(300 days)
Lithium is intended for in vitro diagnostic use in the quantitative determination of the lithium concentration in human serum on T60 Clinical Chemistry Analyzers. Measurements are used as an aid in the management of individuals taking lithium for the treatment of mental disturbances, such as manic-depressive illness (bipolar disorder).
Theophylline is intended for quantitative in vitro diagnostic determination of the theophylline concentration in human serum using T60 Clinical Chemistry Analyzers. Measurements are used in the diagnosis and treatment of theophylline overdose and in monitoring levels of theophylline to help ensure proper therapy.
The ISE Calibrators 1 and 2 & 3 are intended for calibration of ion selective electrodes for quantitative measurements of potassium, sodium and chloride in human serum or plasma and lithium in human serum. For the in vitro diagnostic use on the T60 analyzer.
TDM Calibration set B is intended for in vitro diagnostic use as a calibrator in the quantitative measurement of the kit code 981649 Theophylline assay on T60 Analyzer.
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The provided document describes the acceptance criteria and study results for two devices: the Lithium Micro Volume Electrode and Theophylline. Both are in vitro diagnostic devices for quantitative determination in human serum on T60 Clinical Chemistry Analyzers.
Here's a breakdown of the requested information for each device:
Lithium Micro Volume Electrode
1. Table of Acceptance Criteria and Reported Device Performance
The document compares the new device with a predicate device (Infinity™ Lithium Reagent for Olympus®). Performance metrics are presented for both devices, allowing for implicit comparison rather than explicit acceptance criteria.
| Attribute | Acceptance Criteria (New Device) - Implied from Predicate | Reported Device Performance (New Device) |
|---|---|---|
| Intended Use | Quantitative determination of lithium concentration in human serum. | For in vitro diagnostic use in the quantitative determination of the lithium concentration in human serum on T60 analyzer. |
| Indication for Use | Aid in management of individuals taking lithium for mental disturbances. | Aid in the management of individuals taking lithium for the treatment of mental disturbances, such as manic-depressive illness (bipolar disorder). |
| Assay Protocol | (Predicate: Spectrophotometric) | Potentiometric |
| Traceability/Standardization | (Predicate: Not specified) | NIST SRM 924 |
| Sample Type | Serum | Serum |
| Measuring Range | Similar to predicate (0.04 - 3.00 mmol/l) | 0.2 - 4.0 mmol/l |
| Precision (Within run) | Level 0.57 mmol/l: CV(%) = 0.9; Level 1.83 mmol/l: CV(%) = 0.7 (predicate) | Level 0.95 mmol/l: SD = 0.008, CV(%) = 0.9; Level 1.86 mmol/l: SD = 0.017, CV(%) = 0.9 |
| Precision (Between run) | (No explicit predicate for between-run provided) | Level 0.95 mmol/l: SD = 0.009, CV(%) = 0.9; Level 1.86 mmol/l: SD = 0.009, CV(%) = 0.5 |
| Precision (Total) | Level 0.57 mmol/l: CV(%) = 1.9; Level 1.83 mmol/l: CV(%) = 1.3 (predicate) | Level 0.95 mmol/l: SD = 0.020, CV(%) = 2.1; Level 1.86 mmol/l: SD = 0.039, CV(%) = 2.1 |
| Method Comparison (Correlation) | r = 0.9956 (predicate) | r = 0.999 |
| Method Comparison (Equation) | y = 1.01x - 0.007 (predicate) | y = 0.98x - 0.01 |
| Method Comparison (Range) | 0.11 - 1.73 mmol/l (predicate) | 0.25 - 4.09 mmol/l |
| Limitations (Bilirubin) | No significant interference up to 45 mg/dl (predicate) | No interference found up to 41 mg/dl (700 µmol/l) of conjugated Bilirubin |
| Limitations (Lipemia) | No significant interference up to 22.6 mmol/l (2000 mg/dl) (predicate) | No interference found up to 1000 mg/dl (10 g/l) of Intralipid® |
| Limitations (Hemolysate/Hemoglobin) | No interference up to 2 g/l (predicate) | No interference found up to 1000 mg/dl (10 g/l) of hemoglobin |
2. Sample size used for the test set and the data provenance
- Sample Size: N = 117 samples were used for the method comparison study.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, given it's a 510(k) submission, it's typically clinical samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device performs quantitative chemical analysis, where instrument readings and reference methods (predicate device for comparison) establish the ground truth, not human experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for quantitative chemical analysis. Ground truth is established by the reference method (predicate device in this case), not by expert adjudication.
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
Not applicable. This is a standalone diagnostic device for chemical analysis, 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
Yes, the device (Lithium Micro Volume Electrode) is a standalone diagnostic tool. Its performance is measured directly against a predicate device and established analytical parameters like precision.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the test set was established by a predicate device (NOVA ISE), which is a legally marketed device for lithium measurement. The method comparison data shows correlation against this established method.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
Theophylline
1. Table of Acceptance Criteria and Reported Device Performance
The document compares the new device with a predicate device (The CEDIA® Theophylline II Assay). Performance metrics are presented for both devices for implicit comparison rather than explicit acceptance criteria.
| Attribute | Acceptance Criteria (New Device) - Implied from Predicate | Reported Device Performance (New Device) |
|---|---|---|
| Intended Use | Quantitative determination of theophylline concentration in human serum for diagnosis and treatment of overdose and therapy monitoring. | For in vitro diagnostic use in the quantitative determination of the theophylline concentration in human serum on T60 analyzer. Measurements are used in the diagnosis and treatment of theophylline overdose and in monitoring levels of theophylline to help ensure proper therapy. |
| Indication for Use | Same as intended use. | Same as intended use. |
| Assay Protocol | Homogeneous enzyme immunoassay using recombinant DNA technology. | Assay uses recombinant DNA technology (US Patent no. 4708929) to produce a unique homogeneous enzyme immunoassay system. |
| Traceability/Standardization | (Predicate: Not specified) | The calibration values are traceable to USP reference materials prepared gravimetrically to drug-free human serum. |
| Sample Type | Serum | Serum |
| Measuring Range | Between 0.8 µg/ml and approx. 40 µg/ml (predicate) | From 1.4 µg/ml or 7.8 µmol/l to 40 µg/ml or 222 µmol/l. |
| Precision (Within run) | Level 5.1 µg/ml: CV(%) = 3.3; Level 15.1 µg/ml: CV(%) = 1.9; Level 29.3 µg/ml: CV(%) = 1.3 (predicate) | Level 4.4 µg/ml: SD = 0.17, CV(%) = 3.9; Level 13.8 µg/ml: SD = 0.21, CV(%) = 1.5; Level 28.1 µg/ml: SD = 0.21, CV(%) = 0.8 |
| Precision (Total) | Level 5.1 µg/ml: CV(%) = 5.1; Level 15.1 µg/ml: CV(%) = 2.4; Level 29.3 µg/ml: CV(%) = 2.0 (predicate) | Level 4.4 µg/ml: SD = 0.35, CV(%) = 8.0; Level 13.8 µg/ml: SD = 0.59, CV(%) = 4.3; Level 28.1 µg/ml: SD = 0.87, CV(%) = 3.1 |
| Method Comparison (Correlation) | r = 0.997 (predicate) | r = 0.998 |
| Method Comparison (Equation) | y = 1.01x - 0.41 (predicate) | y = 0.989x + 0.05 |
| Method Comparison (Range) | 0.9 - 37.4 µg/ml (predicate) | 1.1 - 37.7 µg/ml |
| Limitations (Bilirubin) | No significant interference up to 66 mg/dl (predicate) | No interference found up to 58 mg/dl (1000 µmol/l) |
| Limitations (Hemoglobin) | No significant interference up to 1000 mg/dl (predicate) | No interference found up to 1000 mg/dl (10 g/l) |
| Limitations (Lipemia) | No significant interference up to L index of 1000 (approx. 2000 mg/dl triglycerides) (predicate) | No interference found up to 1000 mg/dl (10 g/l) of Intralipid® |
| Limitations (Uremic patients) | Should not be used due to cross-reactivity with 1,3-Dimethyluric Acid (predicate) | Due to cross-reactivity with 1,3-Dimethyluric Acid, the Theophylline assay should not be used to quantitate samples from uremic patients. |
2. Sample size used for the test set and the data provenance
- Sample Size: N = 133 samples were used for the method comparison study.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, as a 510(k) submission, it typically involves clinical samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device performs quantitative chemical analysis, where instrument readings and reference methods (predicate device for comparison) establish the ground truth, not human experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for quantitative chemical analysis. Ground truth is established by the reference method (predicate device in this case), not by expert adjudication.
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
Not applicable. This is a standalone diagnostic device for chemical analysis, 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
Yes, the device (Theophylline) is a standalone diagnostic tool. Its performance is measured directly against a predicate device and established analytical parameters like precision.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the test set was established by a commercially available fluorescence polarization immunoassay (the predicate device). The method comparison data shows correlation against this established method.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 862.3560 Lithium test system.
(a)
Identification. A lithium test system is a device intended to measure lithium (from the drug lithium carbonate) in serum or plasma. Measurements of lithium are used to assure that the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder).(b)
Classification. Class II.