(36 days)
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.
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.
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. The device aids in the rapid diagnosis of heart and renal disease.
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
For an in vitro diagnostic device, performance metrics like precision, measuring range, and lower detection limit are key acceptance criteria. The submission largely compares the performance of the new device to its predicate device rather than explicitly stating specific acceptance criteria thresholds. However, we can infer some criteria from the presented "Within-run precision" and "Between-run precision" values. The method comparison also serves as a crucial criteria, demonstrating agreement with the predicate.
| Characteristic | Acceptance Criteria (Inferred/Compared to Predicate) | Reported Device Performance (Tina-Quant® Myoglobin Gen.2 Test System) |
|---|---|---|
| Intended Use | Substantially equivalent to predicate: quantitative in vitro determination of myoglobin in human serum and plasma on Roche automated clinical chemistry analyzers. | Quantitative in vitro determination of myoglobin in human serum and plasma on Roche automated clinical chemistry analyzers. |
| Indications for Use | Substantially equivalent to predicate: Measurement of myoglobin aids in the rapid diagnosis of heart and renal disease. | Measurement of myoglobin aids in the rapid diagnosis of heart and renal disease. |
| Assay Principle | Substantially equivalent to predicate: Immunoturbidimetry. | Immunoturbidimetry. |
| Instrument Compatibility | Applied to Hitachi family and Integra family analyzers. (Improved compared to predicate which was Hitachi family only). | Hitachi family (including cobas c6000 series) and Integra family analyzers. |
| Reagent Stability (On-board) | Improved/equivalent to predicate's 28 days at 2-8 °C. | 12 weeks opened and refrigerated. (Significantly improved) |
| Reagent Composition | Minor variations in stabilizers in R1, different procedure for coating latex with antibody in R2, but using the same antibody as predicate. Overall, composition should not negatively impact performance. | R1: same except for minor variations in stabilizers; R2: Same antibody but different procedure for coating latex with antibody. |
| Measuring Range | Equivalent or improved compared to predicate (3-560 ug/L, with extended range 3-4500 ng/mL). | Hitachi 902: 30-580 ug/L. Other Hitachi: 20-580 ug/L, 20-5800 ug/L with extended measuring range. (Wider extended range on "Other Hitachi" vs predicate, but higher lower end on Hitachi 902) |
| Lower Detection Limit | Equivalent or lower than predicate (3 ug/L). | Hitachi 902: < 20 ug/L. Other Hitachi: < 15 ug/L. (Higher than predicate) |
| Within-run Precision (%CV) | Should be comparable to or better than predicate (2.6% at 32.3 ug/L, 0.9% at 71.3 ug/L, 0.3% at 471.5 ug/L). Lower %CV indicates better precision. | 1.1% at 36.3 ug/L; 0.7% at 60.9 ug/L; 0.3% at 252 ug/L; 0.7% at 129 ug/L. (Generally improved performance across comparable concentration ranges, especially at lower concentrations). |
| Between-run Precision (%CV) | Should be comparable to or better than predicate (3.3% at 71.4 ug/L, 1.7% at 459.1 ug/L). Lower %CV indicates better precision. | 2.0% at 63.1 ug/L; 1.4% at 240 ug/L; 1.8% at 62.4 ug/L; 1.8% at 265 ug/L. (Generally improved performance across comparable concentration ranges). |
| Interferences | Should demonstrate non-interference or equivalent/improved interference profile compared to predicate. | No significant interference up to: I index of 60 (Bilirubin up to 60 mg/dL); H index of 500 (Hemoglobin up to 500 mg/dL); L index of 500 (Intralipid); Rheumatoid factors up to 100 IU/mL. No interference from 18 commonly used pharmaceuticals. Caveats for gammopathy and high-dose hook effect (>10000 ug/L). (Comparable/expanded data on specific interferents, and new pharmaceutical interference data). |
| Method Comparison (Regression) | Demonstrate strong correlation (high 'r' value) and agreement (slope near 1, intercept near 0) with the predicate device using Passing-Bablok regression. | y = Tina-Quant® Myoglobin Gen.2, x = Tina-Quant Myoglobin. Passing-Bablok results: y = 1.016x + 4.3; T = 0.961; r = 0.992. (Strong correlation and good agreement with a slight positive bias and slope slightly above 1). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the "test set" in the traditional sense of a clinical validation study with patient samples. The performance data presented (precision, measuring range, detection limit, interference, method comparison) come from internal validation studies.
- Precision:
- Within-run precision: Data points provided for 4 different myoglobin concentrations. The document does not specify the number of replicates or runs for each concentration.
- Between-run precision: Data points provided for 4 different myoglobin concentrations. The document does not specify the number of replicates, runs, or days.
- Method Comparison: The Passing-Bablok regression shows
r = 0.992, indicating a strong correlation. However, the exact number of samples (n) used for this comparison is not provided. - Interference: "No interference from 18 commonly used pharmaceuticals." The number of samples/tests for each interfering substance is not specified.
Data Provenance: The document does not explicitly state the country of origin or whether the data is retrospective or prospective. Given it's an in-vitro diagnostic device submission, the data is typically generated in a controlled laboratory setting (prospective) by the manufacturer, Roche Diagnostics, which is based in Indianapolis, IN.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not applicable to immunodiagnostic assays like the Tina-Quant® Myoglobin Gen.2 test system. The "ground truth" for quantitative assays is established by reference methods or by the predicate device (as seen in the method comparison). There are no human "experts" establishing a subjective ground truth for myoglobin concentration. The "ground truth" concentrations are determined by the predicate device or a reference method.
4. Adjudication Method for the Test Set
Not applicable for a quantitative in-vitro diagnostic device measuring a biomarker. The measurements are objective numerical values, not subjective interpretations requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This device is an automated in vitro diagnostic assay, not an AI-assisted diagnostic tool that would involve human "readers" or interpretations in the way an MRMC study evaluates.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is a standalone algorithm/test system. It provides a quantitative result without direct human interpretation of complex images or signals. The "algorithm" is the immunoturbidimetric assay itself, which is performed by automated clinical chemistry analyzers. The performance data presented (precision, measuring range, method comparison) are inherently "standalone" performance metrics of the diagnostic test system. The FDA 510(k) clearance process reviews the test system's performance against established criteria and comparison to a predicate device.
7. The Type of Ground Truth Used
For method comparison, the "ground truth" was the measurements obtained from the predicate device, Tina-Quant® Myoglobin Test System (K972513). The regression equation y = 1.016x + 4.3 where x is the predicate's result, indicates this comparison. For other performance characteristics like precision, the "ground truth" is typically the known concentration of controls or calibrators used in the experiments.
8. The Sample Size for the Training Set
Not applicable. This is a traditional immunodiagnostic assay, not a machine learning or AI-based device that requires a "training set" in that context. The "training" of the assay refers to its development and optimization based on chemical and biological principles.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the machine learning sense. The optimization and validation of the assay's reagents and methods during development would rely on known myoglobin standards and reference methods to ensure accuracy and precision.
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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 Diagnostics9115 Hague RoadIndianapolis, IN 46250317-521-3723Contact Person: Theresa M. AmbroseDate Prepared: May 5, 2006 |
| Device Name | Proprietary name: Tina-Quant ® Myoglobin Gen.2 test system; C.f.a.s. (Calibrator for automated systems) MyoglobinCommon name: Myoglobin Test system, calibratorClassification 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.2Test System | Predicate deviceTina-Quant® Myoglobin TestSystem (K972513) |
|---|---|---|
| Intended Use | for the quantitative in vitrodetermination of myoglobin inhuman serum and plasma onRoche automated clinicalchemistry analyzers | for the quantitative in vitrodetermination of myoglobin inhuman serum and plasma usingautomated clinical chemistryanalyzers |
| Indications foruse | Same | Measurement of myoglobin aids inthe rapid diagnosis of heart andrenal disease. |
| Assay principle | Same | Immunoturbidimetry |
| Instrument | Will be applied to Hitachi family(including cobas c6000 series)and Integra family analzyers | Hitachi family of analyzers |
| ReagentStability | • Unopened kit: up to the statedexpiration date at 2-8 °C• On board the analyzer: 12 weeksopened and refrigerated | • Unopened kit: up to the statedexpiration date at 2-8 °C• On board the analyzer : 28 days at2-8 °C |
| Reagent format | liquid | liquid |
| Reagentcomposition | R1: same except for minorvariations in stabilizersR2: Latex particles, loaded withanti-human myoglobinantibody(rabbit), 0.1% (w/v)glycine buffer 170 mmol/L; NaCl100 mmol/L, preservativeSame antibody but differentprocedure for coating latex withantibody | R1: Glycine buffer:170 mmol/L;NaCl 100 mmol/L, EDTA 50mmol/.L, preservativeR2: Latex particles, loaded withanti-human myoglobinantibody(rabbit), 0.12% (w/v)glycine buffer 170 mmol/L; NaCl100 mmol/L, preservative |
Substantial equivalence: comparison table
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510(k) Summary, Continued, Continued
Predicate devices (continued)
| Characteristic | Tina-Quant ® Myoglobin Gen.2Test System | Predicate deviceTina-Quant ® Myoglobin TestSystem (K972513) |
|---|---|---|
| Sample type | Same | Serum or plasma with Li, Naheparin; or EDTA |
| Calibrator | C.f.a.s Myoglobin | In-kit calibrator |
| Calibratorcomposition | Same | Human myoglobin in a bovineserum albumin matrix |
| Calibratorconfiguration | Provided separately from kit. | Provided with kit |
| Calibratorlevels | One level | Four levels provided |
| Traceability/standardization | Standardized against a selectedmanufacturer's measurementprocedure (immunological method).Results are corrected by + 8 ug/L tomaintain traceability. Performancevalidated using this correction. | NIBSC reagents |
| Controls | same | Myoglobin Control Set |
| Measuringrange | Hitachi 902:30-580 ug/LOther Hitachi: 20-580 ug/L,20-5800 ug/L with extendedmeasuring range | 3-560 ug/L3-4500 ng/ mL with extendedmeasuring range |
| LowerDetection Limit | Hitachi 902: < 20 ug/LOther Hitachi: < 15ug/L | 3 ug/L |
| Within-runprecision(%CV) | 1.1% at 36.3 ug/L0.7% at 60.9 ug/L0.3% at 252 ug/L0.7% at 129 ug/L | 2.6% at 32.3 ug/L0.9% at 71.3 ug/L0.3% at 471.5 ug/L |
| Characteristic | Tina-Quant® Myoglobin Gen.2 Test System | Predicate deviceTina-Quant® Myoglobin Test System (K972513) |
| Between-run precision (%CV) | 2.0% at 63.1 ug/L1.4% at 240 ug/L1.8% at 62.4 ug/L1.8% at 265 ug/L | 3.3% at 71.4 ug/L1.7% at 459.1 ug/L |
| Limitations:interferences | 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)• Rheumatoid factors up to 100 IU/mLNo interference from 18 commonly used pharmaceuticalsIn rare cases gammopathy, in particular type IgM, may cause unreliable results.A high-dose hook effect may occur at myoglobin concentrations >10000 ug/LThe results should always be assessed in conjunction with the patient's medical history, clinical examination and other findings. | No significant interference from• Conjugated and unconjugated bilirubin up to 60 mg/dL• Hemolysis up to 0.5 g/dL hemoglobin• Lipemia up to 1500 mg/dL• Rheumatoid factors up to 100 IU/mL |
| Expected values | Men: 23-72 ug/LWomen: 19-51 ug/L | Men: 16-76 ug/LWomen: 7-64 ug/L |
| Method comparison | y = Tina-Quant® Myoglobin Gen.2x = Tina-Quant Myoglobin$Passing-Bablok results: y=1.016x + 4.3 T = 0.961; r = 0.992$ |
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 (240) 276-0484. 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 (800) 638-2041 or (301) 443-6597 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
§ 866.5680 Myoglobin immunological test system.
(a)
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.(b)
Classification. Class II (performance standards).