C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C

K052101 · Roche Diagnostics · KRZ · Aug 26, 2005 · Hematology

Device Facts

• Record ID: K052101
• Device Name: C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C
• Applicant: Roche Diagnostics
• Product Code: KRZ · Hematology
• Decision Date: Aug 26, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 864.8165
• Device Class: Class 2

Intended Use

The Roche Diagnostics C.f.a.s. (Calibrator for automated systems) HbA1c is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet. For Prescription use only.

Device Story

C.f.a.s. HbA1c is a single-level lyophilized calibrator composed of hemolyzed sheep and human blood; used to calibrate quantitative Roche HbA1c methods on Roche clinical chemistry analyzers. The product is reconstituted with 2.0 mL of distilled or deionized water by laboratory personnel. Once loaded onto the analyzer, the system automatically performs dilutions to generate six calibration levels. The resulting calibration curve allows the analyzer to accurately quantify HbA1c levels in patient samples. This process ensures the accuracy of clinical chemistry measurements, supporting healthcare providers in the diagnosis and monitoring of glycemic control in patients.

Clinical Evidence

No clinical data. Evidence consists of analytical performance and stability testing. Traceability established to CRM 522 (Hb) and IFCC reference method (HbA1c) via multi-laboratory value assignment. Real-time shelf-life stability (up to 30 months) and accelerated stability (5 days at 35°C) confirmed recovery within ±10% of assigned values. Reconstituted stability confirmed for 8 hours at 30°C, 2 days at 4°C, and 3 months at -20°C.

Technological Characteristics

Lyophilized calibrator; matrix: hemolyzed sheep blood with human blood additives and 0.9% TTAB. Reconstituted with distilled/deionized water. Traceable to CRM 522 and IFCC reference materials. Barcode-encoded for automated analyzer calibration. Stability: 30 months shelf-life at 2-8°C.

Indications for Use

Indicated for use as a calibrator for quantitative Roche HbA1c methods on Roche clinical chemistry analyzers (specifically Cobas Integra 800).

Regulatory Classification

Identification

A calibrator for hemoglobin or hematocrit measurement is a device that approximates whole blood, red blood cells, or a hemoglobin derivative and that is used to set instruments intended to measure hemoglobin, the hematocrit, or both. It is a material whose characteristics have been precisely and accurately determined.

Special Controls

*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 § 864.9.

Predicate Devices

• Tina-Quant HbA1c reagent kit calibrator (K934070)

Submission Summary (Full Text)

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## 510(k) Summary – C.f.a.s. (Calibrator for Automated Systems) HbA1c

| 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<br>9115 Hague Rd<br>Indianapolis IN 46250<br>[phone] |
| | Contact person: Theresa M. Ambrose |
| | Date prepared: August 2, 2005 |
| Device name | Proprietary name: C.f.a.s. (Calibrator for Automated Systems) HbA1c |
| | Common name: calibrator for Hemoglobin measurements |
| | Classification name: Calibrator for hemoglobin or hematocrit measurement |
| Device description | C.f.a.s. HbA1c is single-level lyophilized calibrator based on hemolyzed sheep blood and human blood. The concentrations of the calibrator components have been adjusted to ensure optimal calibration of the appropriate Roche methods on clinical chemistry analyzers. During use, calibrator dilutions are prepared automatically on-board the analyzer resulting in six levels. |
| Intended use | C.f.a.s. (Calibrator for automated systems) HbA1c is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet. |
| Predicate device | We claim substantial equivalence to the calibrator included in the Tina-Quant HbA1c reagent kit, originally cleared under K934070. |
| | C.f.a.s. HbA1c is identical to this calibrator; however, it is now being provided at a single-level and sold as a separate product. |

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## 510(k) Summary – C.f.a.s. (Calibrator for Automated Systems) HbA1c, Continued

The table below indicates the similarities between the modified C.f.a.s. Substantial (Calibrator for Automated Systems) HbA1c and its predicate device equivalency -(calibrator in Tina-Quant HbA1c test system, K934070). similiarities

| Characteristic | Predicate calibrator | C.f.a.s. HbA1c |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Calibrator included in kit<br>for calibration of the<br>quantitative Tina-Quant<br>HbA1c method. | C.f.a.s. (Calibrator for<br>automated systems) HbA1c is<br>for use in the calibration of<br>quantitative Roche methods<br>on Roche clinical chemistry<br>analyzers as specified in the<br>enclosed value sheet. |
| Format | Lyophilized | Same |
| Matrix and composition | Hemolysate derived from<br>human and sheep blood;<br>0.9% TTAB<br>(tetradecyltrimethylamm<br>onium bromide);<br>stabilizers | Same |

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## 510(k) Summary – C.f.a.s. (Calibrator for Automated Systems) HbA1c, Continued

The table below indicates the differences between the modified C.f.a.s. Substantial (Calibrator for Automated Systems) HbA1c and its predicate device equivalency -(calibrator in Tina-Quant HbA1c test system, K934070). differences

| Characteristic | Predicate calibrator | C.f.a.s. HbA1c |
|----------------|------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Handling | Reconstitute with 1.0 mL distilled or deionized water. | Reconstitute with 2.0 mL distilled or deionized water. |
| Levels | Four levels | Single level |
| Stability | Unopened: stable up to the expiration date | Unopened: same |
| | Reconstituted:<br>2 days @ 2-8 °C<br>8 hours @ 20-25 °C<br>3 months @ -20 °C | Reconstituted:<br>2 days @ 2-8 °C<br>8 hours @ 15-25 °C<br>3 months @ (-15) to (-25) °C |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.

Public Health Service

AUG 26 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Theresa M. Ambrose. Ph.D., RAC Regulatory Principal Roche Diagnostics Centralized Diagnostics 9115 Hague Road Indianapolis, IN 46250

Re: k052101

> Trade/Device Name: C.f.a.s. (Calibrator for Automated Systems) HbA1c Regulation Number: 21 CFR 864.8165 Regulation Name: Calibrator for hemoglobin or hematocrit measurement Regulatory Class: Class II Product Code: KRZ Dated: August 2, 2005 Received: August 3, 2005

Dear Ms. 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. Iisting 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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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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Carol C. Benam

Carol C. Benson, M.A. Acting 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):

KOS201

Device Name: C.f.a.s. (Calibrator for Automated Systems) HbA1c

Indications For Use:

C.f.a.s. (Calibrator for automated systems) HbA Ic is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet.

Prescription Use XXX (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)

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