(37 days)
No
The summary describes a standard in vitro diagnostic assay for measuring myoglobin levels using chemical reagents and an automated chemistry system. There is no mention of AI, ML, or any computational analysis beyond basic quantitative measurement and statistical analysis of performance characteristics.
No
Explanation: This device is an in vitro diagnostic (IVD) device used for the quantitative measurement of myoglobin in human serum or plasma to aid in the diagnosis of heart or renal disease. It is a diagnostic tool, not a therapeutic device.
Yes
The "Intended Use / Indications for Use" section explicitly states that the assay "aids in the rapid diagnosis of heart or renal disease," which is a diagnostic purpose.
No
The device description explicitly states it includes "ready-to-use liquid reagents" and a "human serum based product containing myoglobin derived from human heart source," which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use Statement: The very first sentence explicitly states: "The ADVIA® Chemistry Myoglobin assay is for in vitro diagnostic use..."
- Device Description: The description details reagents and calibrators used to perform a test on human serum or plasma, which are biological samples tested in vitro (outside the body).
- Purpose: The assay is used for the "quantitative measurement of myoglobin in human serum or plasma," and this measurement "aids in the rapid diagnosis of heart or renal disease." This clearly indicates a diagnostic purpose.
- Calibrator: The calibrator is also described as being for "in vitro diagnostic use."
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ADVIA® Chemistry Myoglobin assay is for in vitro diagnostic use in the quantitative measurement of myoglobin in human serum or plasma on the ADVIA® Chemistry systems. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.
The ADVIA Chemistry Myoglobin calibrator is for in vitro diagnostic use in the calibration of ADVIA® Chemistry system for Myoqlobin assay.
Product codes (comma separated list FDA assigned to the subject device)
DDR, JIT
Device Description
The Myoglobin reagents are ready-to-use liquid reagents packaged for use on the automated ADVIA 1650 Chemistry system. They are supplied as a 100 tests/wedge, 2 wedges/kit. ADVIA Chemistry Myoglobin calibrator is a single analyte, human serum based product containing myoglobin derived from human heart source. The kit consists of 1 vial each of 4 calibrator levels which are lyophilized. The target concentrations of these calibrators are 50, 100, 200, and 720 ng/mL. The volume per vial (after reconstitution with deionized water) is 1.0 mL. Deionized water is recommended to be used as a zero calibrator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Substantial equivalence was demonstrated by testing several performance characteristics including imprecision, method comparison, interfering substances and analytical range. All of the evaluation studies gave acceptable results when compared to the predicate device. These studies support that the ADVIA® 1650 Chemistry Myoglobin Assay is substantially equivalent to the predicate device.
Precision: Within run and Total Precision were established by assaying serum sample pools and serum based controls. Each sample was assayed 2 replicates per run, 2 runs per day, for at least 20 days (Serum Pool 1 was assayed over a period of 5 days in a separate study). Precision estimates were computed according to CLSI document EP05-A2, Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline.
Linearity/Assay Reportable Range: A linearity study across the entire measuring range was assessed using low and high serum pools. The low and high pools were mixed to make nine (9) intermediate levels and additional 2 levels at the low end of the assay. All samples were tested on the ADVIA 1650 Chemistry analyzer. The range of samples tested was from 13-817 ng/mL. The observed values were compared to the expected values. Linear/measuring range of the assay is 22 to 680 ng/mL.
Limit of Blank, Limit of Detection, Limit of Quantitation: The estimations of the Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantitation (LoQ) were performed according to CLSI guideline EP17-A, Protocols for Determination of Limits of Detection and Limits of Quantitation, by running 160 replicates of "zero" serum pool and several serum pools with myoglobin concentration up to 4 x LOD level. Data supports the following claims: LoB = 12 ng/mL, LoD = 21 ng/mL. LoQ = 22 ng/mL.
Method and Matrix Comparison with Predicate Device: The performance of the ADVIA 1650 Chemistry Myoglobin assay (y) for serum samples was compared with the performance of ADVIA Centaur Myoglobin assay (x). Seventy-one serum samples were tested. One sample was removed from calculations for being out of assay range. The sample results ranged from 19.9 - 684.0 ng/mL myoglobin (x), and gave a correlation coefficient of 0.99. The results calculated using least squares linear regression (1st replicate) are as follows: ADVIA 1650 Chemistry Myoglobin = 0.96 (predicate device) + 12.5 ng/mL Slope 95%CI: 0.95 - 0.98 Intercept 95% Cl: 8.3 – 16.7.
Matrix Comparison with Predicate Device (Plasma): The performance of the ADVIA 1650 Chemistry assay (v) for plasma samples on ADVIA 1650 was compared with the performance of ADVIA Centaur Myoglobin assay (x). Sixty four plasma samples were tested; the sample results ranged from 18.9 - 624.1 ng/mL myoglobin (x), and gave a correlation coefficient of 0.99. The results calculated using linear regression (1st replicate) are as follows: ADVIA 1650 Chemistry Myoglobin = 0.98 (predicate device) + 14.1 ng/mL Slope 95%CI: 0.96 - 1.00 Intercept 95% Cl: 8.1 - 20.1.
Analytical Specificity: Interferences from icterus, lipemia, hemolysis, total protein and rheumatoid factor were evaluated. No significant interference was found at various levels of unconjugated bilirubin, conjugated bilirubin, Intralipid, hemoglobin, total protein, and rheumatoid factor. Hemolysed samples should not be used.
Reference Range: The reference range for the assay is
§ 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
510(k) Summary of Safety and Effectiveness for the ADVIA® 1650 Chemistry Myoglobin Assay
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
A. 510(k) Number:
B. Date of Preparation: 08/24/2012
C. Proprietary and Established Names:
ADVIA® Chemistry Myoglobin (MYO) Assay ADVIA® Chemistry Myoqlobin Calibrator
D. Applicant
Contact: Kira Gordon, PhD Regulatory Affairs Address: Siemens Healthcare Diagnostics, Inc 511 Benedict Ave, Tarrytown, NY 10591 (914) 524-2996 Phone:
E. Regulatory Information:
Reagent
-
- Regulation section: 21 CFR §866.5680, Myoglobin immunological test system
-
- Classification: Class II
-
- Product Code: DDR
-
- Panel: Immunology
Calibrator
-
- Requlation section: 21 CFR §862.1150, Calibrator, secondary
-
- Classification: Class II ·
-
- Product Code: JIT
-
- Panel: Clinical Chemistry
ОСТ
קומר ב
1
F. Predicate Device:
Reagent
-
- Device Name: ADVIA Centaur Myoglobin Reagent
-
- Common Name: ADVIA Centaur Myoglobin Reagent
-
- Manufacturer: Siemens Healthcare Diagnostics Inc. Calibrator
-
- Device Name: Dimension Clinical Chemistry System Myoglobin Calibrator
-
- Common Name: Dimension Clinical Chemistry System Myoglobin Calibrator
-
- 510(k) Number: K984193
-
- Manufacturer: Siemens Healthcare Diagnostics Inc.
G. Intended Use:
The ADVIA® Chemistry Myoqlobin assay is for in vitro diagnostic use in the quantitative measurement of myoglobin in human serum or plasma on the ADVIA® Chemistry systems. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.
The ADVIA Chemistry Myoglobin calibrator is for in vitro diagnostic use in the calibration of ADVIA® Chemistry system for Myoqlobin assay.
H. Device Description:
The Myoglobin reagents are ready-to-use liquid reagents packaged for use on the automated ADVIA 1650 Chemistry system. They are supplied as a 100 tests/wedge, 2 wedges/kit. ADVIA Chemistry Myoglobin calibrator is a single analyte, human serum based product containing myoglobin derived from human heart source. The kit consists of 1 vial each of 4 calibrator levels which are lyophilized. The target concentrations of these calibrators are 50, 100, 200, and 720 ng/mL. The volume per vial (after reconstitution with deionized water) is 1.0 mL. Deionized water is recommended to be used as a zero calibrator.
l. Test Principle:
In the ADVIA 1650 Chemistry Myoglobin assay, sample is diluted and then mixed with the R1 reagent (a buffer), followed by an addition of the R2 reagent (which contains latex particles coated with antibodies specific for myoglobin). The formation of the
2
antibody-antigen complex during the reaction results in an increase in turbidity, which is measured at 571 nm. By constructing a standard curve from the absorbance of standards, myoglobin concentration of sample can be determined.
J. Substantial Equivalence Information:
| Reagent | |
|---|---|
| Reagent
Item | New Device:
ADVIA 1650 Chemistry
Myoglobin | Predicate Device:
ADVIA Centaur Myoglobin |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Analyte | Myoglobin | Same |
| Intended
Use/Indications for Use | For in vitro diagnostic use in
the quantitative measurement
of myoglobin. Measurement of
myoglobin aids in the rapid
diagnosis of heart or renal
disease | Same - For in vitro
diagnostic use in the
quantitative determination
of myoglobin in serum or
plasma and as an aid in the
diagnosis of acute
myocardial infarction |
| Measurement | quantitative | Same |
| Sample type | Serum , Heparinized Plasma | Same |
| Reference interval | 10% variance from the control. No significant interference was found at unconjugated bilirubin levels from 0-60 mg/dL in 50. 100. and 400 ng/mL myoglobin samples. No significant interference
5
was found at coniugated bilirubin levels from 0-60 mg/dL in 50. 100. and 400 ng/mL mvoglobin samples. No significant lipemia interference was found at Intralipid levels from 0-1000 mg/dL in a 100 and 400 ng/mL myoglobin samples, and at Intralipid levels from 0-750 mg/dL in a 50 ng/mL myoglobin sample. No significant hemoglobin interference was found at hemoglobin levels from 0-1000 mg/dL in a 400 ng/mL myoglobin sample, at hemoglobin levels from 0-500 mg/dL in a 100 ng/mL myoqlobin sample, and at hemoglobin levels from 0-250 mg/dL in a 50 ng/mL myoglobin sample. Hemolysed samples should not be used. No significant interference was found at total protein levels from 0-13 g/dL in a 50, 100, and 400 ng/mL myoglobin samples. No significant interference was found at RF levels from 0-800 U/L in a 50, 100, and 400 na/mL myoglobin samples.
VII. Reference Range
The reference range for the assay is Trade Name: ADVIA® Chemistry Myoglobin Assay ADVIA® Chemistry Myoglobin Calibrator Regulation Number: 21 CFR §866.5680 Regulation Name: Myoglobin immunological test system Regulatory Class: Class II Product Codes: DDR, JIT Dated: August 24, 2012 Received: August 27, 2012
Dear Dr. Gordon:
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); 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).
OCT
3 2012
7
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you dosn't spocently as vitro Diagnostic Devices and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" Also, prease note the regarding postmarket surveillance, please contact CDRY'S (21 Of R Pat 001197). 1 0 Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-576-. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/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 Tou thay of Small Manufacturers, International and Consumer Assistance at its toll-free number (800 638-2041 or (301) 796-5680 or at its Internet address http://www.fda/gov/MedicalDevices/ResourcesforYou/Industry/default.htm
Sincerely yours,
Courtney H. Lias, Ph.D Director Division of Chemistry and Toxicology Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
8
Indication for Use
510(k) Number (if known): K122599
Device Name:
ADVIA® Chemistry Myoglobin Assay
ADVIA® Chemistry Myoglobin Calibrator
Indication For Use:
The ADVIA® Chemistry Myoglobin assay is intended for in vitro diagnostic use in the quantitative measurement of myoglobin in human serum or plasma on the ADVIA® Chemistry systems. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.
The ADVIA Chemistry Myoglobin calibrator is intended for in vitro diagnostic use in the calibration of ADVIA® Chemistry system for Myoglobin assay
Prescription Use X (21 CFR Part 801 Subpart D) . And/Or
Over the Counter Use _ (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Ruta Chester
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
5 9 1 ನ 10(k)