(36 days)
Not Found
No
The device description and performance studies focus on a standard immunoturbidimetric assay and its analytical performance metrics, with no mention of AI or ML.
No
This device is an in vitro diagnostic test system that measures myoglobin levels, and its stated purpose is to aid in diagnosis, not to treat a condition.
Yes.
The device determines the quantitative in vitro determination of myoglobin in human serum and plasma, which aids in the rapid diagnosis of heart and renal disease. This aligns with the definition of a diagnostic device as it provides information used to identify a disease or medical condition.
No
The device description clearly states it is an "immunoturbidimetric assay" and involves "latex-bound anti-myoglobin antibodies" reacting with antigen in a sample. This indicates a chemical/biological assay, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states "for the quantitative in vitro determination of myoglobin in human serum and plasma". The term "in vitro" is a key indicator of an IVD. It also mentions aiding in the diagnosis of heart and renal disease, which is a diagnostic purpose.
- Device Description: The description details an "immunoturbidimetric assay" which is a laboratory test performed outside of the body using biological samples (serum and plasma). This further confirms its nature as an IVD.
- Calibration and Control Materials: The mention of a calibrator (C.f.a.s. Myoglobin) and control material (Myoglobin Control Set) are standard components of IVD test systems used to ensure accuracy and reliability.
- Performance Studies: The summary of performance studies, including precision and method comparison, are typical evaluations for IVD devices to demonstrate their analytical performance.
- Predicate Device: The identification of a predicate device (K972513; Tina-Quant ® Myoglobin Test System) indicates that this device is being compared to a previously cleared IVD.
All of these elements strongly support the classification of this device as an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
DDR, JIT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
0
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 |
| 9115 Hague Road | |
| Indianapolis, IN 46250 | |
| 317-521-3723 |
Contact Person: Theresa M. Ambrose
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
Common name: Myoglobin Test system, calibrator
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. |
1
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
Test System | Predicate device
Tina-Quant® Myoglobin Test
System (K972513) |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 | Same | Measurement of myoglobin aids in
the rapid diagnosis of heart and
renal disease. |
| Assay principle | Same | Immunoturbidimetry |
| Instrument | Will be applied to Hitachi family
(including cobas c6000 series)
and Integra family analzyers | Hitachi family of analyzers |
| Reagent
Stability | • Unopened kit: up to the stated
expiration date at 2-8 °C
• On board the analyzer: 12 weeks
opened and refrigerated | • Unopened kit: up to the stated
expiration date at 2-8 °C
• On board the analyzer : 28 days at
2-8 °C |
| Reagent format | liquid | liquid |
| Reagent
composition | R1: same except for minor
variations in stabilizers
R2: Latex particles, loaded with
anti-human myoglobin
antibody(rabbit), 0.1% (w/v)
glycine buffer 170 mmol/L; NaCl
100 mmol/L, preservative
Same antibody but different
procedure for coating latex with
antibody | R1: Glycine buffer:170 mmol/L;
NaCl 100 mmol/L, EDTA 50
mmol/.L, preservative
R2: Latex particles, loaded with
anti-human myoglobin
antibody(rabbit), 0.12% (w/v)
glycine buffer 170 mmol/L; NaCl
100 mmol/L, preservative |
Substantial equivalence: comparison table
2
510(k) Summary, Continued, Continued
Predicate devices (continued)
| Characteristic | Tina-Quant ® Myoglobin Gen.2
Test System | Predicate device
Tina-Quant ® Myoglobin Test
System (K972513) |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sample type | Same | Serum or plasma with Li, Na
heparin; or EDTA |
| Calibrator | C.f.a.s Myoglobin | In-kit calibrator |
| Calibrator
composition | Same | Human myoglobin in a bovine
serum albumin matrix |
| 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 ug/L to
maintain traceability. Performance
validated using this correction. | NIBSC reagents |
| Controls | same | Myoglobin Control Set |
| Measuring
range | Hitachi 902:30-580 ug/L
Other Hitachi: 20-580 ug/L,
20-5800 ug/L with extended
measuring range | 3-560 ug/L
3-4500 ng/ mL with extended
measuring range |
| Lower
Detection Limit | Hitachi 902: 10000 ug/L
The 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/L
Women: 19-51 ug/L | Men: 16-76 ug/L
Women: 7-64 ug/L |
| Method comparison | y = Tina-Quant® Myoglobin Gen.2
x = Tina-Quant Myoglobin
$Passing-Bablok results: y=1.016x + 4.3 T = 0.961; r = 0.992$ | |
Continued on next page
3
510(k) Summary, Continued, Continued
Predicate devices (continued)
4
Image /page/4/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a serif font. The text is centered in the image and is the only element present.
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff entwined by two snakes and topped with wings. The text "U.S. Department of Health and Human Services" is arranged in a circular pattern around the caduceus.
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).
5
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
6
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
7
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