(35 days)
Not Found
No
The document describes a calibrator for chemistry analyzers, which is a physical substance used for calibration, not a software or system that would typically incorporate AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
The device is a calibrator for quantitative methods on chemistry analyzers, which is used for diagnostic purposes, not therapeutic intervention.
No
This device is a calibrator, used to calibrate diagnostic systems, rather than performing diagnosis itself.
No
The device description explicitly states it is a "lyophilized calibrator based on human serum," which 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 chemistry analyzers." This indicates it's used in a laboratory setting to ensure the accuracy of tests performed on patient samples.
- Device Description: The description confirms it's a "lyophilized calibrator based on human serum." Calibrators are essential components in many in vitro diagnostic tests to establish a known reference point for measurement.
- Predicate Device: The mention of a predicate device (K033501; Calibrator for Automated Systems (C.f.a.s.)) which is also a calibrator, further supports its classification as an IVD. Predicate devices are legally marketed devices that are substantially equivalent to the new device, and in the context of medical devices, this often points to a similar regulatory classification.
Based on the provided information, the device fits the definition of an in vitro diagnostic device, which is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of disease or other conditions.
N/A
Intended Use / Indications for Use
Calibrator for Automated Systems (C.f.a.s.) is for use in the calibration of quantitative Roche methods on Roche chemistry analyzers as specified in the enclosed value sheet.
Product codes
JIX
Device Description
Calibrator for Automated Systems (C.f.a.s.) is for use in the calibration of quantitative Roche methods on Roche chemistry analyzers as specified in the enclosed value sheet. Calibrator for Automated Systems (C.f.a.s.) is a lyophilized calibrator based on human serum.
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)
Not Found
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.
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SEP 1 3 2006
510(k) Summary - Calibrator for Automated Systems (C.f.a.s)
Introduction Roche Diagnostics Corporation hereby submits this Special 510(k): Device Modification to provide notification of modifications to our Calibrator for Automated Systems (C.f.a.s.). This calibrator was originally cleared for use as K990460 and modified via K033501. Modifications to the calibrator include: Modification to reagent composition: addition of pyridoxal phosphate . Change of stability claim after reconstitution . Modifications to value assignment procedure: including use of internal ● laboratory . Changes to traceability for select analytes Roche Diagnostics Submitter name, address, 9115 Hague Rd contact Indianapolis IN 46250 (317) 521-3723 Contact person: Corina Harper Date prepared: May 12, 2006 Device Name Proprietary name: Calibrator for Automated Systems (C.f.a.s.) Common name: Calibrator for Automated Systems (C.f.a.s.) Classification name: Calibrator, Multi-analyte mixture Device Calibrator for Automated Systems (C.f.a.s.) is for use in the calibration of Description quantitative Roche methods on Roche chemistry analyzers as specified in the enclosed value sheet. Calibrator for Automated Systems (C.f.a.s.) is a lyophilized calibrator based on human serum. Intended use Calibrator for Automated Systems (C.f.a.s.) is for use in the calibration of quantitative Roche methods on Roche chemistry analyzers as specified in the enclosed value sheet.
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| Predicate | We claim substantial equivalence to the Calibrator for Automated Systems |
|---|---|
| Device | (C.f.a.s.) cleared as K033501. |
Substantial The table below indicates the similarities and differences between the equivalency modified Calibrator for Automated Systems (C.f.a.s.) and its predicate device Similarities/Diff (Calibrator for Automated Systems (C.f.a.s.), K033501). erences
| Feature | Predicate device: C.f.a.s.
(K033501) | Modified device: C.f.a.s. |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/
Indications for
Use | Calibrator for Automated Systems
(C.f.a.s.) is for use in the calibration
of quantitative Roche methods on
Roche clinical chemistry analyzers
as specified in the lot specific value
sheet. | Same |
| Reagent
composition | Lyophilized human serum with
chemical additives and material of
biological origin | Same
Pyridoxal-phosphate addition |
| Stability - shelf
life and on-board | 2-8 °C until expiration date
Reconstituted:
8 hours at 15 to 25° C
2 days at 2 to 8° C
8 hours at 15 to 25° C
2 weeks (frozen once) at (-15) to (-
25)° C | Same
Reconstituted:
8 hours at 15 to 25° C
2 days at 2 to 8° C
8 hours at 15 to 25° C
4 weeks (frozen once) at (-15) to (-
25)° C |
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| Traceability | Traceability through Master Lot
(ML) to standards or reference
methods. | Traceability through standards or
reference methods analyzed at all
set point validation runs. |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Traceability changed for the
following analytes:
Direct Bilirubin
Calcium
Creatinine, Jaffe/RB/Compensated
Iron |
| | | Magnesium, Xylidyl Blue
/Chlorophosphonazo
UIBC
Uric Acid |
| Value
Assignment | Values to new lots are assigned by
running them as samples after
calibrating the system with the
Master Lot of C.f.a.s. | Values to new lots are assigned by
running them as samples after
calibrating the system with
previously assigned C.f.a.s lot.
Values are verified by using
reference material, Master lot
C.f.a.s. and previously assigned lots
of C.f.a.s. |
Proposed Proposed labeling sufficient to describe the device, its intended use, and the Labeling directions for use can be found in Section V. We believe the proposed version of the device labeling presented contains all of the technical information required per 21 CFR 809.10. のアイデントです。 Validation and Development activities were conducted under appropriate design control Design Control procedures and the overall product specifications were met. The Declaration of Conformity with Design Controls and Results of Risk Analysis are provided in Section 5.1. Analytical Performance.
Confidentiality Roche Diagnostics Corporation requests that the FDA not disclose the nature or existence of this submission until the substantial equivalence decision has been reached.
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Modification of the Calibrator for Automated Systems (C.f.a.s.) does not Closing affect the intended use or indications for use of the device as described in the labeling, nor does it alter the fundamental scientific technology of the device. Therefore, we trust the information provided in this Special 510(k) will support a decision of substantial equivalence of the Calibrator for Automated Systems (C.f.a.s.) to the predicate.
If you have any questions or require further information, please do not hesitate to contact this office.
- · Phone: (317) 521-3831
- · FAX: (317) 521-2324
- · email: corina.harper@roche.com
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/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 stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 1 3 2006
Ms. Corina Harper Roche Diagnostics Corporation 9115 Hague Road Indianapolis, IN 46250-0457
Re: K062319
Trade/Device Name: Calibrator for Automated System C.f.s.a. Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: August 8, 2006 Received: August 9, 2006
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 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 (240) 276-0484. 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/industry/support/index.html.
Sincerely yours,
Alberto Garcia
Alberto Gutierrez, Ph.D. 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
510(k) Number (if known): K062319
Calibrator for automated systems: C.f.a.s.
Indications For Use:
Calibrator for automated systems (C.f.a.s.) is for use in the calibration of quantitative Canorator for advinated bytwiss (chemistry analyzers 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)
Page 1 of
Carol Benson
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety