(69 days)
PreciControl Tumor Marker is used for quality control of Elecsys immunoassays on Elecsys immunoassay systems. The controls are used for monitoring the accuracy and precision of Elecsys immunoassays.
PreciControl Tumor Marker contains lyophilized control serum based on human serum. The concentrations are in two clinically relevant ranges. The controls are used for monitoring the accuracy and precision of Elecsys immunoassays.
The provided text does not contain detailed information about acceptance criteria or a specific study proving the device meets those criteria. It is a 510(k) summary for a quality control material (Elecsys® PreciControl Tumor Marker), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting analytical accuracy or clinical performance studies of the device being controlled.
Therefore, many of the requested sections regarding study design, sample sizes, ground truth establishment, and MRMC studies cannot be answered from the provided text.
Here's the information that can be extracted or deduced from the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a performance study for a diagnostic device. Instead, it describes characteristics of the control material and compares them to a predicate device to establish substantial equivalence.
| Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance |
|---|---|---|
| Intended Use | Quality control for Elecsys immunoassays using Elecsys immunoassay systems (Elecsys 2010, 1010, and other Elecsys family instruments). | Quality control for Elecsys immunoassays on Elecsys immunoassay systems. (Stated as similar to predicate). |
| Analyzer System | Elecsys® immunoassay analyzers | Same |
| Reagent Format | Lyophilized, based on human serum | Same |
| Analyte Concentration (PC TM1 / PC TM2) | AFP: approx. 8 & 100 IU/mlCEA: approx. 5 & 50 ng/mlCA 15-3 II: approx. 20 & 100 U/mLCA 125 II: approx. 35 & 100 U/mLFerritin: approx. 25 & 200 ng/mLfPSA: approx. 1 & 10 ng/mLtPSA: approx. 4 & 40 ng/mL | AFP: approx. 8 & 100 IU/mlCEA: approx. 5 & 50 ng/mlCA 15-3 II: approx. 20 & 100 U/mLCA 125 II: approx. 35 & 100 U/mLFerritin: approx. 25 & 200 ng/mLfPSA: approx. 1 & 10 ng/mLtPSA: approx. 4 & 40 ng/mLCA 19-9: approx. 20 & 100 U/mL (Added to modified device) |
| Stability | @ 2-8° C: unopened until expiration date, opened for 2 weeks. @ 20-25° C: on analyzers up to 5 hours, 24 hours. @ -20° C: 1 month (freeze only once). | Same (with slight rephrasing: "1 month (freeze only once) months at -20° C (only freeze once)" which appears to be a typo/redundancy in the original text, but implies the same stability). |
The key difference highlighted is the addition of CA 19-9 to the analyte concentration list for the modified device. For the other parameters, the device performance is reported as "Same" or very similar to the predicate, indicating it meets the implied "acceptance criteria" of being substantially equivalent to the previously cleared device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The 510(k) pertains to a quality control material and focuses on demonstrating substantial equivalence, not on a performance study of the control material's ability to diagnose or monitor a condition. Therefore, there's no mention of a "test set" in the context of patient samples or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not provided. The device is a quality control material. Ground truth in the context of diagnostic accuracy for patient samples is not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable and not provided. The device is a quality control material, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. The device is a quality control material, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable and not provided. As a quality control material, the "ground truth" would refer to the assigned target values for the analytes within the control. The method for establishing these target values is not detailed, but typically involves a reference method or consensus of methods for the specific analytes.
8. The sample size for the training set
This information is not applicable and not provided. The concept of a "training set" is not relevant for a quality control material whose substantial equivalence is being demonstrated.
9. How the ground truth for the training set was established
This information is not applicable and not provided.
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510(k) Summary - Elecsys® PreciControl Tumor Marker
| 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 Diagnostics Corporation9115 Hague RdIndianapolis IN 46250(317) 521-3831 |
| Contact person: Kay A. Taylor | |
| Date prepared: February 14, 2005 | |
| Device Name | Proprietary name: Roche Diagnostics Elecsys® PreciControl Tumor Marker |
| Common name: Quality Control Material | |
| Classification name: Multi-analyte Controls (assayed and unassayed) | |
| Device description | PreciControl Tumor Marker contains lyophilized control serum based on human serum. The concentrations are in two clinically relevant ranges. The controls are used for monitoring the accuracy and precision of Elecsys immunoassays. |
| Intended use | PreciControl Tumor Marker is used for quality control of Elecsys immunoassays on Elecsys immunoassay systems. |
| Predicate Device | We claim substantial equivalence to the currently marketed Elecsys® PreciControl Tumor Marker (K972235). |
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510(k) Summary - Elecsys® PreciControl Tumor Marker,
continued
The table below indicates the similarities between the modified Elecsys® Device Comparison PreciControl Tumor Marker and the current device.
| Topic | Elecsys® PreciControl TumorMarker(K972235) | Elecsys® PreciControl TumorMarker(Modified Device) |
|---|---|---|
| Intended Use | PreciControl Tumor Marker is usedfor quality control of Elecsysimmunoassays using the Elecsysimmunoassay systems (Elecsys 2010,1010 and others of the Elecsys familyof instruments). | PreciControl Tumor Marker is usedfor quality control of Elecsysimmunoassays on Elecsysimmunoassay systems. |
| AnalyzerSystem | Elecsys® immunoassay analyzers | Same |
| ReagentFormat | lyophilized, based on human serum | Same |
| AnalyteConcentrationPC TM1 / PCTM2 | AFP: approx. 8 & 100 IU/mlCEA: approx. 5 & 50 ng/mlCA 15-3 II: approx. 20 & 100 U/mLCA 125 II: approx. 35 & 100 U/mLFerritin: approx. 25 & 200 ng/mLfPSA: approx. 1 & 10 ng/mLtPSA: approx. 4 & 40 ng/mL | AFP: approx. 8 & 100 IU/mlCEA: approx. 5 & 50 ng/mlCA 15-3 II: approx. 20 & 100 U/mLCA 125 II: approx. 35 & 100 U/mLFerritin: approx. 25 & 200 ng/mLfPSA: approx. 1 & 10 ng/mLtPSA: approx. 4 & 40 ng/mLCA 19-9: approx. 20 & 100 U/mL, |
| Stability | @ 2-8° C• unopened until expiration date• opened for 2 weeks@ 20-25° C• on the analyzers, up to 5hours• 24 hours@ -20° C• 1 month (freeze only once)months at -20° C (only freeze once) | Same |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 tail feathers. The eagle is facing right and appears to be in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
APR 2 5 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Roche Diagnostics Corp. c/o Ms. Kay A. Taylor Regulatory Affairs Principal Centralized Diagnostics 9115 Hague Rd. Indianapolis, IN 46250
Re: K050387
Trade/Device Name: Elecsys PreciControl Tumor Marker Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: Class I Product Code: JJY Dated: February 14, 2005 Received: February 15, 2005
Dear Ms. Taylor:
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 prover to the ready 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advisour that 227 » ination 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 Part 801); good manufacturing practice requirements as set forth in the quality labeling (21 CFR Part 800), and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 – Ms Kay A. Taylor
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 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 Part 801), please contact the Office of Compliance at (240) 276-0131. 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/dsmamaif.html
Sincerely yours,
Lobert Becker/
Robert L. Becker, Jr., M.D., PhD 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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Indications for Use
510(k) Number (if known): Ko502
Device Name: Elecsys PreciControl Tumor Marker
Indications For Use:
PreciControl Tumor Marker is used for quality control of Elecsys immunoassays on Elecsys immunoassay systems.
The controls are used for monitoring the accuracy and precision of Elecsys immunoassays.
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)
In chan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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510(k) K050287
§ 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.