(102 days)
K81340, K844423
Not Found
No
The device description details a standard immunoassay process based on chemical reactions and light detection, with results determined via a calibration curve. There is no mention of AI or ML in the device description, performance studies, or key metrics.
No
This device is an in vitro diagnostic immunoassay intended for the quantitative determination of testosterone in serum and plasma. It is used to measure the level of a substance in the body, not to treat a condition.
Yes
Explanation: The device is an immunoassay for the quantitative determination of testosterone. Quantitative determination of biomarkers like testosterone is a common diagnostic test used to aid in the diagnosis, prognosis, or monitoring of various medical conditions.
No
The device description details a complex immunoassay process involving chemical reactions, incubation steps, magnetic capture of microparticles, and chemiluminescent emission measured by a photomultiplier. This clearly indicates the use of physical hardware components and chemical reagents, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states "Immunoassay for the in vitro quantitative determination of testosterone in serum and plasma." The phrase "in vitro" is a key indicator of an IVD.
- Device Description: The description details a laboratory-based assay using biological samples (serum and plasma) and chemical reagents to measure an analyte (testosterone). This is characteristic of an IVD.
- Performance Studies: The document includes performance characteristics like precision, lower detection limit, linearity, and method comparison, which are standard evaluations for IVD devices to demonstrate their analytical performance.
- Predicate Device: The mention of a predicate device (K81340; Coat-A-Count® Total Testosterone Assay) which is also an immunoassay for testosterone, further supports that this device falls within the category of IVDs.
The entire description points to a device designed to perform tests on biological samples outside of the body to provide information for medical purposes, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Immunoassay for the in vitro quantitative determination of testosterone in serum and plasma.
Product codes
LCL
Device Description
1st incubation (9 min.): 50 µL of sample is incubated with a testosterone-specific biotinylated antibody (55uL) and a testosterone derivative labeled with a ruthenium complex (55 uL). The binding sites of the labeled antibody become occupied partly by the sample analyte (depending on its concentration) and partly by the ruthenium-labeled hapten to form the respective immunocomplexes. 2nd incubation (9 min.): After addition of streptavidin-coated microparticles (40 uL), the entire complex is bound to the solid phase via interaction of biotin and streptavidin. The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier (0.4 second read frame). Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent bar code. Tris(2,2'-bipyridyl)ruthenium(II) complex (Ru(bpy)"3)
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
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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
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Summary of Performance Studies
Precision:
Elecsys® Testosterone (Modified NCCLS (ng/mL)):
- Level Low: Within-Run (N=60, Mean=0.24, %CV=4.62), Total (N=60, Mean=0.24, %CV=7.41)
- Level Mid: Within-Run (N=60, Mean=2.75, %CV=1.39), Total (N=60, Mean=2.75, %CV=2.21)
- Level High: Within-Run (N=60, Mean=7.01, %CV=1.09), Total (N=60, Mean=7.01, %CV=1.68)
Coat-A-Count® Total Testosterone (Modified NCCLS (ng/mL)):
- Level Low: Total (N=20, Mean=0.76, %CV=11.0)
- Level Mid: Total (N=20, Mean=2.64, %CV=6.4)
- Level High: Total (N=20, Mean=6.72, %CV=6.0)
Lower Detection Limit:
- Elecsys® Testosterone: 0.02 ng/mL
- Coat-A-Count® Total Testosterone: 0.04 ng/mL
Linearity:
- Elecsys® Testosterone: 0.02-15.00 ng/mL (with a deviation from a linear line of ±10%)
- Coat-A-Count® Total Testosterone: 0.04-16.00 ng/mL (with a deviation from a linear line of ±10%)
Method Comparison:
Elecsys® Testosterone Vs RIA for Testosterone:
- Least Squares: y = 0.956x + 0.049, r = 0.963, SEE = 0.459, N = 71
- Passing/Bablok: y = 1.02 x - 0.108, r = 0.963, SEE = 0.349, N = 71
Coat-A-Count® Total Testosterone Vs RIA for Testosterone:
- Least Squares: y = 1.23x + 0.16, r = 0.987, SEE = ---, N = 83
Interfering substances:
Elecsys® Testosterone: No interference at:
- Bilirubin: 25 mg/dL
- Hemoglobin: 1.0 g/dL
- Lipemia: 1500 mg/dL
- Biotin: 30 ng/mL
Specificity:
Elecsys® Testosterone:
- 5-α-Dihydrotestosterone: Level tested (ng/mL) 40, %Cross-reactivity 1.89
- 11-Ketotestosterone: Level tested (ng/mL) 40, %Cross-reactivity 10.4
- 11-β-Hydroxytestosterone: Level tested (ng/mL) 40, %Cross-reactivity 8.34
- Ethisterone: Level tested (ng/mL) 40, %Cross-reactivity 0.02
- 5-Androstene-3β,17β-diol: Level tested (ng/mL) 40, %Cross-reactivity 0.30
- Androstenedione: Level tested (ng/mL) 40, %Cross-reactivity 0.91
- 5-α-Androstan-3β,17β-diol: Level tested (ng/mL) 40, %Cross-reactivity 0.51
- Danazol: Level tested (ng/mL) 40, %Cross-reactivity 0.00
- Norgestrel: Level tested (ng/mL) 40, %Cross-reactivity 0.00
- Estradiol: Level tested (ng/mL) 40, %Cross-reactivity 0.00
Coat-A-Count® Total Testosterone:
- 5-α-Dihydrotestosterone: Level tested (ng/mL) 50, %Cross-reactivity 3.3
- 11-Ketotestosterone: Level tested (ng/mL) 1.3, %Cross-reactivity 16
- 11-β-Hydroxytestosterone: Level tested (ng/mL) 2000, %Cross-reactivity 0.8
- Ethisterone: Level tested (ng/mL) 50, %Cross-reactivity 0.7
- 5-Androstene-3β,17β-diol: Level tested (ng/mL) 250, %Cross-reactivity 0.2
- 5-α-Androstan-3β,17β-diol: Level tested (ng/mL) 1000, %Cross-reactivity 0.04
- Danazol: Level tested (ng/mL) 200, %Cross-reactivity 0.09
- Estradiol: Level tested (ng/mL) 1000, %Cross-reactivity 0.02
Key Metrics
Not Found
Predicate Device(s)
K81340, K844423
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1680 Testosterone test system.
(a)
Identification. A testosterone test system is a device intended to measure testosterone (a male sex hormone) in serum, plasma, and urine. Measurement of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.(b)
Classification. Class I.
0
page 27
MAR 1 8 1997
510(k) Summar
According to the requirements of 21 CFR 807.92, the following information Introduction provides sufficient detail to understand the basis for a determination of substantial equivalence.
Boehringer Mannheim Corporation Submitter 2400 Bisso Lane P.O. Box 4117 address, Concord, CA 94524-4117 contact (510) 674 - 0690 extension 8413 FAX 510 687 - 1850
Contact Person: Yvette Lloyd
Date Prepared: December 5, 1996
- Device name
Common name: Electrochemiluminescence assay for the determination of testosterone .
Classification name: System, Test, Testosterone
Proprietary name: Elecsys® Testosterone Assay
- Predicate device
We claim substantial equivalence to the Coat-A-Count® Total Testosterone Assay (K81340). (K844423)
Continued on next page
Image /page/0/Picture/13 description: The image contains the words "RINGER" and "INHEIM" stacked on top of each other. The text is in a bold, sans-serif font and appears to be part of a title or heading. The background is plain and white, which makes the text stand out.
name,
Image /page/0/Picture/14 description: The image shows a logo with the text "mannheim" vertically aligned on the left side and the text "boehringer" inside a circle on the right side. The background is black, and the text and circle are white. The logo appears to be for a company or organization named "Boehringer Mannheim".
964889
1
510(k) Summary, Continued
Competition principle. Total duration of assay: 18 minutes. 4. · 1st incubation (9 min.): 50 µL of sample is incubated with a testosterone-Device specific biotinylated antibody (55uL) and a testosterone derivative labeled Description with a ruthenium complex (55 uL) ** The binding sites of the labeled antibody become occupied partly by the sample analyte (depending on its concentration) and partly by the ruthenium-labeled hapten to form the respective immunocomplexes. ·2nd incubation (9 min.): After addition of streptavidin-coated microparticles (40 uL), the entire complex is bound to the solid phase via interaction of biotin and streptavidin. ·The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier (0.4 second read frame). ·Results are determined via a calibration curve which is instrumentspecifically generated by 2-point calibration and a master curve provided via the reagent bar code. **Tris(2,2'-bipyridyl)ruthenium(II) complex (Ru(bpy)"3) Immunoassay for the in vitro quantitative determination of testosterone in પં Intended use serum and plasma. The Boehringer Mannheim Elecsys® Testosterone Assay is substantially 6. Comparison equivalent to other products in commercial distribution intended for similar to predicate use. Most notably it is substantially equivalent to the currently marketed device Coat-A-Count® Total Testosterone Assay (K81340). K844423
Continued on next page
2
510(k) Summary, Continued
- Comparison to predicate device, cont.
The following table compares the Elecsys® Testosterone Assay with the The following table compares the Enecsyson Assay . Specific data on
predicate device, Coat-A-Count® Total Testosterone Assay. Specific data on
the sevice, Coat-A-Count® Total predicate device, Coal-A-Count® Total Posts ted into the draft labeling in
the performance of the test have been in a since in attachment 6 the performance of the test have been moorporated in attachment 6.
attachment 5. Labeling for the predicate device in provided in attachment 6.
Similarities:
•Intended Use: Immunoassay for the in vitro quantitative determination of testosterone
•Sample type: Serum and plasma
| Feature | Elecsys® Testosterone | Coat-A-Count® Total Testosterone |
|---|---|---|
| Solid-Phase Binding Principal | Streptavidin/Biotin | Antibody-coated tubes |
| Reaction test principle | Electrochemiluminescence | Radioimmunoassy (RIA) |
| Instrument required | Elecsys® 2010 | Gamma counter |
| Calibration Stability | A calibration is recommended every 7 days if kit is not consumed; 4 weeks with same reagent lot if reagent is consumed within 7 days. | Calibration required every run |
Continued on next pag
3
510(k) Summary, Continued
Comparison to predicate device, cont.
Performance Characteristics:
| Feature | Elecsys®
Testosterone | | | Coat-A-Count® Total
Testosterone | | | | | | | | | |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|------------------------------------------|-------------------------------------------------------------------------------------------------------------|------------------------------------------|------|------------------------------------------|-----|--------------------------------------|-----|-------------------------------------|------|-------------------------------------|
| | Modified NCCLS
(ng/mL): | | | Modified NCCLS
(ng/mL): | | | | | | | | | |
| Precision | Level
Within-Run: N
Mean
%CV
Total: N
Mean
%CV | Low | 60
0.24
4.62
60
0.24
7.41 | Mid | 60
2.75
1.39
60
2.75
2.21 | High | 60
7.01
1.09
60
7.01
1.68 | Low | --
--
20
0.76
11.0 | Mid | --
--
20
2.64
6.4 | High | --
--
20
6.72
6.0 |
| Lower Detection Limit | 0.02 ng/mL | | | 0.04 ng/mL | | | | | | | | | |
| Linearity | 0.02-15.00 ng/mL
(with a deviation from
a linear line of ±10%) | | | 0.04-16.00 ng/mL
(with a deviation from
a linear line of ±10%) | | | | | | | | | |
| Method Comparison | Vs RIA for
Testosterone
Least Squares
$y = 0.956x + 0.049$
$r = 0.963$
$SEE = 0.459$
$N = 71$
Passing/Bablok
$y = 1.02 x - 0.108$
$r = 0.963$
$SEE = 0.349$
$N = 71$ | | | Vs RIA for
Testosterone
Least Squares
$y = 1.23x + 0.16$
$r = 0.987$
$SEE = ---$
$N = 83$ | | | | | | | | | |
Continued on next page
4
Premarket Notification, 510(k) for Elecsys® Testosterone, Continued
writed the works on and the commend to be
្រីនឹង
: : :
F.
Substantial equivalence, cont.
Performance Characteristics, cont:
| Feature | | Elecsys®
Testosterone | Coat-A-Count®
Total Testosterone | | |
|---------------------------|------------|--------------------------|-------------------------------------|-------------------------|-----------------------|
| Interfering substances | | No interference at: | No interference at: | | |
| Bilirubin | 25 mg/dL | | Not listed | | |
| Hemoglobin | 1.0 g/dL | | Not listed | | |
| Lipemia | 1500 mg/dL | | Not listed | | |
| Biotin | 30 ng/mL | | Not listed | | |
| Specificity | | Level tested
(ng/mL) | %Cross-
reactivity | Level tested
(ng/mL) | %Cross-
reactivity |
| 5-α-Dihydrotestosterone | 40 | 1.89 | 50 | 3.3 | |
| 11-Ketotestosterone | 40 | 10.4 | 1.3 | 16 | |
| 11-β-Hydroxytestosterone | 40 | 8.34 | 2000 | 0.8 | |
| Ethisterone | 40 | 0.02 | 50 | 0.7 | |
| 5-Androstene-3β,17β-diol | 40 | 0.30 | 250 | 0.2 | |
| Androstenedione | 40 | 0.91 | --- | --- | |
| 5-α-Androstan-3β,17β-diol | 40 | 0.51 | 1000 | 0.04 | |
| Danazol | 40 | 0.00 | 200 | 0.09 | |
| Norgestrel | 40 | 0.00 | --- | --- | |
| Estradiol | 40 | 0.00 | 1000 | 0.02 | |