(169 days)
Prealbumin/Ceruloplasmin Control Set (Precinorm/Precipath PC) is used for quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.
Proprietary name: Prealbumin/Ceruloplasmin Control Set
Common name: Precinorm/Precipath PC
Classification name: Multi-Analyte Controls, All Kinds (assayed and unassayed) in Class I
Matrix: Human serum with material of biological origin as specified
Format: Lyophilized
Handling: Reconstitute with exactly 1.0 mL of distilled water and allow to stand closed for 30 minutes to reconstitute, and then mix gently.
This submission describes the Prealbumin/Ceruloplasmin Control Set (Precinorm/Precipath PC), a Class I device used for quality control by monitoring the accuracy and precision of quantitative methods for Prealbumin and Ceruloplasmin. The submission focuses on demonstrating substantial equivalence to a predicate device, Precinorm PUC (K040280), rather than providing detailed acceptance criteria and a standalone study for the device's performance.
Here's the breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided submission does not specify quantitative acceptance criteria or provide detailed performance data for the Prealbumin/Ceruloplasmin Control Set. Instead, it states that "The Prealbumin/Ceruloplasmin Control Set was evaluated for value assignment and stability. A summary of the evaluation studies is provided in the Performance Characteristics Section of this submission." However, the "Performance Characteristics Section" itself is not included in the provided document.
The document focuses on comparing the new device to a predicate device, noting similarities in intended use and stability, and differences in matrix, format, and handling.
| Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Intended Use | To be used for quality control by monitoring accuracy and precision for quantitative methods as specified in the enclosed value sheet. | Prealbumin/Ceruloplasmin Control Set (Precinorm/Precipath PC) is used for quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet. (Matches intended use of predicate) |
| Stability | Unopened: Store at 2-8°C until expiration date. Reconstituted: * At 15 – 25 °C: up to 8 hrs * At 2-8°C: 2 days * At (-15)-(-25)°C: 2 weeks (freeze only once) | Matches the described stability, which is comparable but not identical to the predicate (Opened: Stable for 4 weeks at 2-8°C for predicate). The exact performance to meet these criteria is not detailed. |
| Value Assignment | Not specified. | "Evaluated for value assignment" (Details not provided). |
| Accuracy & Precision | Not specified. | "monitoring accuracy and precision" (Performance metrics not provided). |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the given document. The submission mentions "evaluations summary" and "performance characteristics," but no details on sample size, data country of origin, or whether the study was retrospective or prospective are included.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable and not provided. This device is a quality control material for laboratory assays, not an imaging or diagnostic device that requires expert interpretation for establishing ground truth on patient data. Ground truth for control materials typically relates to the assigned values of the analytes within the control, which are established through rigorous analytical methods, often by the manufacturer.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. As explained above, this device does not involve a diagnostic decision or interpretation of patient data that would require an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not applicable and not provided. This device is a quality control material, not an AI-powered diagnostic device, and therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to its purpose.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable and not provided. This device is a laboratory control material, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for this type of device (quality control material) would primarily be the assigned values of the analytes (Prealbumin and Ceruloplasmin) within the control material. These values are established through the manufacturer's value assignment process, which typically involves multiple measurements using reference methods and/or calibrated instruments. The document states the device "was evaluated for value assignment," implying this process was conducted, but specific details are not provided.
8. The Sample Size for the Training Set
This information is not applicable and not provided. This device is a quality control material, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided. (See point 8).
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JAN 3 1 2007
510(k) Summary
| Purpose | In accordance with 21 CFR 907.87, Roche Diagnostics hereby submitsofficial notification as required by Section 510(k) of the Federal Food, Drugand Cosmetics Act of our intention to market the device described in thisPremarket Notification [510(k)]. | |||
|---|---|---|---|---|
| Device Name | Proprietary name: Prealbumin/Ceruloplasmin Control SetCommon name: Precinorm/Precipath PCClassification name: Multi-Analyte Controls, All Kinds (assayed andunassayed) in Class I | |||
| Establishment registration | The establishment registration number for Roche Diagnostics Penzberg is9610529. | |||
| Classification | The FDA has classified Multi-Analyte Controls, All Kinds (assayed andunassayed) in Class I. | |||
| Panel | Classification Number | Classification Name | Regulation Citation | |
| 75 ClinicalChemistry | JJY | Quality control material(assayed and unassayed) | 21 CFR 862.1660 |
: 上一篇:
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| PerformanceStandards | To date, no performance standards that affect this device have been finalizedunder Section 514 of the Act. |
|---|---|
| Proposedlabeling | Proposed labeling sufficient to describe the device, its intended use, and thedirections for use are attached. We believe the proposed version of the devicelabeling presented in Section V contains all of the technical informationrequired per 21 CFR 809.10. |
| Substantialequivalence | Prealbumin/Ceruloplasmin Control Set is substantially equivalent to otherproducts in commercial distribution intended for similar use. We claimequivalency to the currently marketed Precinorm PUC (K040280). |
| Substantialequivalence:Similarities | The below tables compare Prealbumin/Ceruloplasmin Control Set with thepredicate device, Precinorm PUC (K040280). |
| Characteristic | Prealbumin/CeruloplasminControl Set | Predicate DevicePrecinorm PUC (K040280). |
|---|---|---|
| Intended Use | Prealbumin/CeruloplasminControl Set(Precinorm/Precipath PC) isused for quality control bymonitoring accuracy andprecision for the quantitativemethods as specified in theenclosed value sheet. | Precinorm PUC (Proteins inUrine/CSF) is for use inquality control by monitoringaccuracy and precision for thequantitative methods asspecified in the enclosed valuesheet. |
| Stability | Unopened:• Store at 2-8°C untilexpiration dateReconstituted:• at 15 – 25 °C: up to 8 hrs• at 2-8°C: 2 days• at (-15)-(-25)°C: 2 weeks(freeze only once) | Unopened:• Store at 2-8°C untilexpiration dateOpened:• Stable for 4 weeks at 2-8°C. |
Continued on next page
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Differences
.
| Characteristic | Prealbumin/CeruloplasminControl Set | Predicate DevicePrecinorm PUC (K040280). |
|---|---|---|
| Matrix | Human serum with materialof biological origin asspecified | Buffered aqueous solution |
| Format | Lyophilized | Liquid ready-for-use controlbased on a buffered aqueoussolution. |
| Handling | Reconstitute with exactly 1.0mL of distilled water andallow to stand closed for 30minutes to reconstitute, andthen mix gently. | Liquid ready-for-use controlbased on a buffered aqueoussolution. Concentrations ofcontrol components have beenadjusted to represent normalranges. |
| Evaluations summary | The Prealbumin/Ceruloplasmin Control Set was evaluated for value assignment and stability. A summary of the evaluation studies is provided in the Performance Characteristics Section of this submission. |
|---|---|
| Confidentiality | Roche Diagnostics Corporation requests that the FDA not disclose the nature or existence of the premarket notification until the substantial equivalence decision has been reached. |
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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 graphic of three curved lines that resemble a human figure, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the graphic. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Roche Diagnostics Corporation. c/o Ms. Corina Harper Regulatory Affairs Consultant 9115 Hague Road Indianapolis, IN 46250
JAN 3 1 2007
Re: K062379
Trade/Device Name: Prealbumin/Ceruloplasmin Control Set Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: January 10, 2007 Received: January 11, 2007
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 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 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 Part 801); 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
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Page 2 --
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) 276-0450. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Robert Becker J.
Robert L. Becker, Jr., M.D. 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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Indications for Use
510(k) Number (if known): KD62379
COBAS INTEGRA Ceruloplasmin: Ceruloplasmin
Indications For Use:
Prealbumin/Ceruloplasmin Control Set (Precinorm/Precipath PC) is used for quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.
Prescription Use XXX
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
Maria M Chan
Division Sign-Off
Page 1 of
Office of In Vitro D Device Evatuation a
Kob 2379
§ 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.