(58 days)
Not Found
No
The summary describes a calibrator solution for clinical chemistry analyzers, which is a chemical reagent, not a software or hardware device that would typically incorporate AI/ML. There are no mentions of AI, ML, or related concepts.
No
The device is a calibrator for laboratory instruments, used to ensure the accuracy of quantitative Roche methods on Roche clinical chemistry analyzers. It is not intended for the treatment, diagnosis, cure, mitigation, or prevention of disease.
No
The device is a calibrator for automated systems, used to calibrate Roche methods on clinical chemistry analyzers, not to diagnose medical conditions directly.
No
The device description explicitly states it consists of a buffered aqueous solution with biological materials, indicating it is a physical calibrator, not software.
Based on the provided information, 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 indicates it's used in vitro (outside the body) to calibrate instruments that measure substances in biological samples (urine/CSF).
- Device Description: It's a "buffered aqueous solution with biological materials added" used to obtain "desired component levels" for calibration. This aligns with the nature of a calibrator used in laboratory testing.
- Anatomical Site: While it mentions "Urine/CSF," this refers to the source of the samples being tested by the calibrated instruments, not the anatomical site where the device is used. The device itself is used in the laboratory.
- Predicate Device: The mention of a predicate device (K011226; Roche Diagnostic Calibrator for Automated Systems (C.f.a.s.) Proteins) further supports its classification as an IVD, as predicate devices are typically other legally marketed IVDs.
The lack of information about image processing, AI/ML, training/test sets, performance studies, and key metrics is expected for a calibrator, as its primary function is to provide known values for instrument calibration, not to perform diagnostic analysis itself.
N/A
Intended Use / Indications for Use
C.f.a.s. (Calibrator for automated systems) PUC (Proteins in Urine/CSF) is 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 Calibrator for Automated Systems Proteins in Urine/CSF (C.f.a.s. PUC) consists of a buffered aqueous solution 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
Not Found
Key Metrics
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
APR = 2 2004
510(k) Summary
According to the requirements of 21 CFR 807.92, the following information Introduction 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 - 3831
Contact Person: Sherri L Coenen
Date Prepared: February 3, 2004
Proprietary name: Calibrator for Automated Systems Proteins in Urine/CSF Device Name (C.f.a.s. PUC)
Common name: C.f.a.s. PUC
Classification name: Calibrator, Multi-analyte mixture
Device Description The Calibrator for Automated Systems Proteins in Urine/CSF (C.f.a.s. PUC) consists of a buffered aqueous solution with biological materials added as required to obtain desired component levels. Values for constituent analytes are provided in product labeling.
1
1
:
510(k) Summary, Continued
| Intended use | C.f.a.s. (Calibrator for automated systems) PUC (Proteins in Urine/CSF) is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet. |
|---|---|
| Substantial Equivalence | The Calibrator for Automated Systems Proteins in Urine/CSF (C.f.a.s. PUC) is substantially equivalent to other devices legally marketed in the United States. We claim equivalence to the Roche Diagnostic Calibrator for Automated Systems (C.f.a.s.) Proteins (K011226). The intended use of both devices is the establishment of calibration curves for their respective test systems. |
Substantial equivalence - similarities
The following table compares the Calibrator for Automated Systems Proteins in Urine/CSF (C.f.a.s. PUC) with the predicate device.
| Feature | C.f.a.s. PUC | C.f.a.s. Proteins (Predicate Device) |
|---|---|---|
| --------- | -------------- | -------------------------------------- |
| Feature | C.f.a.s. PUC | C.f.a.s. Proteins
(Predicate Device) |
|--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Cfas PUC is for use in the
calibration of quantitative
Roche methods on Roche
clinical chemistry analyzers
as specified in the enclosed
value sheet. | Cfas Proteins is for use in the
calibration of quantitative
Roche methods on Roche
clinical chemistry analyzers
as specified in the enclosed
value sheet. |
| Format | Liquid ready-for-use
calibrator based on a
buffered aqueous solution.
Concentrations of calibrator
components have been
adjusted to ensure optimal
calibration. | Liquid ready-for-use
calibrator based on stabilized
human serum. Concentrations
of calibrator components
have been adjusted to ensure
optimal calibration. |
| Stability | Unopened: Stable at 2-
8°C until expiration date. Opened: Stable for 4
weeks at 2-8°C. | Unopened: Stable at 2-
8°C until expiration date. Opened: Stable for 4
weeks at 2-8°C. |
| Levels | Single Level | Single Level |
...
.
.
2
510(k) Summary, Continued
Substantial equivalence – differences
Comparison of proposed Calibrator for Automated Systems Proteins in Urine/CSF (C.f.a.s. PUC) and predicate device.
| Feature | C.f.a.s. PUC | C.f.a.s. Proteins
(Predicate Device) |
|---------|---------------------------|-----------------------------------------|
| Matrix | Buffered aqueous solution | Stabilized human serum |
| Constituent Analytes | |
|---|---|
| C.f.a.s. PUC | C.f.a.s. Proteins |
| (Predicate Device) | |
| Albumin | α1-antitrypsin |
| Total Protein | Antistreptolysin O |
| Urine/ CSF Protein | C3c |
| C4 | |
| Ceruloplasmin | |
| C-Reactive Protein (Latex) | |
| Ferritin | |
| Haptoglobin | |
| IgA | |
| IgG | |
| IgM | |
| Prealbumin | |
| Transferrin |
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with its wings spread, and three wavy lines below it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
APR - 2 2004
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Sherri L. Coenen Regulatory Affairs Associate Regulatory Submissions Roche Diagnostics Corp. 9115 Hague Rd. Indianapolis, IN 46250
K040264 Re:
Trade/Device Name: Calibrator for Automated Systems Proteins in Urine/ CSF (C.f.a.s. PUC) Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: February 3, 2004 Received: February 4, 2004
Dear Ms. Coenen:
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 docs 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,
Jean M. Cooper, MS, DVM.
Jean 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
510(k) Number (if known):___K040264
Device Name: Calibrator for Automated Systems Proteins in Urine/CSF (C.f.a.s. PUC)
Indications For Use:
C.f.a.s. (Calibrator for automated systems) PUC (Proteins in Urine/CSF) is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet.
Prescription Use × (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)
Alberto GuM
Division Sign
Office of In Vitro Diagnostic Device Evaluation and Safety
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