 ng/mL | Check 1: ≤ 3U/mLCheck 2: 35 U/mLCheck 3: 500 U/mLCheck 4: 800 U/mLCheck 5: 1000 U/mL | Check 1: < 5 U/mLCheck 2: 179 U/mLCheck 3: 676 U/mL |
| Format | Lyophilized | Lyophilized | Lyophilized |
| Handling | Reconstitute Check 1, Check2. Check 3, Check 4, andCheck 5 with exactly 1.0 mLdistilled or deionized water.Allow to stand closed for 15minutes, then mix gently byinversion. | Reconstitute Check 1,Check 2, Check 3, Check4, and Check 5 withexactly 1.0 mL distilled ordeionized water. Allow tostand closed for 15minutes, then mix gentlyby inversion. | Reconstitute Check 1, Check2, and Check 3 with exactly1.0 mL distilled or deionizedwater. Allow to stand closedfor 15 minutes, then mixgently by inversion. |
| Stability | Unopened:• Store at 2-8°C untilexpiration dateReconstituted:• 20-25°C: 4 hours | Unopened:• Store at 2-8°C untilexpiration dateReconstituted:• 20-25°C: 4 hours | Unopened:• Store at 2-8°C untilexpiration dateReconstituted:• 20-25°C: 4 hours |
| Matrix | Equine serum matrix | Human serum matrix | Human serum matrix |
Continued on next page
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Performance Characteristics The Elecsys CA 19-9 CalCheck 5 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 and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
Roche Diagnostics c/o Ms. Kelly Colleen O'Maine Adams, MTSC Regulatory Affairs Consultant 9115 Hague Road P.O.Box 50416 Indianapolis, IN, 46250-0416
OCT 0 5 2010
Re: K101365
Trade/Device Name: Elecsys CA 19-9 CalCheck 5 Regulation Number: 21 CFR§862.1660 Regulation Name: Quality Control Material, Assayed and Unassayed Regulatory Class: Class I (Reserved) Product Code: JJX Dated: August 27, 2010 Received: August 31, 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 class II (Special Controls), 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
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Page 2 – Ms. Kelly Colleen O'Maine Adams
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). 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 advice for your device on our labeling regulation (21 CFR Parts 801 and 809), 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 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/cdrh/industry/support/index.html.
Sincerely yours,
for Maria M. Chan, Ph.D.
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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Indication for Use
OCT - 5 2010
510(k) Number (if known): Ќю( 36 S
Device Name: Elecsys CA 19-9 CalCheck 5
Indication For Use:
The Elecsys CA 19-9 CalCheck 5 is an assayed control for use in callbration verification and for use in the verification of the assay range established by the Elecsys CA 19-9 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 (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)
Reena Philip
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K101365
§ 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.