(35 days)
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 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.
This 510(k) submission describes modifications to an existing calibrator device, the Calibrator for Automated Systems (C.f.a.s.). It focuses on demonstrating substantial equivalence to the predicate device (K033501) rather than a comprehensive de novo study with acceptance criteria and a detailed study report comparing the device's performance against those criteria. Therefore, much of the requested information regarding an acceptance criteria study in the typical sense (e.g., sample size, ground truth, expert opinions, MRMC studies, standalone performance) is not directly present.
However, based on the provided text, we can infer some "acceptance criteria" through the modifications and the declaration of conformity to design controls, and describe the "study" as the validation activities conducted under design control.
Here's an attempt to address your request based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a modification submission, the "acceptance criteria" are implied by demonstrating that the modified device's performance, particularly its stability and traceability, remains appropriate for its intended use and is substantially equivalent to the predicate. The "reported device performance" is the successful outcome of the validation and development activities.
| Acceptance Criteria (Implied) | Reported Device Performance (as per submission) |
|---|---|
| Intended Use/Indications for Use: Remain unchanged from predicate. | Same as predicate. (Paragraph 1, Table: Similarities/Differences) |
| Reagent Composition: Changes (addition of pyridoxal phosphate) do not negatively impact performance or intended use. | Pyridoxal-phosphate addition acknowledged. (Paragraph 1, Table: Similarities/Differences). Overall, the modification "does not alter the fundamental scientific technology of the device." (Paragraph 3, Closing). The implication is that the performance is maintained. |
| Stability (Reconstituted): New stability claim (4 weeks frozen) for reconstituted product is supported. | Reconstituted stability claimed: 4 weeks (frozen once) at (-15) to (-25)° C (increased from 2 weeks for predicate). (Paragraph 1, Table: Similarities/Differences). The "overall product specifications were met" through Validation and Development activities under design control. (Paragraph 2, Validation and Development activities). |
| Traceability: Modifications to traceability for specific analytes maintain accuracy and consistency. | Traceability changed for specific analytes: Direct Bilirubin, Calcium, Creatinine, Iron, Magnesium, UIBC, Uric Acid. (Paragraph 2, Table: Similarities/Differences). The "overall product specifications were met" through Validation and Development activities under design control, implying the new traceability methods are adequate. |
| Value Assignment Procedure: Modified procedure ensures accurate and consistent value assignment for new lots. | Modified value assignment procedure: Values to new lots assigned by running as samples after calibrating with previously assigned C.f.a.s. lot, then verified using reference material, Master lot C.f.a.s., and previously assigned lots. This is a change from the predicate's method of calibrating with the Master Lot. (Paragraph 2, Table: Similarities/Differences). The "overall product specifications were met" through Validation and Development activities under design control, indicating this new procedure is acceptable. |
| Overall Product Specifications: All product specifications are met following modifications. | Overall product specifications were met. (Paragraph 2, Validation and Development activities) |
| Conformity to Design Controls and Risk Analysis: Deviations from the predicate are managed according to design control. | Declaration of Conformity with Design Controls and Results of Risk Analysis are provided. (Paragraph 2, Validation and Development activities) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of a clinical or analytical study with a distinct sample size for this 510(k) modification. The validation and development activities would have involved various measurements and comparisons, but specific sample sizes for these internal studies are not detailed.
- Data Provenance: The studies were conducted internally by Roche Diagnostics Corporation, likely at their Indianapolis, IN (USA) facility. The nature of the data would be laboratory-generated analytical data from the calibrator. The studies are prospective in the sense that they were conducted for this device modification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of information is generally not applicable to the analytical performance testing of a calibrator. "Ground truth" for a calibrator is established through highly controlled, traceable analytical methods and reference materials, not typically through a panel of human experts. The data supporting the performance reflects the analytical measurements themselves.
4. Adjudication Method for the Test Set
Not applicable, as human expert adjudication is not relevant for establishing the performance of an analytical calibrator.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
Not applicable. This device is an analytical calibrator, not an imaging device or diagnostic tool that requires human interpretation. Therefore, MRMC studies are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable to a chemical calibrator. The calibrator itself is a "standalone" product that performs its function (calibration) without human "interpretation" of its result in the way an algorithm might. Its performance is measured analytically.
7. The Type of Ground Truth Used
The ground truth for a calibrator’s performance (e.g., the accuracy of its assigned values and its stability) is established through:
- Reference materials: Highly characterized substances with known, accurate concentrations or properties.
- Reference methods: Established, validated analytical procedures known to provide accurate results.
- Traceability: The ability to link the measurements to national or international standards.
The document explicitly states "Traceability through standards or reference methods analyzed at all set point validation runs" and "Values are verified by using reference material, Master lot C.f.a.s. and previously assigned lots of C.f.a.s." (Paragraph 2, Table: Similarities/Differences).
8. The Sample Size for the Training Set
Not applicable. This device is a calibrator, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set."
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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 forUse | Calibrator for Automated Systems(C.f.a.s.) is for use in the calibrationof quantitative Roche methods onRoche clinical chemistry analyzersas specified in the lot specific valuesheet. | Same |
| Reagentcomposition | Lyophilized human serum withchemical additives and material ofbiological origin | SamePyridoxal-phosphate addition |
| Stability - shelflife and on-board | 2-8 °C until expiration dateReconstituted:8 hours at 15 to 25° C2 days at 2 to 8° C8 hours at 15 to 25° C2 weeks (frozen once) at (-15) to (-25)° C | SameReconstituted:8 hours at 15 to 25° C2 days at 2 to 8° C8 hours at 15 to 25° C4 weeks (frozen once) at (-15) to (-25)° C |
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| Traceability | Traceability through Master Lot(ML) to standards or referencemethods. | Traceability through standards orreference methods analyzed at allset point validation runs. |
|---|---|---|
| Traceability changed for thefollowing analytes:Direct BilirubinCalciumCreatinine, Jaffe/RB/CompensatedIron | ||
| Magnesium, Xylidyl Blue/ChlorophosphonazoUIBCUric Acid | ||
| ValueAssignment | Values to new lots are assigned byrunning them as samples aftercalibrating the system with theMaster Lot of C.f.a.s. | Values to new lots are assigned byrunning them as samples aftercalibrating the system withpreviously assigned C.f.a.s lot.Values are verified by usingreference material, Master lotC.f.a.s. and previously assigned lotsof 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
§ 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.