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

K990460 · Roche Diagnostics Corp. · JIX · Mar 22, 1999 · Clinical Chemistry

Device Facts

• Record ID: K990460
• Device Name: CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.)
• Applicant: Roche Diagnostics Corp.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Mar 22, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The Calibrator for Automated Systems (C.f.a.s.) is intended for use as a calibrator of clinical chemistry assays. The material is well suited for automated analytical procedures.

Device Story

Calibrator for Automated Systems (C.f.a.s.) is a lyophilized human serum-based product containing various biological constituents; used to establish reference points for clinical chemistry assays. Device is intended for use in clinical laboratory settings by trained personnel to calibrate automated analytical systems. By providing known analyte levels, the calibrator allows the clinical chemistry analyzer to adjust its measurement parameters, ensuring accurate quantification of patient samples. This process supports healthcare providers in obtaining reliable diagnostic data for clinical decision-making.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Lyophilized pooled human serum; multi-analyte mixture. Stable at 2-8 °C until expiration; stable 2 days when reconstituted and stored at 2-8 °C. Designed for use with automated clinical chemistry analyzers.

Indications for Use

Indicated for use as a calibrator of clinical chemistry assays in automated analytical procedures. For prescription use only.

Regulatory Classification

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.)

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 § 862.9.

Predicate Devices

• Roche Serum Calibrator

Submission Summary (Full Text)

{0}------------------------------------------------

3/22/99

r

## 510(k) Summary

K990460

| 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 Corporation 9115 Hague Rd Indianapolis, IN 46250 [phone]<br><br>Contact person: Priscilla A. Hamill<br><br>Date prepared: February 10, 1999 |
| Device name | Proprietary name: Calibrator for Automated Systems (C.f.a.s.)<br><br>Common name: C.f.a.s.<br><br>Classification name: Calibrator, Multi-analyte mixture |
| Predicate device | We claim substantial equivalence to Roche Serum Calibrator. |
| Device description | The Calibrator for Automated Systems (C.f.a.s.) consists of lyophilized 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 Calibrator for Automated Systems (C.f.a.s.) is intended for use as a calibrator of clinical chemistry assays. The material is well suited for automated analytical procedures. |
| Comparison to<br>the predicate<br>device | The Calibrator for Automated Systems (C.f.a.s.) calibrator is substantially<br>equivalent to other products in commercial distribution intended for similar<br>use. Most notably, it is substantially equivalent to the currently marketed<br>Roche Serum Calibrator. |
| | The intended use of this calibrator and the predicate devices is the same in<br>that they are intended to be used for the calibration of test systems for the<br>measurement of their labeled analytes. |
| Substantial<br>equivalence --<br>similarities | The chart below illustrates the similarities between Calibrator for Automated<br>Systems (C.f.a.s.)and the predicate device. |

Continued on next page

.

:

{1}------------------------------------------------

# 510(k) Summary, Continued

Image /page/1/Picture/1 description: The image shows a handwritten alphanumeric string. The string is "K990460". The characters are written in black ink on a white background.

:

### Comparison of predicate device and proposed Calibrator for Automated Systems (C.f.a.s.)

| Characteristic | C.f.a.s.<br>(Modified Device) | Roche Calibrator Serum<br>(Predicate Device) |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For use as a calibrator of clinical chemistry assays for automated analytical procedures. | For use on COBAS systems and manual determinations with Roche reagents to establish points of reference |
| Format | Lyophilized pooled human sera with constituents added as required to obtain desired component levels | Lyophilized pooled human serum with constituents added as required to obtain desired component levels |
| Stability | Stable at 2-8 °C until expiration date Stable 2 days when reconstituted, stoppered, protected from light and stored at 2-8° C, with exceptions noted in labeling. | Stable at 2-8 °C until expiration date Stable 2 days when reconstituted, stoppered, protected from light and stored at 2-8° C, with exceptions noted in labeling. |
| Levels | Single Level | Single Level |

and the comments of the comments of

{2}------------------------------------------------

K9.90460

Substantial equivalence -differences

. "

.

f

ﻟﺴﻤﺮ ﺍ

#### Comparison of predicate device and proposed Calibrator for Automated Systems (C.f.a.s.) .

### Constituent Analytes

| C.f.a.s. (Modificed Device) | Roche Calibrator Serum<br>(Predicate Device) |
|-----------------------------|----------------------------------------------|
| Acid Phosphatase | Acid Phosphatase |
| Alkaline Phosphatase | Alkaline Phosphatase |
| Alanine Aminotransferase | Alanine Aminotransferase |
| α-Amylase | α-Amylase |
| Aspartate Aminotransferase | Aspartate Aminotransferase |
| Cholinesterase | Cholinesterase |
| Creatine Kinase | Creatine Kinase |
| y-Glutamyltransferase | y-Glutamyltransferase |
| Lactate Dehydrogenase | Lactate Dehydrogenase |
| Lipase | Lipase |
| Albumin | Albumin |
| Bilirubin (Direct) | Bilirubin (Direct) |
| Bilirubin (Total) | Bilirubin (Total) |
| Calcium | Calcium |
| Cholesterol | Cholesterol |
| Creatinine | Creatinine |
| Glucose | Glucose |
| Iron | Iron |
| Magnesium | Magnesium |
| Phosphorus (Inorganic) | Phosphorus (Inorganic) |
| Total Protein | Total Protein |
| Triglycerides | Triglycerides |
| Uric Acid | Uric Acid |
| Urea (BUN) | Urea (BUN) |
| Sodium | |
| Potassium | |
| Chloride | |
| Bicarbonate | |
| UIBC | |
| LD1 | |

{3}------------------------------------------------

### DEPARTMENT OF HEALTH & HUMAN SERVICES

MAR 2 2 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Priscilla A. Hamill Requlatory Affairs Consultant Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457

Re: K990460 Trade Name: Calibrator for Automated Systems (C.f.a.s.) Requlatory Class: II Product Code: JIX Dated: February 10, 1999 Received: February 12, 1999

Dear Ms. Hamill:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. this response to your premarket notification Please note: submission does not affect any obliqation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

Image /page/3/Picture/9 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads facing to the right. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.

{4}------------------------------------------------

Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

### 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

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

#### Indications for Use:

For use as a calibrator of clinical chemistry assays. Biological materials are added as required to obtain desired component levels. This calibrator material is well suited for automated analytical procedures. Levels of constituent analytes are provided in product labeling.

K990460

Sean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Review

Division of Clinical Laboratory Devices K990460 510(k) Number_

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IS NEEDED)

NdBDDD)
---------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109)

OR

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional format 1-2-96)