(102 days)
Immunoassay for the in vitro quantitative determination of testosterone in serum and plasma.
Competition principle. Total duration of assay: 18 minutes.
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.
The provided text describes the Elecsys® Testosterone Assay and compares its performance characteristics to a predicate device, the Coat-A-Count® Total Testosterone Assay. The information focuses on analytical performance criteria rather than a clinical study with human readers or ground truth established by experts.
Here's an analysis based on your requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" but rather presents "Performance Characteristics" for the Elecsys® Testosterone Assay. I will interpret the reported values as the device's performance against implicit industry standards or those set by the predicate device.
| Feature | Acceptance Criteria (Implied) | Reported Device Performance (Elecsys® Testosterone) |
|---|---|---|
| Precision | Comparable to predicate and within acceptable analytical variation | Within-Run %CV: Low: 4.62%, Mid: 1.39%, High: 1.09%Total %CV: Low: 7.41%, Mid: 2.21%, High: 1.68% |
| Lower Detection Limit | As low or lower than predicate device, clinically relevant | 0.02 ng/mL |
| Linearity | Clinically useful range with minimal deviation | 0.02-15.00 ng/mL (with a deviation from a linear line of ±10%) |
| Method Comparison (vs. RIA) | Strong correlation (high 'r' value), low SEE, and a slope/intercept close to 1/0, respectively | Least Squares: y = 0.956x + 0.049, r = 0.963, SEE = 0.459, N = 71Passing/Bablok: y = 1.02x - 0.108, r = 0.963, SEE = 0.349, N = 71 |
| Interfering Substances | No significant interference at specified concentrations for common interferents | No interference at: Bilirubin 25 mg/dL, Hemoglobin 1.0 g/dL, Lipemia 1500 mg/dL, Biotin 30 ng/mL |
| Specificity (%Cross-reactivity) | Low cross-reactivity for structurally similar compounds | Varied, with some compounds showing higher cross-reactivity than others (e.g., 11-Ketotestosterone 10.4%, but many others much lower) |
2. Sample size used for the test set and the data provenance
The document does not explicitly define a "test set" in the context of a clinical study. The sample sizes reported are for the analytical performance characteristics:
- Precision: N=60 for each level (low, mid, high) for both within-run and total precision.
- Method Comparison: N=71 for the comparison against RIA.
The provenance of this data (e.g., country of origin, retrospective/prospective) is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The device is an immunoassay for quantitative determination of testosterone, and its performance is evaluated through analytical methods (precision, linearity, method comparison with a reference method) rather than through a ground truth established by human experts interpreting results.
4. Adjudication method for the test set
This information is not applicable for this type of analytical device performance study.
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
This information is not applicable. The device is an automated immunoassay, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The described performance is inherent to the standalone device (the Elecsys® Testosterone Assay) because it is an automated immunoassay system. There is no human-in-the-loop performance component being evaluated in the reported studies, as it is a quantitative measurement device.
7. The type of ground truth used
The "ground truth" for the method comparison was a reference method, specifically RIA (Radioimmunoassay) for Testosterone. The performance characteristics such as precision and linearity are assessed against the device's own measurements and known standards.
8. The sample size for the training set
The document does not describe a "training set" in the context of machine learning or AI. The term "training set" is not relevant to an immunoassay like the Elecsys® Testosterone Assay.
9. How the ground truth for the training set was established
This information is not applicable.
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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".
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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
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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 |
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510(k) Summary, Continued
Comparison to predicate device, cont.
Performance Characteristics:
| Feature | Elecsys®Testosterone | Coat-A-Count® TotalTestosterone | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Modified NCCLS(ng/mL): | Modified NCCLS(ng/mL): | ||||||||||||
| Precision | LevelWithin-Run: NMean%CVTotal: NMean%CV | Low | 600.244.62600.247.41 | Mid | 602.751.39602.752.21 | High | 607.011.09607.011.68 | Low | ------200.7611.0 | Mid | ------202.646.4 | High | ------206.726.0 |
| Lower Detection Limit | 0.02 ng/mL | 0.04 ng/mL | |||||||||||
| Linearity | 0.02-15.00 ng/mL(with a deviation froma linear line of ±10%) | 0.04-16.00 ng/mL(with a deviation froma linear line of ±10%) | |||||||||||
| Method Comparison | Vs RIA forTestosteroneLeast 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 forTestosteroneLeast Squares$y = 1.23x + 0.16$$r = 0.987$$SEE = ---$$N = 83$ |
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Premarket Notification, 510(k) for Elecsys® Testosterone, Continued
writed the works on and the commend to be
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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 |
§ 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.