(21 days)
Not Found
No
The device description details a standard immunoturbidometric assay based on chemical reactions and optical density measurements. There is no mention of AI, ML, image processing, or any computational learning components. The performance studies focus on traditional analytical chemistry metrics.
No.
This device is an in vitro diagnostic assay used for the quantitative determination of Myoglobin, aiding in diagnosis rather than providing therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that "Measurement of myoglobin aids in the rapid diagnosis of heart and renal disease." This indicates the device is used to help identify or determine the presence of a disease.
No
The device is a laboratory assay that uses chemical reagents and an automated clinical chemistry analyzer to measure myoglobin levels, indicating it is a hardware-based diagnostic test, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of Myoglobin in serum and plasma." This involves testing biological samples (serum and plasma) outside of the body.
- Device Description: The description details a laboratory-based assay using reagents (EDTA/glycine buffer, latex particles coated with antibodies) to analyze a blood sample. This is characteristic of an in vitro diagnostic test.
- Measurement Method: The method is "turbidimetric immunoinhibition," which is a common technique used in clinical laboratories to measure substances in biological fluids.
- Clinical Chemistry Analyzers: The assay is designed for use on "automated clinical chemistry analyzers," which are standard equipment in clinical laboratories for performing in vitro diagnostic tests.
- Diagnosis of Disease: The intended use states that the measurement "aids in the rapid diagnosis of heart and renal disease," indicating a medical purpose for the test results.
All these factors align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility of transfused blood, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
The Tina-quant® Myoglobin Assay is an immunoturbidometric assay for the quantitative determination of Myoglobin in serum and plasma using automated clinical chemistry analyzers. Measurement of myoglobin aids in the rapid diagnosis of heart and renal disease.
Product codes (comma separated list FDA assigned to the subject device)
DDR
Device Description
The myoglobin determination is based upon turbidimetric immunoinhibition (TINIA) using a serum or plasma blood sample. The sample containing myoglobin is transferred into a EDTA/glycine buffer solution (R1 reagent). In the second step, an aliquot of solution containing fine latex particles coated with polyclonal anti-human myoglobin antibodies (R2 reagent) is added to mixture of the first step. The antibody-coated particles will bind to the myoglobin in the sample to form "aggregates" such that the amount of aggregate formed is proportionate to the amount of myoglobin present in the sample. The resulting agglutination complex is measured turbidimetrically whereby increased turbidity is reflected through an increase in optical density. Therefore, the amount of myoglobin in the sample is directly proportional to the amount of turbidity formed.
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)
Performance Characteristics:
Precision:
Intra-Assay Precision (ng/mL):
Level: Control 1, Control 2, Control 3
N: 20, 20, 20
Mean: 32.3, 71.3, 471.5
SD: 0.8, 0.6, 1.6
%CV: 2.6, 0.9, 0.3
Inter-Assay Precision (ng/mL):
Level: Sample 1, Sample 2
N: 20, 20
Mean: 71.3, 471.5
SD: 0.6, 1.6
%CV: 0.9, 0.3
Lower Detection Limit: 3.0 ng/mL
Linearity: 3.0 - 560 ng/mL
Method Comparison:
Vs N Latex® Myoglobin:
Least Squares: y = 1.06x + 0.35, r = 0.989, SEE = 19.61, N = 41
Passing/Bablok: y = 1.07x + 3.6, r = 0.989, SEE = 13.61, N = 41
Interfering substances: No interference at: Bilirubin 60 mg/dL, Hemoglobin 0.5 g/dL, Lipemia 1500 mg/dL, Rheumatoid Factor 100 IU/mL.
Specificity (% Cross-reactivity): Human cardiac myoglobin 102.4%, Human skeletal myoglobin 99.7%, Hemoglobin 0.0, Human IgG 0.0, Human Serum Albumin 0.0.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key Metrics presented include Precision (Intra-Assay and Inter-Assay %CV, SD, Mean), Lower Detection Limit, Linearity, and % Cross-reactivity for specificity.
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.
Not Found
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).
Not Found
§ 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
JUL 2 8 1997
.
ﺴﺴ
| 510(k) Summary | |
|---|---|
| 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. |
| 1. Submitter name, address, contact | Boehringer Mannheim Corporation |
| 2400 Bisso Lane | |
| P.O. Box 4117 | |
| Concord, CA 94524-4117 | |
| (510) 674 - 0690, extension 8413 | |
| Fax: (510) 687-1850 | |
| Contact Person: Yvette Lloyd | |
| Date Prepared: July 2, 1997 | |
| 2. Device name | Proprietary name: Tina-quant® Myoglobin Assay |
| Common name: Immunoturbidometric assay for the determination of Myoglobin. | |
| Classification name: Myoglobin immunological test system | |
| 3. Predicate device | The Boehringer Mannheim Tina-quant® Myoglobin is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Behring N Latex Myoglobin Assay. |
continued on next page
.
1
10(k) Summary, Continued
Image /page/1/Picture/1 description: The image shows a logo with the word "mannheim" written vertically on the left side of a black square. Inside the square is a white circle with the word "boehringer" written inside it. The text is in a simple, sans-serif font and the overall design is clean and minimalist.
The myoglobin determination is based upon turbidimetric immunoinhibition 4.Device (TINIA) using a serum or plasma blood sample. The sample containing f Description myoglobin is transferred into a EDTA/glycine buffer solution (R1 reagent). In the second step, an aliquot of solution containing fine latex particles coated with polyclonal anti-human myoglobin antibodies (R2 reagent) is added to mixture of the first step. The antibody-coated particles will bind to the myoglobin in the sample to form "aggregates" such that the amount of aggregate formed is proportionate to the amount of myoglobin present in the sample.
The resulting agglutination complex is measured turbidimetrically whereby increased turbidity is reflected through an increase in optical density. Therefore, the amount of myoglobin in the sample is directly proportional to the amount of turbidity formed.
2
BOEHRING BO(k) Summary, Continued ORPORATION
ﺮ
Image /page/2/Picture/1 description: The image shows a logo for Boehringer Mannheim. The logo is a black square with a white circle in the center. The word "boehringer" is written in white inside the circle. The word "mannheim" is written vertically along the left side of the square, also in white.
| 5.
| Intended use | Immunoturbidometric assay for the quantitative in-vitro determination of myoglobin. |
|---|---|
| 6. | |
| Comparison | |
| to predicate | |
| device | The Boehringer Mannheim Tina-quant® Myoglobin is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Behring N Latex Myoglobin Assay (K902154). |
The following table compares the Tina-quant® Myoglobin with the predicate device, Behring Nephlometer Myoglobin Assay. Specific data on the performance of the test have been incorporated into the draft labeling in attachment 5. Labeling for the predicate device in provided in attachment 6.
Similarities:
•Intended Use: Immunoassay for the in vitro quantitative determination of Myoglobin
•Sample type: Serum and plasma |
•Product performance
3
0(k) Summary, Continued સમાનિયા
Image /page/3/Picture/1 description: The image shows a logo for Boehringer Mannheim. The logo is black and white and features the word "boehringer" inside of a circle. The word "mannheim" is written vertically along the left side of the circle.
- Comparison to predicate device cont.
Differences:
| Feature | Tina-quant® Myoglobin | N Latex Myoglobin |
|---|---|---|
| Reaction test | ||
| principle | Spectrophotometric | |
| 570 nm | Nephlometry | |
| Instrument | ||
| required | Hitachi 911 | Nephlometer |
Performance Characteristics:
| Feature | Tina-quant® Myoglobin | N Latex Myoglobin |
|---|---|---|
| Precision | Intra-Assay Precision (ng/mL): | Modified NCCLS: |
| Within run Precision(µg/L) | ||
| Level | Control 1 Control 2 Control3 | Low Mid High |
| N | 20 20 20 | 20 20 20 |
| Mean | 32.3 71.3 471.5 | 85 160 310 |
| SD | 0.8 0.6 1.6 | 2.0 2.4 2.9 |
| %CV | 2.6 0.9 0.3 | |
| Inter-Assay Precision (ng/mL): | Day to Day Precision (µg/L): | |
| Sample 1 Sample 2 | ||
| N | 20 20 | Low Mid High |
| Mean | 71.3 471.5 | 15 15 15 |
| SD | 0.6 1.6 | 85 160 310 |
| %CV | 0.9 0.3 | 4.8 4.2 5 |
4
BOEHRING 90(k) Summary, Continued ANNHE CORPORATION
Image /page/4/Picture/1 description: The image shows the logo for Boehringer Mannheim. The logo consists of the word "boehringer" inside of a circle. To the left of the circle, the word "mannheim" is written vertically.
- Comparison to predicate device, (cont.) Performance Characteristics:
| Feature | Tina-quant® Myoglobin | N Latex Myoglobin | |
|---|---|---|---|
| Lower | |||
| Detection | |||
| Limit | 3.0 ng/mL | 25 µg/L | |
| Linearity | 3.0 - 560 ng/mL | 25.0 - 400 µg/L | |
| Method | |||
| Comparison | Vs N Latex® Myoglobin | Vs Radioimmunnoassay | |
| Myoglobin | |||
| Least Squares | Least Squares | ||
| $y=1.06x + 0.35$ | $y =0.95x-4.33$ | ||
| $r=0.989$ | |||
| $SEE=19.61$ | |||
| $N=41$ | |||
| Passing/Bablok | |||
| $y =1.07x + 3.6$ | |||
| $r=0.989$ | |||
| $SEE=13.61$ | |||
| $N=41$ |
5
BOEHRINGER10(k) Summary, Continued MANNHEIM CORPORATION
Image /page/5/Picture/1 description: The image shows a logo with the text "boehringer" inside of a circle. The circle and text are placed on a black square. The word "mannheim" is written vertically on the left side of the square. The text is white, and the background is black.
Comparison
to predicate
device, (cont.)
Performance Characteristics:
| Feature | Tina-quant® Myoglobin | N Latex Myoglobin |
|---|---|---|
| Interfering | ||
| substances | No interference at: | |
| Bilirubin | 60 mg/dL | No interference |
| Hemoglobin | 0.5 g/dL | No interference |
| Lipemia | 1500 mg/dL | No interference |
| Rheumatoid | ||
| Factor | 100 IU/mL |