(50 days)
Not Found
No
The summary describes a calibration standard for clinical chemistry analyzers, which is a physical product, not a software or algorithm-based device. There is no mention of AI, ML, or any computational processing of data that would suggest the use of these technologies.
No
Explanation: The device is a calibrator for quantitative Roche methods and is used in clinical chemistry analyzers, not for treating any medical condition.
No
The device is a calibrator for quantitative Roche methods, not a diagnostic device itself. Its purpose is to ensure the accuracy of other diagnostic instruments.
No
The device description clearly states it is a "lyophilized product consisting of human serum with biological materials added," indicating it is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "calibration of quantitative Roche methods on Roche clinical chemistry analyzers." This means it's used in vitro (outside the body) to calibrate instruments that measure substances in biological samples (like serum).
- Device Description: It's a "lyophilized product consisting of human serum with biological materials added." This is a common format for calibrators used in clinical chemistry, which is a branch of IVD testing.
- Performance Studies: The mention of "value assignment and stability" evaluation is typical for IVD calibrators, as their accuracy and reliability are crucial for accurate test results.
- Predicate Device: The predicate device, "C.f.a.s. Lipids," is also a calibrator used in clinical chemistry, further supporting the IVD nature of this device.
The lack of information about image processing, AI/ML, anatomical site, patient age, user, and training/test sets is consistent with a calibrator, which is a reagent used to ensure the accuracy of the analytical instrument, not a device that directly analyzes patient samples or uses complex algorithms.
N/A
Intended Use / 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.
Product codes
JIX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The C.f.a.s. PAC was evaluated for value assignment and stability.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
mar 2 4 2004
.
510(k) Summary
| 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
9115 Hague Road
Indianapolis, IN 46250
317-521-3723 |
| | 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 |
| Predicate
device | The C.f.a.s. PAC is substantially equivalent to the currently marketed C.f.a.s.
Lipids (K011658). |
| Device
Description | 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. |
| Intended 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. |
| | Continued on next page |
| Comparison to | The C.f.a.s. PAC is substantially equivalent to the currently marketed C.f.a.s. |
| predicate
device | Lipids (K011658). The below tables compare C.f.a.s. PAC with the predicate
device, C.f.a.s. Lipids (K011658). |
1
510(k) Summary, Continued
Similarities
| Characteristic | C.f.a.s. PAC | Predicate device
C.f.a.s. Lipids (K011658) |
|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | 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. | C.f.a.s. Lipids is intended
for use in the calibration of
quantitative Roche
methods on Roche clinical
chemistry analyzers as
specified in the enclosed
value sheet. |
| Format | Lyophilized | same |
| Matrix | Human serum | same |
| Handling | Reconstitute with exactly
1.0 mL distilled/
deionized water.
Carefully close the bottle
and dissolve the contents
completely by occasional
gentle swirling within 30
minutes. | same |
| Levels | Single level | same |
Continued on next page
2
510(k) Summary, Continued
:
Differences
:
| Characteristic | C.f.a.s. PAC | Predicate device
C.f.a.s. Lipids (K011658) |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Analytes | • Prealbumin
• Antistreptolysin O
(ASLO)
• Ceruloplasmin | • Apolipoprotein Al
• Apolipoprotein B
• HDL-cholesterol
• LDL-cholesterol |
| Stability | Unopened: stable up to
the stated expiration date
Reconstituted:
• 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 the
stated expiration date
Reconstituted:
• 15 to 25 °C:
8 hours
• 2 to 8 °C
5 days
• -15 to -25 °C
4 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.
3
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).
4
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
5
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