ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS CALIBRATOR CALIBRATOR FOR AUTOMATED SYSTEM

K101456 · Roche Diagnostics · JIX · Sep 8, 2010 · Clinical Chemistry

Device Facts

• Record ID: K101456
• Device Name: ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS CALIBRATOR CALIBRATOR FOR AUTOMATED SYSTEM
• Applicant: Roche Diagnostics
• Product Code: JIX · Clinical Chemistry
• Decision Date: Sep 8, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

1. Calibrator for automated systems (C.f.a.s.) is for use in the calibration for automated Roche methods on Roche chemistry analyzers as specified in the value sheets. 2. C.f.a.s. (Calibrator for automated systems) CK-MB is for use in the calibration of Roche methods for the quantitative determination of CK-MB on Roche clinical chemistry analyzers as specified in the value sheets.

Device Story

Calibrator for automated systems used for clinical chemistry analysis. Modification involves replacing animal-derived enzymes (porcine kidney γ-GT, porcine heart AST, porcine brain CK-BB) with human recombinant equivalents (γ-GT, AST, CK-MB). Includes updates to reference materials (SRM 909b, 956, 929, 914, 967, 1951) and reference method publications (IFCC 2002). Device used in clinical laboratory settings to calibrate automated diagnostic systems. Output provides calibration curves for clinical chemistry assays, enabling accurate patient sample quantification by healthcare providers.

Clinical Evidence

No clinical data. Substantial equivalence supported by design control activities, risk analysis, and verification/validation testing demonstrating that modifications did not alter fundamental scientific technology or performance.

Technological Characteristics

Lyophilized multi-analyte (C.f.a.s.) and single-analyte (C.f.a.s. CK-MB) calibrators. C.f.a.s. base: human serum; C.f.a.s. CK-MB base: bovine serum albumin. Recombinant human proteins used for AST, γGT, and CK-MB. Traceable to SRM 909b, 929, 914, 956, 967, 1951, and IFCC reference methods. Storage: 2-8°C (lyophilized).

Indications for Use

Indicated for use as a calibrator for quantitative Roche clinical chemistry methods on Roche analyzers. C.f.a.s. is a multi-analyte calibrator; C.f.a.s. CK-MB is a single-analyte calibrator for CK-MB determination. No specific patient population or contraindications described.

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 Diagnostics, Calibrator for automated systems (k062319)
• Roche Diagnostics, Calibrator for automated systems CK-MB (k003158)

Submission Summary (Full Text)

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## 510(k) Summary – Calibrator for Automated Systems (C.f.a.s.) and C.f.a.s. CK-MB

| Introduction | Roche Diagnostics Corporation hereby submits this 510(k) to provide notification of modifications to our Calibrator for automated systems (C.f.a.s.) and C.f.a.s. CK-MB.<br><br>1. C.f.a.s. was originally cleared for use in K990460, then modified in K033501 and K062319.<br>2. C.f.a.s. CK-MB was originally cleared for use in K003158.<br><br>Modifications to these devices include changing common source materials for three analytes Human recombinant Gamma-glutamyltransferase (γGT) will replace porcine kidney γGT in C.f.a.s. Human recombinant Aspartate aminotransferase (AST) will replace porcine heart AST in C.f.a.s. Human recombinant Creatine Kinase Isoenzyme MB (CK-MB) will replace porcine brain Creatine Kinase Isoenzyme BB (CK-BB) in C.f.a.s. CK-MB. | |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter name, address, contact | Roche Diagnostics<br>9115 Hague Rd.<br>PO Box 50416<br>Indianapolis, IN 46250<br>Phone: [phone]<br>Fax: [phone]<br><br>Contact Person: Susan Hollandbeck<br><br>Date prepared: June 16, 2010 | |
| | and C.f.a.s. CK-MB, Continued | |
| Device names | Proprietary names:<br>1. Roche Diagnostics Calibrator for automated systems<br>2. Roche Diagnostics Calibrator for automated systems CK-MB | |
| | Common names:<br>1. C.f.a.s.<br>2. C.f.a.s. CK-MB | |
| | Classification names:<br>1. Calibrator, Multi-analyte mixture<br>2. Calibrator, Secondary | |
| | Product Codes:<br>1. JIX<br>2. JIT | |
| Device<br>description | 1. C.f.a.s. is for use in the calibration for automated Roche<br>methods on Roche chemistry analyzers as specified in the<br>enclosed value sheet. It is a lyophilized calibrator based on<br>human serum.<br>2. C.f.a.s. CK-MB is for use in the calibration of Roche methods<br>for the quantitative determination of the MB Isoenzyme of<br>Creatine kinase on automated clinical chemistry analyzers. It<br>is a lyophilized calibrator based on bovine serum albumin. | |
| Intended use | 1. Calibrator for automated systems (C.f.a.s.) is for use in the<br>calibration for automated Roche methods on Roche chemistry<br>analyzers as specified in the value sheets.<br>2. C.f.a.s. (Calibrator for automated systems) CK-MB is for use<br>in the calibration of Roche methods for the quantitative<br>determination of CK-MB on Roche clinical chemistry<br>analyzers as specified in the value sheets. | |
| Predicate<br>devices | We claim substantial equivalence to the following currently marketed<br>devices.<br>1. Calibrator for automated systems cleared in K062319.<br>2. Calibrator for automated systems CK-MB cleared in K003158.<br>Continued on next page | |
| Feature | C.f.a.s<br>(Modified Device) | C.f.a.s. K062319<br>(Predicate Device) |
| Intended Use | Calibrator for automated systems<br>(C.f.a.s.) is for use in the calibration of<br>quantitative Roche methods on Roche<br>clinical chemistry analyzers as<br>specified in the value sheets. | Calibrator for automated systems<br>(C.f.a.s) is for use in the calibration of<br>quantitative Roche methods on Roche<br>clinical chemistry analyzers as<br>specified in the lot specific value<br>sheet. |
| Format | Lyophilized | Same |
| Stability | Lyophilized calibrator<br>2 to 8 °C until expiration date<br><br>Reconstituted calibrator<br>15 to 25 °C for 8 hours<br>2 to 8 °C for 2 days<br>-15 to -25 °C for 4 weeks (when<br>frozen once)<br><br>Total Bilirubin in reconstituted<br>calibrator when stored protected from<br>light<br>15 to 25 °C for 6 hours<br>2 to 8 °C for 1 day<br>-15 to -25 °C for 2 weeks (when<br>frozen once)<br><br>Direct Bilirubin in reconstituted<br>calibrator when stored protected from<br>light<br>15 to 25 °C for 3 hours<br>2 to 8 °C for 8 hours<br>-15 to -25 °C for 2 weeks (when<br>frozen once) | Same |
| Levels | Single level | Same |
| Reagent Composition | Lyophilized human serum with<br>chemical additives and material of<br>biological origin | Same |

Continued on next page

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# 510(k) Summary – Calibrator for Automated Systems (C.f.a.s.)
and C.f.a.s. CK-MB. Continued

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#### 510(k) Summary – Calibrator for Automated Systems (C.f.a.s.) and C.f.a.s. CK-MB, Continued

Tables 1 and 2 compare the features of the modified devices with their Substantial equivalence predicate devices. The first is a comparison of C.f.a.s.; the second is a comparison for C.f.a.s. CK-MB.

Table 1: Comparison of C.f.a.s.

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## 510(k) Summary -- Calibrator for Automated Systems (C.f.a.s.) and C.f.a.s. CK-MB, Continued

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#### Substantial equivalence (continued)

Table 1, continued.

| Feature | C.f.a.s<br>(Modified Device) | C.f.a.s. K062319<br>(Predicate Device) |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Traceability | Traceability for each constituent is<br>described in the reagent system<br>instructions for use. | Same |
| | Additional Reference Materials<br>1. SRM 909b and SRM 956<br>for Calcium<br>2. SRM 929 and SRM 956<br>for Magnesium<br>3. SRM 914 and SRM 967<br>for Creatinine Jaffe<br>4. SRM 909b (IDMS) and SRM 967<br>for Creatinine Plus<br>5. SRM 909b (IDMS) and SRM 1951<br>for Triglycerides GB | Reference Materials<br>1. SRM 909b<br>for Calcium<br>2. SRM 929<br>for Magnesium<br>3. SRM 914<br>for Creatinine Jaffe<br>4. SRM 909b (IDMS)<br>for Creatinine Plus<br>5. SRM 909b (IDMS)<br>for Triglycerides GB |
| | Reference Material Name Changes<br>1. ERM DA470k for Albumin Plus<br>2. Primary Reference Material - USP<br>for Salicylate | Reference Material Names<br>1. CRM 470 for Albumin Plus<br>2. Primary Reference Material<br>for Salicylate |
| | Reference Method Publication Update<br>1. IFCC (2002), Manual for ALT<br>2. IFCC (2002), Manual for AST<br>3. IFCC (2002), Manual for CK<br>4. IFCC (2002), Manual for LD | Reference Method Publications<br>1. IFCC (1985), Manual for ALT<br>2. IFCC (1985), Manual for AST<br>3. IFCC (1991), Manual for CK<br>4. IFCC (1994), Manual for LD |
| Value<br>Assignment | Values to new lots are assigned by<br>running them as samples after<br>calibrating the system with a<br>previously assigned C.f.a.s. lot.<br>Values are verified by using reference<br>material, Master lot C.f.a.s., and<br>previously assigned lots of C.f.a.s. | Same |
| Source<br>Material | Human recombinant yGT<br>Human recombinant AST | Porcine kidney yGT<br>Porcine heart AST |

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## 510(k) Summary – Calibrator for Automated Systems (C.f.a.s.) and C.f.a.s. CK-MB, Continued

| Table 2: Comparison of C.f.a.s. CK-MB | | |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | C.f.a.s. CK-MB<br>(Modified Device) | C.f.a.s. CK-MB K003158<br>(Predicate Device) |
| Intended Use | C.f.a.s. (Calibrator for automated<br>systems) CK-MB is for use in the<br>calibration of Roche methods for the<br>quantitative determination of CK-MB<br>on Roche clinical chemistry analyzers<br>as specified in the value sheets. | C.f.a.s. (Calibrator for automated<br>systems) CK-MB is for use in the<br>calibration of Roche methods for the<br>quantitative determination of CK-MB<br>on automated clinical chemistry<br>analyzers. |
| Format | Lyophilized | Same |
| Stability | Lyophilized calibrator<br>• 2 to 8 °C until expiration date | Lyophilized calibrator<br>• same |
| | Reconstituted calibrator<br>• 15 to 25 °C for 24 hours<br>• 2 to 8 °C for 2 days<br>• -15 to -25 °C for 4 weeks (when<br>frozen once) | Reconstituted calibrator<br>• 15 to 25 °C for 24 hours<br>• 2 to 8 °C for 2 days<br>• -20 °C for 1 month (when frozen<br>once) |
| Levels | Single level | Same |
| Reagent<br>Composition | Lyophilized calibrator based on<br>bovine scrum albumin with chemical<br>additives and material of biological<br>origin. | Same |
| Traceability | Traceability for each constituent is<br>described in the reagent system<br>instructions for use. | Same |
| Value<br>Assignment | Values to new lots are assigned by<br>running them as samples after<br>calibrating the system with a<br>previously assigned C.f.a.s. CK-MB<br>lot. Values are verified by using<br>reference material, Master lot C.f.a.s<br>CK-MB, and previously assigned lots<br>of C.f.a.s. CK-MB. | Same |
| Source<br>material | • Human recombinant CK-MB<br>• Human CK-MM | • Porcine brain CK-BB<br>• Human CK-MM |

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#### 510(k) Summary - Calibrator for Automated Systems (C.f.a.s.) and C.f.a.s. CK-MB, Continued

Constituents Tables 3 and 4 catalog the constituent analytes and their biological . source for both the modified and predicate devices. Table 3 summarizes C.f.a.s., a multi-analyte calibrator. For the modified C.f.a.s., the source material changes for two analytes, AST and yGT.

| Table 3: Constituents of C.f.a.s. | | | |
|-----------------------------------|-------------------------------------|----------------------------------------|-------------------|
| | C.f.a.s<br>(Modified Device) | C.f.a.s. K062319<br>(Predicate Device) | |
| Analyte | Source | Analyte | Source |
| ALT/ALAT | Porcine heart | ALT/ALAT | Same |
| AST/ASAT | Human, recombinant | AST/ASAT | Porcine<br>heart |
| Albumin | Bovine plasma | Albumin | Same |
| Alkaline<br>phosphatase | Human placenta (recombinant) | Alkaline<br>phosphatase | Same |
| Amylase, total | Porcine pancreas | Amylase, total | Same |
| Amylase, pancreatic | Porcine pancreas | Amylase, pancreatic | Same |
| Bilirubin, direct | Endogenous and/or chemical additive | Bilirubin, direct | Same |
| Bilirubin, total | Endogenous and/or chemical additive | Bilirubin, total | Same |
| Calcium | Endogenous and/or chemical additive | Calcium | Same |
| Cholesterol | Bovine plasma | Cholesterol | Same |
| Cholinesterase | Human serum | Cholinesterase | Same |
| Creatine kinase | Rabbit muscle | Creatine kinase | Same |
| Creatinine | Endogenous and/or chemical additive | Creatinine | Same |
| yGT | Human, recombinant | yGT | Porcine<br>kidney |
| Glucose | Endogenous and/or chemical additive | Glucose | Same |
| Iron | Endogenous and/or chemical additive | Iron | Same |
| Lactate | Endogenous and/or chemical additive | Lactate | Same |
| LD (LDH) | Porcine heart | LD (LDH) | Same |
| Lipase | Human pancreas (recombinant) | Lipase | Same |
| Lithium | Chemical additive | N/A1 | |
| Magnesium | Endogenous and/or chemical additive | Magnesium | Same |
| Phosphorus | Endogenous and/or chemical additive | Phosphorus | Same |
| Salicylate | Chemical additive | Salicylate | Same |
| Total Protein | Endogenous and/or chemical additive | Total Protein | Same |
| Triglycerides | Chicken egg yolk | Triglycerides | Same |
| UIBC | Endogenous and/or chemical additive | UIBC | Same |
| Urea/BUN | Endogenous and/or chemical additive | Urea | Same |
| Uric Acid | Endogenous and/or chemical additive | Uric Acid | Same |

¹ C.f.a.s. was cleared as the calibrator in the Lithium test system in K063684. The source for lithium is the same.

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## 510(k) Summary – Calibrator for Automated Systems (C.f.a.s.) and C.f.a.s. CK-MB, Continued

Table 4 summarizes C.f.a.s CK-MB. It is a single analyte calibrator Constituents (continued) that contains two Creatine kinase Isoenzyme sources; CK-MB Isoenzyme is the detected analyte in the test system. For the modified C.f.a.s. CK-MB, the source material changes for one of the two CK Isoenzyme biological additives.

#### Table 4: Constituents of C.f.a.s. CK-MB

| C.f.a.s. CK-MB<br>(Modified Device) | | C.f.a.s. CK-MB K003158<br>(Predicate Device) | |
|-------------------------------------|-------------------------------------------------------------------|----------------------------------------------|---------------------------------------------------------------|
| Analyte | Source | Analyte | Source |
| CK-MB<br>Isoenzyme | • Human recombinant CK-MB<br>Isoenzyme<br>• Human CK-MM Isoenzyme | CK-MB<br>Isoenzyme | • Porcine brain CK-BB<br>Isoenzyme<br>• Human CK-MM Isoenzyme |

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#### Public Health Service

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/7/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Re:

Food & Drug Administration 903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

Roche Diagnostics c/o Susan Hollandbeck Regulatory Affairs Consultant 9115 Hague Road, P.O. Box 50416 Indianapolis, IN, 46250-0416

8 2010 SEP

k101456 Trade Names: Calibrator for automated systems (C.f.a.s.) Calibrator for automated systems CK-MB (C.f.a.s. CK-MB) Regulation Number: 21 CFR §862.1150 Regulation Name: Calibrator, Multi-Analyte Mixture and Calibrator, Secondary Regulatory Class: Class II Product Codes: JIX, JIT Dated: August 23. 2010 Received: August 24, 2010

Dear Mr. Hollandbeck:

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 class II (Special Controls), 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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

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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 Parts 801 and 809), 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" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to .

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Signature

Courtney C. Harper, 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 Form

K101456
SEP 08 2010

510(k) Number (if known): k 101456

Device Name:

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 Roche methods on Roche clinical chemistry analyzers as specified in the value sheets.

Prescription Use メ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carlos

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K101456

Page 1 of 1

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## Indications for Use Form

510(k) Number (if known): K101456

Device Name:

K101456

SEP 08 2010

Calibrator for automated systems (C.f.a.s.) CK-MB

Indications for Use:

C.f.a.s. (Calibrator for automated systems) CK-MB is for use in the calibration of Roche methods for the quantitative determination of CK-MB on Roche clinical chemistry analyzers as specified in the value sheets.

Prescription Use メ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Davis

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K101456

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