← Product Code [DDR](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDR) · K061683 # TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM (K061683) _Roche Diagnostics Corp. · DDR · Jul 21, 2006 · Immunology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-f%E2%80%94immunological-test-systems/DDR/K061683 ## Device Facts - **Applicant:** Roche Diagnostics Corp. - **Product Code:** [DDR](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDR.md) - **Decision Date:** Jul 21, 2006 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.5680 - **Device Class:** Class 2 - **Review Panel:** Immunology ## 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. 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 No clinical data. Bench testing only. Precision studies (n=21 days) showed within-run CV 0.3-1.1% and between-run CV 1.4-2.0%. Linearity established 20-580 µg/L. Method comparison against predicate (n=48) yielded y=1.014x + 3.4 (r=0.996). Matrix comparison (serum vs. Li/Na Heparin, K2/K3-EDTA plasma) met acceptance criteria (slope 0.9-1.1, intercept <±10 µg/L, r>0.98). ## Technological Characteristics Immunoturbidimetric assay. Reagents: glycine buffer (R1) and latex particles coated with anti-human myoglobin antibodies (R2). Calibrator: bovine serum albumin matrix. Analyzers: Roche/Hitachi 904, 911, 912, 917, Cobas c6000, Modular P, Integra. Measuring range: 20-580 µg/L (up to 5800 µg/L extended). Traceability: immunological method with +8 µg/L correction. Interference: no significant interference from bilirubin (60 mg/dL), hemoglobin (500 mg/dL), Intralipid (500 mg/dL), or rheumatoid factors (100 IU/mL). ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 1 # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k061683 B. Purpose for Submission: New device C. Measurand: Myoglobin D. Type of Test: Quantitative, immunoturbidimetric assay E. Applicant: Roche Diagnostics Corp. F. Proprietary and Established Names: Tina-Quant Myoglobin Gen.2 Test System and C.f.a.s. (Calibrator for automated systems) Myoglobin G. Regulatory Information: | Product Code | Classification | Regulation Section | Panel | | --- | --- | --- | --- | | Myoglobin, Antigen, Antiserum, Control (DDR) | Class II | 21 CFR 866.5680, Myoglobin immunological test system. | 82 Immunology(IM) | | Product Code | Classification | Regulation Section | Panel | | Calibrator (JIT) | Class II | 21 CFR 862.1150 Secondary calibrator | 75 Chemistry(CH) | {1} H. Intended Use: 1. Intended use(s): 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. 2. Indication(s) for use: See Intended use above 3. Special conditions for use statement(s): Prescription use only 4. Special instrument requirements: Roche/Hitachi 904, 911, 912, 917, Cobas c6000 series, Modular P analyzers, and Integra family analyzers I. Device Description: The Tina-Quant Myoglobin Gen.2 reagent consists of a dual chambered reagent pack containing two ready-to-use-liquid reagents. R1 consists of glycine buffer and R2 consists of latex particles coated with anti-human myoglobin antibodies. The C.f.a.s. Myoglobin is a one level liquid prepared from bovine serum albumin. This calibrator is used to calibrate Roche clinical chemistry analyzers for the quantitative measurement of Myoglobin. J. Substantial Equivalence Information: The Tina-Quant Myoglobin Gen.2 test system is substantially equivalent to the currently marketed Tina-quant Myoglobin test system cleared under k972513. Similarities and differences between the new device and the predicate are presented in the table below. {2} | Items | Tina-quant Myoglobin Gen.2 test system (New device) | Tina-quant Myoglobin test system (Predicate device) | | --- | --- | --- | | Intended Use | For the quantitative in vitro determination of myoglobin in human serum and plasma on Roche automated clinical chemistry analyzers | For the quantitative in vitro determination of myoglobin in human serum and plasma using automated clinical chemistry analyzers | | Indications for use | Measurement of myoglobin aids in the rapid diagnosis of heart and renal disease | Same | | Assay principle | Immunoturbidimetry | Same | | Instrument | Will be applied to Hitachi family (including cobas c6000 series) and Integra family analyzers | Hitachi family of analyzers | | Sample type | Serum or plasma with Li, Na heparin, or EDTA | Same | | Calibrator | C.f.a.s. Myoglobin | Provided with kit | | Calibrator composition | Human myoglobin in a bovine serum albumin matrix | Same | | Calibrator configuration | Provided separately from kit | Provided with kit | | Calibrator levels | One level | Four levels provided | | Traceability/standardization | Standardized against a selected manufacturer’s measurement procedure (immunological method). Results are corrected by + 8 μg/L to maintain traceability. Performance validated using this correction. | NIBSC (National Biological Standard Board) reagents | | Controls | Myoglobin Control Set | Same | | Measuring range | Hitachi 902:30-580 μg/L Other Hitachi: 20-580 μg/L, 20-5800 μg/L with extended measuring range | 3-560 μg/L, 3-4500 μg/L with extended measuring range | | Lower Detection Limit | Hitachi 902: < 20 μg/L Other Hitachi: <15 μg/L | 3 μg/L | | Reference interval | Men: 23-72 μg/L Women: 19-51 μg/L | Men: 23-72 μg/L Women: 19-51 μg/L | {3} 4 # K. Standard/Guidance Document Referenced (if applicable): | STANDARDS | | --- | | Title and Reference Number | | Use of Anticoagulants in Diagnostic Laboratory Investigations. (WHO/DIL/LAB/99.1 Rev.2 Jan 2002) | | Other Standards | | None | | GUIDANCE | | | | | --- | --- | --- | --- | | Document Title | Office | Division | Web Page | | None | | | | # L. Test Principle: 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. # M. Performance Characteristics (if/when applicable): ## 1. Analytical performance: ### a. Precision/Reproducibility: Precision studies were performed by measuring human samples and controls on the Hitachi 917 analyzer. Samples were run in triplicate, one run per day, for 21 days. The following results were obtained: | | Within-run | | | Between-run | | | | --- | --- | --- | --- | --- | --- | --- | | Sample | Mean | | CV % | Mean | | CV % | | | μg/L | nmol/L | | μg/L | nmol/L | | | Human serum I | 36.3 | 2.07 | 1.1 | 63.1 | 3.60 | 2.0 | | Human serum II | — | — | — | 240 | 13.7 | 1.4 | | Control low | 60.9 | 3.48 | 0.7 | 62.4 | 3.56 | 1.8 | | Control high | 252 | 14.4 | 0.3 | 265 | 15.1 | 1.8 | | Control medium | 129 | 7.37 | 0.7 | — | — | — | ### b. Linearity/assay reportable range: Three sets of dilution series (one fresh unspiked serum, two spiked sera) diluted with saline were measured on the Hitachi 917 analyzer. Each series was measured using three lots of reagent. The linearity data support a linear range of $20 - 580~\mu \mathrm{g / L}$ for the Hitachi 917. {4} c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability: The C.f.a.s. Myoglobin values are traceable to an immunological method. Results are corrected by an additive factor (+8 µg/L) to maintain traceability. Performance was validated using this correction. Stability: A real-time stability study was performed on three lots of C.f.a.s. Myoglobin. Testing interval was done at 21, 23 or 24 months and the calibrator was stored at 2-8°C. At the end of the storage period, the stored C.f.a.s. Myoglobin is compared to values originally obtained using the fresh reference material at the zero time-point. The recovery is calculated as a percentage of the reference value. The average percent recovery is 97%. The open-vial stability was done at 1,3,5,7 weeks interval with bottles opened and closed once a week; and for 1,2,4,6 hrs interval with calibrator opened on the instrument (Hitachi 911). At the end of the respective storage period, the stored controls are compared to the reference material (C.f.a.s. Myoglobin stored at 2-8°C). All measurements were performed in triplicate and the recovery is calculated as a percentage of the reference value. The applicant's acceptance criterion is 90-110% recovery compared to the reference value. d. Detection limit: 20 µg/L Limit of the blank was determined by running 21 replicates of the 0 calibrator on the Hitachi 917. The limit of the blank represents the lowest measurable myoglobin concentration that can be distinguished from zero. It is calculated as the concentration at three standard deviations above that of the lowest standard (0 µg/L). e. Analytical specificity: The anti-myoglobin antibody is specific for the myoglobin protein. Interference and Limitations: | The applicant claims no significant interference up to • I index of 60 (Conjugated and unconjugated bilirubin up to 60 mg/dL) • H index of 500 (Hemoglobin up to 500 mg/dL) • L index of 500 (Intralipid) | | --- | {5} - Rheumatoid factors up to 100 IU/mL The applicant claims no interference from 18 commonly used pharmaceuticals. (All substances tested are defined by the applicant as no significant interference if the % recovery exceeded or equal to ± 10 % of the expected 100% recovery. For drugs interference, the applicant defined no significant interference if the % recovery exceeded or equal to ± 10 % of the expected 100% recovery from the reference value for the lower drug concentration tested.) In rare cases gammopathy, in particular type IgM, may cause unreliable results. A high-dose hook effect may occur at myoglobin concentrations >10,000 µg/L. f. Assay cut-off: Not applicable 2. Comparison studies: a. Method comparison with predicate device: A comparison of the Myoglobin determination using serum on the Roche Tina-Quant Myoglobin Gen.2 assay (y) with the Roche Tina-Quant assay (x) using the Hitachi 917 gave the following correlation: y=1.014x + 3.4, r= 0.996, n=48; samples used ranged from 31.5 µg/L to 522.7 µg/L. Another comparison study between the Roche Tina-Quant Myoglobin Gen.2 assay (y) with the Roche Elecsys Myoglobin STAT assay (x) gave the following correlation: y=0.924x + 4.5, r= 0.991, n=58; samples used ranged from 26.1 µg/L to 347 µg/L. b. Matrix comparison: The matrix studies were performed using the following reference: "Use of Anticoagulants in Diagnostic Laboratory Investigations". WHO/DIL/LAB/99.1 Rev.2 Jan 2002. Paired serum and plasma samples were collected and analyzed using the Hitachi 917 and results were evaluated by linear regression analysis. Additional sample type tested were Li or Na Heparin; K2- or K3-EDTA plasma. The samples used ranged from 23 µg/L to 527 µg/L. All linear regression analysis of the sample types were considered acceptable by the applicant if the slope is 0.9 to 1.10; the intercept is < ± 10 µg/L; and the r 6 {6} >0.98. All correlations met the applicant's stated criteria. 3. Clinical studies: a. Clinical Sensitivity: Not applicable b. Clinical specificity: Not applicable c. Other clinical supportive data (when a. and b. are not applicable): None 4. Clinical cut-off: Not applicable 5. Expected values/Reference range: Expected values for Myoglobin are as follows: Men: 23-72 µg/L; Women: 19-51 µg/L. These data are from a multi-center evaluation using Tina-Quant Myoglobin (the predicate device). The applicant stated that because the predicate device and this device showed similar performance characteristics and met acceptance criteria for method comparison studies, this reference range can be applied to the Myoglobin Gen.2 Test System. N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-f%E2%80%94immunological-test-systems/DDR/K061683](https://fda.innolitics.com/submissions/CH/subpart-f%E2%80%94immunological-test-systems/DDR/K061683) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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