TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM

K061683 · Roche Diagnostics Corp. · DDR · Jul 21, 2006 · Immunology

Device Facts

• Record ID: K061683
• Device Name: TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM
• Applicant: Roche Diagnostics Corp.
• Product Code: DDR · Immunology
• Decision Date: Jul 21, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5680
• Device Class: Class 2

Intended Use

The Tina-Quant ® Myoglobin Gen.2 Test System is an immunoturbidimetric assay for the quantitative in vitro determination of myoglobin in human serum and plasma on Roche automated clinical chemistry analyzers. Measurement of myoglobin aids in the rapid diagnosis of heart and renal disease. C.f.a.s. (Calibrator for automated systems) Myoglobin is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet.

Device Story

Tina-Quant Myoglobin Gen.2 is an immunoturbidimetric assay for quantitative myoglobin measurement in human serum/plasma. Input: patient serum/plasma samples. Principle: latex-bound anti-myoglobin antibodies (rabbit) react with sample antigen; agglutination measured turbidimetrically on Roche automated clinical chemistry analyzers (e.g., Hitachi, cobas c6000). Output: quantitative myoglobin concentration (ug/L). Used in clinical laboratory settings by trained technicians. Results interpreted by physicians alongside medical history and clinical findings to aid diagnosis of heart and renal disease. Benefits: provides rapid, automated diagnostic information for cardiac/renal assessment.

Clinical Evidence

Bench testing only. Performance validated via precision studies (within-run CV 0.3-1.1%, between-run CV 1.4-2.0%), measuring range (20-5800 ug/L), and interference testing (bilirubin, hemoglobin, Intralipid, rheumatoid factors). Method comparison against predicate showed y=1.016x + 4.3 (r=0.992). No clinical prospective/retrospective studies provided.

Technological Characteristics

Immunoturbidimetric assay. Reagents: R1 (glycine buffer, NaCl, EDTA, preservative); R2 (latex particles coated with rabbit anti-human myoglobin antibody, glycine buffer, NaCl, preservative). Liquid format. Automated optical measurement. Standardized against manufacturer's procedure with +8 ug/L correction. Compatible with Hitachi and cobas c6000 series analyzers.

Indications for Use

Indicated for quantitative in vitro determination of myoglobin in human serum and plasma to aid in rapid diagnosis of heart and renal disease. For prescription use on Roche automated clinical chemistry analyzers.

Regulatory Classification

Identification

A myoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the myoglobin (an oxygen storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.

Predicate Devices

• Tina-Quant Myoglobin Test System (K972513)

Submission Summary (Full Text)

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Ka61683

# 510(k) Summary

.

JUL 2 1 2006

| 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 Road<br>Indianapolis, IN 46250<br>317-521-3723<br><br>Contact Person: Theresa M. Ambrose<br><br>Date Prepared: May 5, 2006 |
| Device Name | Proprietary name: Tina-Quant ® Myoglobin Gen.2 test system; C.f.a.s. (Calibrator for automated systems) Myoglobin<br><br>Common name: Myoglobin Test system, calibrator<br><br>Classification name: Myoglobin immunological test system; Calibrator, secondary |
| Predicate devices | The Tina-Quant® Myoglobin Gen.2 test system is substantially equivalent to the currently marketed Tina-Quant ® Myoglobin Test System cleared under K972513. |
| Device Description | The Tina-Quant® Gen.2 Test System is an immunoturbidimetric assay for the quantitative in vitro determination of myoglobin in human serum and plasma on Roche automated clinical chemistry analyzers. In this immunoturbidimetric method, latex-bound anti-myoglobin antibodies react with antigen in the sample to form an antigen/antibody complex which after agglutination can be determined turbidimetrically. The calibrator is C.f.a.s. Myoglobin and the recommended control material is the Myoglobin Control Set. |

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## 510(k) Summary, Continued

Intended use The Tina-Quant® Gen.2 Test System is an immunoturbidimetric assay for the quantitative in vitro determination of myoglobin in human serum and plasma on Roche automated clinical chemistry analyzers. C.f.a.s. (calibrator for automated systems) Myoglobin is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed values sheet.

Comparison to The below table compares the Tina-Quant ® Myoglobin Gen.2 Test System predicate with the predicate device, Tina-Quant ® Myoglobin Test System (K972513) device

| Characteristic | Tina-Quant® Myoglobin Gen.2<br>Test System | Predicate device<br>Tina-Quant® Myoglobin Test<br>System (K972513) |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | for the quantitative in vitro<br>determination of myoglobin in<br>human serum and plasma on<br>Roche automated clinical<br>chemistry analyzers | for the quantitative in vitro<br>determination of myoglobin in<br>human serum and plasma using<br>automated clinical chemistry<br>analyzers |
| Indications for<br>use | Same | Measurement of myoglobin aids in<br>the rapid diagnosis of heart and<br>renal disease. |
| Assay principle | Same | Immunoturbidimetry |
| Instrument | Will be applied to Hitachi family<br>(including cobas c6000 series)<br>and Integra family analzyers | Hitachi family of analyzers |
| Reagent<br>Stability | • Unopened kit: up to the stated<br>expiration date at 2-8 °C<br>• On board the analyzer: 12 weeks<br>opened and refrigerated | • Unopened kit: up to the stated<br>expiration date at 2-8 °C<br>• On board the analyzer : 28 days at<br>2-8 °C |
| Reagent format | liquid | liquid |
| Reagent<br>composition | R1: same except for minor<br>variations in stabilizers<br>R2: Latex particles, loaded with<br>anti-human myoglobin<br>antibody(rabbit), 0.1% (w/v)<br>glycine buffer 170 mmol/L; NaCl<br>100 mmol/L, preservative<br>Same antibody but different<br>procedure for coating latex with<br>antibody | R1: Glycine buffer:170 mmol/L;<br>NaCl 100 mmol/L, EDTA 50<br>mmol/.L, preservative<br>R2: Latex particles, loaded with<br>anti-human myoglobin<br>antibody(rabbit), 0.12% (w/v)<br>glycine buffer 170 mmol/L; NaCl<br>100 mmol/L, preservative |

### Substantial equivalence: comparison table

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# 510(k) Summary, Continued, Continued

Predicate devices (continued)

| Characteristic | Tina-Quant ® Myoglobin Gen.2<br>Test System | Predicate device<br>Tina-Quant ® Myoglobin Test<br>System (K972513) |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sample type | Same | Serum or plasma with Li, Na<br>heparin; or EDTA |
| Calibrator | C.f.a.s Myoglobin | In-kit calibrator |
| Calibrator<br>composition | Same | Human myoglobin in a bovine<br>serum albumin matrix |
| Calibrator<br>configuration | Provided separately from kit. | Provided with kit |
| Calibrator<br>levels | One level | Four levels provided |
| Traceability/<br>standardization | Standardized against a selected<br>manufacturer's measurement<br>procedure (immunological method).<br>Results are corrected by + 8 ug/L to<br>maintain traceability. Performance<br>validated using this correction. | NIBSC reagents |
| Controls | same | Myoglobin Control Set |
| Measuring<br>range | Hitachi 902:30-580 ug/L<br>Other Hitachi: 20-580 ug/L,<br>20-5800 ug/L with extended<br>measuring range | 3-560 ug/L<br>3-4500 ng/ mL with extended<br>measuring range |
| Lower<br>Detection Limit | Hitachi 902: < 20 ug/L<br>Other Hitachi: < 15ug/L | 3 ug/L |
| Within-run<br>precision<br>(%CV) | 1.1% at 36.3 ug/L<br>0.7% at 60.9 ug/L<br>0.3% at 252 ug/L<br>0.7% at 129 ug/L | 2.6% at 32.3 ug/L<br>0.9% at 71.3 ug/L<br>0.3% at 471.5 ug/L |
| Characteristic | Tina-Quant® Myoglobin Gen.2 Test System | Predicate device<br>Tina-Quant® Myoglobin Test System (K972513) |
| Between-run precision (%CV) | 2.0% at 63.1 ug/L<br>1.4% at 240 ug/L<br>1.8% at 62.4 ug/L<br>1.8% at 265 ug/L | 3.3% at 71.4 ug/L<br>1.7% at 459.1 ug/L |
| Limitations:<br>interferences | No significant interference up to<br>• I index of 60 (Conjugated and unconjugated bilirubin up to 60 mg/dL)<br>• H index of 500 (Hemoglobin up to 500 mg/dL)<br>• L index of 500 (Intralipid)<br>• Rheumatoid factors up to 100 IU/mL<br><br>No interference from 18 commonly used pharmaceuticals<br><br>In rare cases gammopathy, in particular type IgM, may cause unreliable results.<br><br>A high-dose hook effect may occur at myoglobin concentrations >10000 ug/L<br><br>The results should always be assessed in conjunction with the patient's medical history, clinical examination and other findings. | No significant interference from<br>• Conjugated and unconjugated bilirubin up to 60 mg/dL<br>• Hemolysis up to 0.5 g/dL hemoglobin<br>• Lipemia up to 1500 mg/dL<br>• Rheumatoid factors up to 100 IU/mL |
| Expected values | Men: 23-72 ug/L<br>Women: 19-51 ug/L | Men: 16-76 ug/L<br>Women: 7-64 ug/L |
| Method comparison | y = Tina-Quant® Myoglobin Gen.2<br>x = Tina-Quant Myoglobin<br>$Passing-Bablok results: y=1.016x + 4.3 T = 0.961; r = 0.992$ | |

Continued on next page

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# 510(k) Summary, Continued, Continued

### Predicate devices (continued)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Theresa Ambrose Bush, Ph.D., DABCC, RAC Principal Roche Diagnostics Corp. 9115 Hague Rd. Indianapolis, IN 46250

JUL 2 1 2006

Re: k061683

Trade/Device Name: Tina-Quant® Myoglobin Gen.2 Test System C.f.a.s. (Calibrator for automated systems) Myoglobin Regulation Number: 21 CFR§866.5680 Regulation Name: Myoglobin immunological test system Regulatory Class: Class II Product Code: DDR, JIT Dated: June 15, 2006 Received: June 15, 2006

Dear Dr. Bush;

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 [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,

Alberto G

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):

Device Name: Tina-Quant ® Myoglobin Gen.2 Test System

Indications For Use:

The Tina-Quant ® Myoglobin Gen.2 Test System is an immunoturbidimetric assay for the quantitative in vitro determination of myoglobin in human serum and plasma on Roche automated clinical chemistry analyzers. Measurement of myoglobin aids in the rapid diagnosis of heart and renal disease.

Prescription Use XXXX (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)

Carol (Berman

---

on Sign-Off

Tice of In Vitro Diagnostic Devices

- · Juation and Safety
1400/483

Page 1 of 2

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## Indications for Use

510(k) Number (if known):

#### Device Name: C.f.a.s. (Calibrator for automated systems) Myoglobin

Indications For Use:

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

Prescription Use XXXX (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)

Carol Benson

Page 2 of 2

Jusion Sign-Cit

Office of In V tre Disunostic Device Evaluation and Safer

K061683