(50 days)
The C.f.a.s. PAC is intended for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet.
The C.f.a.s. PAC is a lyophilized product consisting of human serum with biological materials added as required to obtain desired component levels. Values for constituent analytes are provided in product labeling.
The provided document is a 510(k) summary for a medical device called "C.f.a.s. PAC," which is a calibrator for automated systems. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed study information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or expert involvement that you requested.
The document states under "Performance Characteristics":
- "The C.f.a.s. PAC was evaluated for value assignment and stability."
This phrase indicates that a study was performed, but the results, methodology, acceptance criteria, and other specifics of that study are not included in this summary. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than providing a performance study report.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The requested information (Table of acceptance criteria and reported performance, sample sizes, data provenance, number and qualifications of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size, and training ground truth establishment) is not present in this document.
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mar 2 4 2004
.
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 RoadIndianapolis, IN 46250317-521-3723 |
| Contact Person: Theresa M. Ambrose | |
| Date Prepared: February 2, 2004 | |
| Device Name | Proprietary name: Calibrator for Automated Systems Prealbumin-ASLO-Ceruloplasmin (C.f.a.s. PAC ) |
| Common name: C.f.a.s. PAC | |
| Classification name: Calibrator, Multi-analyte mixture | |
| Predicatedevice | The C.f.a.s. PAC is substantially equivalent to the currently marketed C.f.a.s.Lipids (K011658). |
| DeviceDescription | The C.f.a.s. PAC is a lyophilized product consisting of human serum withbiological materials added as required to obtain desired component levels.Values for constituent analytes are provided in product labeling. |
| Intended use | The C.f.a.s. PAC is intended for use in the calibration of quantitative Rochemethods on Roche clinical chemistry analyzers as specified in the enclosedvalue sheet. |
| Continued on next page | |
| Comparison to | The C.f.a.s. PAC is substantially equivalent to the currently marketed C.f.a.s. |
| predicatedevice | Lipids (K011658). The below tables compare C.f.a.s. PAC with the predicatedevice, C.f.a.s. Lipids (K011658). |
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510(k) Summary, Continued
Similarities
| Characteristic | C.f.a.s. PAC | Predicate deviceC.f.a.s. Lipids (K011658) |
|---|---|---|
| Intended Use | C.f.a.s. PAC is intendedfor use in the calibrationof quantitative Rochemethods on Rocheclinical chemistryanalyzers as specified inthe enclosed value sheet. | C.f.a.s. Lipids is intendedfor use in the calibration ofquantitative Rochemethods on Roche clinicalchemistry analyzers asspecified in the enclosedvalue sheet. |
| Format | Lyophilized | same |
| Matrix | Human serum | same |
| Handling | Reconstitute with exactly1.0 mL distilled/deionized water.Carefully close the bottleand dissolve the contentscompletely by occasionalgentle swirling within 30minutes. | same |
| Levels | Single level | same |
Continued on next page
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510(k) Summary, Continued
:
Differences
:
| Characteristic | C.f.a.s. PAC | Predicate deviceC.f.a.s. Lipids (K011658) |
|---|---|---|
| Analytes | • Prealbumin• Antistreptolysin O(ASLO)• Ceruloplasmin | • Apolipoprotein Al• Apolipoprotein B• HDL-cholesterol• LDL-cholesterol |
| Stability | Unopened: stable up tothe stated expiration dateReconstituted:• 15 to 25 °C:8 hours• 2 to 8 °C:2 days• -15 to -25 °C: 2 weeks(when frozen once) | Unopened: stable up to thestated expiration dateReconstituted:• 15 to 25 °C:8 hours• 2 to 8 °C5 days• -15 to -25 °C4 weeks(when frozen once) |
and the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of
Performance Characteristics
· The C.f.a.s. PAC was evaluated for value assignment and stability.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Public Health Service
MAR 2 4 2004
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Theresa M. Ambrose, Ph.D. DABCC, FACB, RAC Regulatory Principal Centralized Diagnostics Regulatory Submissions Roche Diagnostics Corp. 9115 Hague Rd. Indianapolis, IN 46250
Re: K040245
Trade/Device Name: C.f.a.s. PAC Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: February 2, 2004 Received: February 03, 2004
Dear Dr. Ambrose :
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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2
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 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 (301) 594-3084. 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/dsmamain.html.
Sincerely yours.
Seain M. Cooper, US, DVM.
Yean M. Cooper, MS, D.V.M. 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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Indications for Use Statement
510(k) Number (if known): N/A
Device Name: C.f.a.s. PAC
Indications For Use: The C.f.a.s. PAC is intended for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet.
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use _____________
(Optional Format 1-2-96)
Carol Benson
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K040245
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.