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510(k) Data Aggregation
(366 days)
THERMO ELECTRON OY
Phenytoin is intended for in vitro diagnostic use in the quantitative determination of the phenytoin concentration in human serum on T60 analyzer. Measurements are used in the diagnosis and treatment of phenytoin overdose and in monitoring levels of phenytoin to help ensure proper therapy.
TDM Calibration set B is intended for in vitro diagnostic use as a calibrator in the quantitative measurement of the kit code 981647 Phenytoin assay on T60 Analyzer.
Not Found
The provided document describes a 510(k) submission for a Phenytoin test system and a TDM Calibration set B. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study against specific acceptance criteria. However, we can extract the reported performance of the new device and compare it to the predicate device, which can act as a proxy for acceptance criteria if the aim is to show similar performance.
Here's an analysis based on the provided text, addressing the requested information:
1. A table of acceptance criteria and the reported device performance
Since specific, pre-defined acceptance criteria are not explicitly stated as separate quantifiable thresholds in the document, I will use the predicate device's performance as the benchmark against which the new device's performance is implicitly evaluated for "substantial equivalence." The reported performance of the new device is compared directly to the predicate in "Table 1".
| Attribute | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (New Device) |
|---|---|---|
| Intended Use | For quantitation of phenytoin in human serum or plasma using automated clinical chemistry analyzers. Measurements are used in the diagnosis and treatment of phenytoin overdose and in monitoring levels to ensure proper therapy. | For in vitro diagnostic use in the quantitative determination of the phenytoin concentration in human serum on T60 analyzer. Measurements are used in the diagnosis and treatment of phenytoin overdose and in monitoring levels of phenytoin to help ensure proper therapy. |
| Indication for Use | Same as Intended Use (for predicate). | Phenytoin is intended for quantitative in-vitro diagnostic determination of the phenytoin concentration in human serum using T60 Clinical Chemistry Analyzers. Measurements are used in the diagnosis and treatment of phenytoin overdose and in monitoring levels of phenytoin to help ensure proper therapy. |
| Assay Protocol | Uses recombinant DNA technology (US Patent no. 4708929) to produce a unique homogeneous enzyme immunoassay system. | Uses recombinant DNA technology (US Patent no. 4708929) to produce a unique homogeneous enzyme immunoassay system. |
| Traceability/ Standardization | Not explicitly stated (implied to be acceptable for a legally marketed device). | The calibration values are traceable to USP reference materials prepared gravimetrically to drug-free human serum. |
| Sample Type | Serum or plasma (Na or Li heparin, Na EDTA) | Serum |
| Reagent Storage | Store CEDIA® Phenytoin II reagents at 2-8 °C. Do not freeze. Refer to box/bottle labels for expiration date. | The unopened reagents are stable at 2...8 °C until the expiration date. DO NOT FREEZE the unopened or reconstituted reagents. |
| Expected Values | Therapeutic range: 10 - 20 µg/ml for adults, 6 - 14 µg/ml for children. | Therapeutic range for adults: 10 - 20 µg/ml or 40 - 79 µmol/l (1,2) |
| Instrument | Roche Hitachi 912 | T60 and DPC T60i, DPC T60i Kusti |
| Measuring Range | Between 0.6 µg/ml and ~40 µg/ml (158.4 µmol/l). | 0.8 - 38 µg/ml (3.2 – 150 µmol/l) |
| Precision (Within run - Level 6.3/8.6 µg/ml) | SD = 0.20, CV(%) = 3.2 | SD = 0.20, CV(%) = 2.4 |
| Precision (Within run - Level 14.8/20.0 µg/ml) | SD = 0.29, CV(%) = 2.0 | SD = 0.32, CV(%) = 1.6 |
| Precision (Within run - Level 26.8 µg/ml) | SD = 0.35, CV(%) = 1.3 | N/A (new device reports only two levels) |
| Precision (Total - Level 6.3/8.6 µg/ml) | SD = 0.32, CV(%) = 5.1 | SD = 0.39, CV(%) = 4.5 |
| Precision (Total - Level 14.8/20.0 µg/ml) | SD = 0.46, CV(%) = 3.1 | SD = 0.59, CV(%) = 3.0 |
| Precision (Total - Level 26.8 µg/ml) | SD = 0.60, CV(%) = 2.3 | N/A (new device reports only two levels) |
| Method Comparison (Correlation) | $Y=1.00x -0.19$, r = 0.998, Sy.x = 0.39 | $y = 1.00x - 0.8$, r = 0.995 |
| Method Comparison (Range/N) | Range 0.7 - 35.1 µg/ml, N = 114 | Range 1.3 - 38.3 µg/ml, N = 70 |
| Limitations (Bilirubin) | No significant interference up to I index of 60 (approx. 60 mg/dl). | No interference found up to 58 mg/dl (1000 µmol/l). |
| Limitations (Hemoglobin) | No significant interference up to H index of 1000 (approx. 1000 mg/dl). | 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 Intralipid®). | No interference found up to 1000 mg/dl (10 g/l) of Intralipid®. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Method Comparison (Test Set): 70 samples (N = 70) were used for the new device's method comparison study.
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. Given the submitter's country (Finland), it's possible the data originated there, but this is not confirmed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is a quantitative diagnostic test (immunoassay), not an imaging device requiring expert interpretation. The "ground truth" for such a device is typically established by comparing its results to a well-established reference method (often the predicate device itself, or a gold standard method like mass spectrometry, though not explicitly stated as distinct from the predicate here). Therefore, the concept of "experts" establishing ground truth in the way it applies to image interpretation in radiology is not directly applicable. The predicate device's measurements serve as the comparator.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods (like 2+1 or 3+1) are relevant for studies where human expert disagreement on interpretation is resolved. This is not applicable to a quantitative immunoassay where the comparison is numerical against a reference method. Therefore, the adjudication method is none.
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
-
No, an MRMC comparative effectiveness study was not done. This type of study (MRMC, human-in-the-loop, AI assistance) is typically performed for image-based diagnostic aids or systems that augment human decision-making. The device described, a Phenytoin assay, is a standalone quantitative chemical analyzer component (reagent system) and does not involve human "readers" in the diagnostic interpretation cycle in the same way an imaging AI would.
-
Therefore, there is no effect size for human reader improvement with/without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, a standalone performance assessment was done. The performance metrics (Measuring Range, Precision, Method Comparison, Limitations) presented are characteristics of the device itself (the Phenytoin assay on the T60 analyzer) operating independently to produce a quantitative result. There is no human intervention in the result generation or interpretation to be removed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the new device's performance was established by comparison to a legally marketed predicate device (CEDIA® Phenytoin II assay). For the method comparison study, the predicate device's results were used as the reference against which the new device's results were correlated. For other performance characteristics like precision, internal validation methods would have been used.
8. The sample size for the training set
The document describes a diagnostic assay, not a machine learning or AI algorithm in the conventional sense that would require a distinct "training set." Therefore, information regarding a "training set sample size" is not applicable to this type of device.
9. How the ground truth for the training set was established
As there is no "training set" in the context of an immunoassay, the concept of establishing ground truth for it is not applicable.
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(300 days)
THERMO ELECTRON OY
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.
Not Found
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.
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(357 days)
THERMO ELECTRON OY
The Carbamazepine is intended for the quantitative in vitro diagnostic determination of the carbamazepine concentration in human serum using T60 Clinical Chemistry Analyzers. Measurements are used in the diagnosis and treatment of carbamazepine overdose and in monitoring levels of carbamazepine to help ensure proper therapy.
The Valproic Acid is intended for the quantitative in vitro diagnostic determination of the valproic acid concentration in human serum using T60 Clinical Chemistry Analyzers. Measurements are used in the diagnosis and treatment of valproic acid overdose and in monitoring levels of valproic acid to help ensure proper therapy.
TDM Calibration set B is intended for in vitro diagnostic use as a calibrator in the quantitative measurement of the kit code 981645 Carbamazepine and kit code 981650 Valproic acid assays on T60 Analyzer.
Not Found
The provided text describes the 510(k) submission for Thermo Fisher Scientific Oy's Carbamazepine and Valproic Acid test systems and TDM Calibration set B. The document outlines the intended use, indications for use, and a comparison with predicate devices to establish substantial equivalence.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria provided are primarily in comparison to a predicate device, focusing on similar performance characteristics. The document presents performance data for "New device #1" (Thermo Fisher Scientific Oy's device) and "Predicate device #1" (Microgenics Corporation CEDIA® Carbamazepine II/Valproic Acid II).
Carbamazepine Assay:
| Attribute | Acceptance Criteria (Predicate Device #1) | Reported Device Performance (New Device #1) |
|---|---|---|
| Intended Use | For quantitation of carbamazepine in human serum or plasma using automated clinical chemistry analyzers, for diagnosis and treatment of overdose and monitoring levels to ensure proper therapy. | For quantitative determination of carbamazepine concentration in human serum on T60 analyzer, for diagnosis and treatment of overdose and monitoring levels to help ensure proper therapy. |
| Indications for Use | Same as Intended Use. | For quantitative in vitro diagnostic determination of carbamazepine concentration in human serum using T60 Clinical Chemistry Analyzers, for diagnosis and treatment of overdose and monitoring levels to help ensure proper therapy. |
| Assay Protocol | Recombinant DNA technology (US Patent no. 4708929) to produce a unique homogeneous enzyme immunoassay system. | Recombinant DNA technology (US Patent no. 4708929) to produce a unique homogeneous enzyme immunoassay system. |
| Traceability/Standardization | Calibration values traceable to USP reference materials prepared gravimetrically to drug-free human serum. | Calibration values are traceable to USP reference materials prepared gravimetrically to drug-free human serum. |
| Sample Type | Serum or plasma (Na or Li heparin, Na EDTA). | Human Serum. |
| Reagent Storage | Store at 2-8 °C. Do not freeze. Stability of unopened components indicated on labels. | Unopened reagents stable at 2-8 °C until expiration date. DO NOT FREEZE. |
| Expected Values (Therapeutic Range for adults) | Ranges such as 5-12 µg/ml, 8-12 µg/ml, 3-12 µg/ml, 6-10 µg/ml, 4-10 µg/ml, 4-8 µg/ml, 4-12 µg/ml. | Suggested ranges: 4 - 12 µg/ml or 17 - 51 µmol/l (1); 4 - 10 µg/ml or 17 - 42 µmol/l (2). |
| Measuring Range | Between 0.5 µg/ml and approximately 20 µg/ml. | From 1.0 µg/ml to 19.0 µg/ml. |
| Precision | Within run: Level 4.2 µg/ml (SD=0.06, CV=1.5%), Level 10.6 µg/ml (SD=0.08, CV=0.8%), Level 16.8 µg/ml (SD=0.12, CV=0.7%). Total: Level 4.2 µg/ml (SD=0.15, CV=3.5%), Level 10.6 µg/ml (SD=0.21, CV=2.0%), Level 16.8 µg/ml (SD=0.29, CV=1.7%). | Within run: Level 3.0 µg/ml (SD=0.09, CV=2.8%), Level 9.5 µg/ml (SD=0.14, CV=1.5%), Level 15.0 µg/ml (SD=0.16, CV=1.1%). Between run: Level 3.0 µg/ml (SD=0.07, CV=2.4%), Level 15.0 µg/ml (SD=0.14, CV=0.9%). Total: Level 3.0 µg/ml (SD=0.19, CV=6.3%), Level 9.5 µg/ml (SD=0.32, CV=3.3%), Level 15.0 µg/ml (SD=0.42, CV=2.8%). |
| Method Comparison (Deming Regression) | Y = 1.04x - 0.04; r = 0.999; Sy.x = 0.26; Range 1.3 - 19.8 µg/ml; N = 103 (vs. previous CEDIA Carbamazepine assay). | y = 0.98 x + 0.02; r = 0.993; Range 1.9 - 19.6 µg/ml; N = 134. |
| Limitations (Interference) | Hemoglobin up to 1000 mg/dl, Bilirubin up to 66 mg/dl, Triglyceride up to 1000 mg/dl, Total protein up to 12 g/dl, Rheumatoid factor up to 180 IU/ml. | No interference found: Hemoglobin up to 1000 mg/dl, Bilirubin up to 58 mg/dl, Lipemia up to 1000 mg/dl of Intralipid®. |
Valproic Acid Assay:
| Attribute | Acceptance Criteria (Predicate Device #1) | Reported Device Performance (New Device #1) |
|---|---|---|
| Intended Use | For quantitation of valproic acid in human serum or plasma using automated clinical chemistry analyzers, for diagnosis and treatment of overdose and monitoring levels to ensure proper therapy. | For quantitative determination of valproic acid concentration in human serum on T60 instrument, for diagnosis and treatment of overdose and monitoring levels to help ensure proper therapy. |
| Indications for Use | Same as Intended Use. | For quantitative in vitro diagnostic determination of valproic acid concentration in human serum using T60 Clinical Chemistry Analyzers, for diagnosis and treatment of overdose and monitoring levels to help ensure proper therapy. |
| Assay Protocol | Recombinant DNA technology (US Patent no. 4708929) to produce a unique homogeneous enzyme immunoassay system. | Recombinant DNA technology (US Patent no. 4708929) to produce a unique homogeneous enzyme immunoassay system. |
| Traceability/Standardization | Calibration values traceable to USP reference materials prepared gravimetrically to drug-free human serum. | Calibration values are traceable to USP reference materials prepared gravimetrically to drug-free human serum. |
| Sample Type | Serum or plasma (Na or Li heparin, Na EDTA). | Human Serum. |
| Reagent Storage | Store at 2-8 °C. Do not freeze. Stability of unopened components indicated on labels. | Unopened reagents stable at 2-8 °C until expiration date. DO NOT FREEZE. |
| Expected Values (Therapeutic range for adults) | Ranges such as 50-100 µg/ml, 40-90 µg/ml. Toxic >100 µg/ml. | 50 - 100 µg/ml or 347 - 693 µmol/l (1,2). |
| Measuring Range | Between 3.0 µg/ml and approximately 150 µg/ml. | From 3.0 µg/ml to 142.5 µg/ml. |
| Precision | Within run: Level 24.4 µg/ml (SD=0.59, CV=2.4%), Level 95.0 µg/ml (SD=1.43, CV=1.5%), Level 136.8 µg/ml (SD=1.81, CV=1.3%). Total: Level 24.4 µg/ml (SD=0.83, CV=3.4%), Level 95.0 µg/ml (SD=1.93, CV=2.0%), Level 136.8 µg/ml (SD=2.48, CV=1.8%). | Within run: Level 35.0 µg/ml (SD=0.43, CV=1.2%), Level 81.1 µg/ml (SD=0.81, CV=1.0%), Level 113.6 µg/ml (SD=1.01, CV=0.9%). Between run: Level 35.0 µg/ml (SD=0.61, CV=1.8%), Level 81.1 µg/ml (SD=1.08, CV=1.3%), Level 113.6 µg/ml (SD=1.07, CV=0.9%). Total: Level 35.0 µg/ml (SD=1.90, CV=5.4%), Level 81.1 µg/ml (SD=3.15, CV=3.9%), Level 113.6 µg/ml (SD=3.11, CV=2.7%). |
| Method Comparison (Deming Regression) | Y = 1.08x - 0.61; r = 0.972; Sy.x = 7.042; Range 2.6 - 119.8 µg/ml; N = 77 (vs. commercially available fluorescence polarization immunoassay). | y = 0.996 x + 1.4; r = 0.993; Range 3.2 - 143.4 µg/ml; N = 136. |
| Limitations (Interference) | Hemoglobin up to 1000 mg/dl, Bilirubin up to 60 mg/dl, Triglyceride up to 1000 mg/dl, Total protein up to 10 g/dl, IgA up to 790 mg/dl, IgG up to 4300 mg/dl, IgM up to 840 mg/dl, Rheumatoid factor up to 200 IU/ml. | No interference found: Hemoglobin up to 1000 mg/dl, Bilirubin up to 58 mg/dl, Lipemia up to 1000 mg/dl of Intralipid®. |
2. Sample sizes used for the test set and the data provenance
- Carbamazepine:
- Method Comparison (test set): N = 134 samples (Carbamazepine).
- Provenance: Not explicitly stated, but clinical chemistry assays typically use de-identified human serum samples. The document doesn't specify if the data is retrospective or prospective, or the country of origin.
- Valproic Acid:
- Method Comparison (test set): N = 136 samples (Valproic Acid).
- Provenance: Not explicitly stated, but clinical chemistry assays typically use de-identified human serum samples. The document doesn't specify if the data is retrospective or prospective, or the country of origin.
- Precision (Carbamazepine & Valproic Acid): Tested at multiple levels (3 for each assay). The number of replicates or runs to achieve the reported SD and CV values is not explicitly stated in this summary but is typically part of the full validation report.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. For these types of quantitative in vitro diagnostic devices, "ground truth" is typically established by comparing the device's measurements against a recognized reference method or a predicate device that has established accuracy, rather than expert consensus on a clinical diagnosis. The predicate device's performance data is used as the comparative "truth" for demonstrating substantial equivalence.
4. Adjudication method for the test set
This is not applicable/provided as the study focuses on quantitative measurement comparison rather than diagnostic interpretation requiring adjudication. The method comparison studies for both Carbamazepine and Valproic Acid used Deming regression to compare the new device's measurements against the predicate device's measurements.
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 is not applicable. This document describes an in vitro diagnostic device (a laboratory test for drug levels) and not an imaging or interpretive AI-driven diagnostic system that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This document describes a standalone in vitro diagnostic system (reagents and an analyzer) which performs quantitative measurements of drug concentrations. The results are then used by healthcare professionals for diagnosis and treatment. In this context, the "standalone" performance refers to the analytical performance of the device itself (precision, measuring range, method comparison) as detailed in the tables. There isn't an "algorithm only" component in the sense of a software-AI device, but rather a chemical assay coupled with an automated analyzer.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the method comparison studies was the measurements obtained from the predicate devices (CEDIA® Carbamazepine II and a commercially available fluorescence polarization immunoassay for Valproic Acid). For precision studies, "truth" is established by the known concentrations of quality control materials. The overall goal is to demonstrate that the new device's measurements correlate closely with these established methods.
8. The sample size for the training set
This information is not provided in the summary. For in vitro diagnostic assays, "training set" is usually not explicitly defined in the same way as for AI/ML models. Assay development and optimization involve extensive testing with various samples, but this isn't typically presented as a distinct "training set" in 510(k) summaries for traditional IVDs.
9. How the ground truth for the training set was established
This information is not provided for the reasons mentioned in point 8.
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(275 days)
THERMO ELECTRON OY
For the in vitro quantitative determination of the Lipoprotein(a) in human serum, Liheparin plasma and EDTA plasma on T60 instruments.
Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify specific populations at risk from cardiovascular diseases
Lipoprotein(a) Calibrator is used as a calibrator for quantification of Lipoprotein(a) in serum and plasma by immunoturbidimetry with T60 instruments using methods defined by Thermo Electron Oy
For in vitro diagnostic use on T60 instrument. Lipoprotein(a) Control is intended to be used as an assayed control serum to monitor precision of Lipoprotein(a) test defined by Thermo Electron Oy
For in vitro diagnostic use on T60 instrument. Lipoprotein(a) Control High is intended to be used as an assayed control serum to monitor precision of Lipoprotein(a) test defined by Thermo Electron Oy.
Not Found
The provided text is a 510(k) premarket notification decision letter from the FDA to Thermo Electron Oy for their Lipoprotein(a) test system. This document grants market clearance for the device but does not contain the detailed study information or acceptance criteria requested.
Therefore, I cannot extract the specific information required to answer your questions about acceptance criteria, device performance, study details (sample sizes, provenance, expert qualifications, adjudication, MRMC, standalone), or ground truth establishment. This type of information is typically found within the actual 510(k) submission document, which is not provided here.
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(302 days)
THERMO ELECTRON OY
The transferrin test system is intended for the quantitative in-vitro diagnostic determination of transferrin in serum or plasma using T60 Clinical chemistry Analyzers. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, acute infection and iron deficiency anemia.
SpeciCal protein calibrator is used as a stock calibrator for both quantification of specific proteins in serum and plasma by immunoturbidimetry and for antigen excess detection using methods defined by Thermo Electron Oy
SpeciTrol is intended to be used as an assayed control serum to monitor precision of specific protein tests defined by Thermo Electron Ov
Specitrol High is intended to be used as an assayed control serum to monitor precision of specific protein tests defined by Thermo Electron Oy
Not Found
The provided text does not contain detailed information about the acceptance criteria or a study that proves the device meets those criteria. The document is primarily a 510(k) clearance letter from the FDA for a device named "Transferrin, Specical Calibrator, Specitrol Control and Specitrol High Control."
The letter confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. However, it does not include:
- A table of acceptance criteria and reported device performance.
- Information on sample sizes used for test sets, data provenance (country, retrospective/prospective).
- Details about the number or qualifications of experts used to establish ground truth.
- Adjudication methods.
- Results from a multi-reader multi-case (MRMC) comparative effectiveness study, nor the effect size of AI assistance.
- Results from a standalone algorithm-only performance study.
- The type of ground truth used (e.g., pathology, outcomes data).
- The sample size for the training set or how its ground truth was established.
The document states the intended use of the devices, which is for the quantitative in-vitro diagnostic determination of transferrin in serum or plasma using T60 Clinical Chemistry Analyzers, aiding in the diagnosis of malnutrition, acute inflammation, acute infection, and iron deficiency anemia. It also specifies the use of SpeciCal as a stock calibrator and SpeciTrol/SpeciTrol High as assayed control serums to monitor precision.
Therefore, I cannot fulfill the request for information on acceptance criteria, study details, or AI-related metrics based on the provided text.
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(149 days)
THERMO ELECTRON OY
The hemoglobin A1c (HbA1c) test system with associated calibrators and controls is intended for quantitative in-vitro diagnostic determination of the hemoglobin A1c (HbA1c) concentration as a percentage of total hemoglobin in human whole blood using T60 Clinical Chemistry Analyzers. Measurement of percent HbA1c is effective in monitoring long-term glucose control in individuals with diabetes mellitus.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called the "HbA1c Test System, Calibrator, Control normal, and Control abnormal." It primarily discusses the regulatory approval process and does not contain detailed information about the acceptance criteria and the study that proves the device meets those criteria.
Therefore, most of the requested information cannot be extracted from this document as it focuses on regulatory clearance rather than a detailed technical performance study.
Here's what can be inferred or stated based on the provided text:
- Device Name: HbA1c Test System, HbA1c Calibrators, HbA1c Control Normal, HbA1c Control Abnormal
- Intended Use: Quantitative in-vitro diagnostic determination of the hemoglobin A1c (HbA1c) concentration as a percentage of total hemoglobin in human whole blood using T60 Clinical Chemistry Analyzers. Measurement of percent HbA1c is effective in monitoring long-term glucose control in individuals with diabetes mellitus.
- Regulatory Status: Substantially equivalent to legally marketed predicate devices, Class II.
Regarding the specific questions about acceptance criteria and study details:
- A table of acceptance criteria and the reported device performance: Not provided in the document. This type of information would typically be in the 510(k) submission itself (which is not this letter) and would detail performance metrics like accuracy, precision, linearity, and analytical measurement range, along with the criteria for acceptable performance (e.g., %CV
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(154 days)
THERMO ELECTRON OY
For in vitro diagnostic use in the quantitative determination of the complement C3 concentration in human serum on the T60 analyzer.
For in vitro diagnostic use in the quantitative determination of the complement C4 concentration in human serum on the T60 analyzer.
The complement C3 and complement C4 are intended for quantative in-vitro diagnostic determination of the complement C3 and C4 concentration in human serum using T60 Clinical Chemistry Analyzers. C3 and C4 measurements may aid in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.
Not Found
The provided document describes the Thermo Electron Oy Complement C3 and C4 diagnostic test systems, along with associated calibrators (SpeciCal) and controls (SpeciTrol and SpeciTrol High). These devices are intended for the quantitative determination of complement C3 and C4 concentrations in human serum on the T60 analyzer to aid in the diagnosis of immunologic disorders.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides performance characteristics for both Complement C3 and Complement C4, comparing the new device (Thermo Electron Oy's T60 analyzer) with predicate devices (Bayer Clinical Method for ADVIA 1650). The acceptance criteria are implied by the reported performance, which demonstrates comparable results to the legally marketed predicate devices.
Complement C3 Acceptance Criteria and Performance
| Attribute | Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (New Device) |
|---|---|---|
| Intended Use | Quantitative determination of complement C3 concentration in human serum on an ADVIA® Chemistry System, aiding in diagnosis of inherited/acquired deficiencies, inflammatory, and necrotic disorders. | Quantitative determination of complement C3 concentration in human serum on the T60 analyzer, aiding in diagnosis of immunologic disorders, especially those associated with deficiencies of complement components. (Similar to predicate) |
| Assay Protocol | PEG enhanced immunoturbidimetric | PEG enhanced immunoturbidimetric (Same as predicate) |
| Traceability/ Standardization | IRMM reference Material CRM 470 from IFCC evaluated and found to recover 97% of target concentration. | Value of Complement C3 assigned using IFCC preparate CRM 470 as a primary reference. (Comparable to predicate) |
| Sample Type | Human serum | Human serum (Same as predicate) |
| Reagent Storage | Unopened reagents stable until expiration date at 2°C - 8°C, protected from light. | Reagents in unopened vials stable at 2...8 °C until expiration date. (Similar to predicate) |
| Measuring Range | 0.46 mg/dL to the C3 concentration in the Liquid Specific Protein Calibrator Level 6. | 28* – 513 mg/d* (*The values are related to the Complement C3 concentration of the calibrator and are lot dependent.) (Range covers/exceeds predicate) |
| Precision (Within run - CV%) | Level 64.02 mg/dL: 1.2% | |
| Level 124.13 mg/dL: 2.1% | ||
| Level 182.35 mg/dL: 2.1% | Level 33 mg/dL: 1.4% | |
| Level 42 mg/dL: 1.3% | ||
| Level 89 mg/dL: 0.8% | ||
| Level 216 mg/dL: 0.9% | ||
| Level 406 mg/dL: 0.8% | ||
| Level 441 mg/dL: 0.5% (Comparable or better than predicate) | ||
| Precision (Total - CV%) | Level 64.02 mg/dL: 6.5% | |
| Level 124.13 mg/dL: 7.0% | ||
| Level 182.35 mg/dL: 6.7% | Level 33 mg/dL: 3.7% | |
| Level 42 mg/dL: 3.0% | ||
| Level 89 mg/dL: 2.3% | ||
| Level 216 mg/dL: 2.4% | ||
| Level 406 mg/dL: 1.8% | ||
| Level 441 mg/dL: 2.0% (Significantly better than predicate) | ||
| Method Comparison | y = 1.06x - 6.47, r = 0.952 (for n=40 samples in range 44.6 - 250.6 mg/dL between Bayer RA Complement C3 reagent on ADVIA 1650 and predicate) | y = 0.98x + 4.99, R = 0.989 (for n=102 samples in range 28 to 299 mg/dL) (Slope closer to 1, higher R-value, broader range of samples compared to predicate's comparison method) |
| Limitations (Interference) | Bilirubin (conjugated) ≤ 25 mg/dL | |
| Bilirubin (unconjugated) ≤ 18.75 mg/dL | ||
| Hemoglobin ≤ 1000 mg/dL | ||
| Triglyceride (concentrate) ≤ 1000 mg/dL (No interference found up to these levels) | Lipemia: No interference up to 500 mg/dL (5 g/l) of Intralipid. | |
| Hemolysate: No interference up to 1000 mg/dl (10 g/l) of hemoglobin. | ||
| Bilirubin, conjugated: No interference up to 58 mg/dL (1000 µmol/l). | ||
| Bilirubin, unconjugated: No interference up to 58 mg/dl (1000 µmol/l). (Comparable or better than predicate in tested levels) |
Complement C4 Acceptance Criteria and Performance
| Attribute | Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (New Device) |
|---|---|---|
| Intended Use | Quantitative determination of complement C4 concentration in human serum on an ADVIA® Chemistry System, aiding in diagnosis of inherited/acquired deficiencies, inflammatory, and necrotic disorders. | Quantitative determination of complement C4 concentration in human serum on the T60 analyzer, aiding in diagnosis of immunologic disorders, especially those associated with deficiencies of complement components. (Similar to predicate) |
| Assay Protocol | PEG enhanced immunoturbidimetric | PEG enhanced immunoturbidimetric (Same as predicate) |
| Traceability/ Standardization | IRMM reference Material CRM-470 from IFCC evaluated and found to recover 103% of target concentration. | Value of Complement C4 assigned using IFCC preparate CRM 470 as a primary reference. (Comparable to predicate) |
| Sample Type | Human serum | Human serum (Same as predicate) |
| Reagent Stability | Unopened reagents stable until expiration date at 2°C - 8°C, protected from light. | Reagents in unopened vials stable at 2 ... 8 °C until expiration date. (Similar to predicate) |
| Measuring Range | From 0.36 mg/dL to the C3 concentration in the Liquid Specific Protein Calibrator Level 6. | 6* - 103* mg/dl (*The values are related to the Complement C4 concentration of the calibrator and are lot dependent.) (Range covers/exceeds predicate) |
| Precision (Within run - CV%) | Level 19.03 mg/dL: 1.1% | |
| Level 35.51 mg/dL: 1.6% | ||
| Level 51.70 mg/dL: 2.9% | Level 8 mg/dL: 1.3% & 1.5% | |
| Level 16 mg/dL: 1.7% | ||
| Level 46 mg/dL: 2.2% | ||
| Level 78 mg/dL: 1.0% | ||
| Level 88 mg/dL: 0.8% (Comparable or better than predicate) | ||
| Precision (Total - CV%) | Level 19.03 mg/dL: 4.0% | |
| Level 35.51 mg/dL: 5.0% | ||
| Level 51.70 mg/dL: 5.1% | Level 8 mg/dL: 2.8% & 2.7% | |
| Level 16 mg/dL: 3.5% | ||
| Level 46 mg/dL: 4.4% | ||
| Level 78 mg/dL: 1.7% | ||
| Level 88 mg/dL: 1.7% (Better than predicate) | ||
| Method Comparison | y = 0.84x + 2.33, r = 0.976 (for n=50 samples in range 10.1 – 59.1 mg/dL between Bayer RA Complement C4 reagent on ADVIA 1650 and predicate) | y = 0.99x – 0.18, R = 0.995 (for n=88 samples in range 3 to 88 mg/dl) (Slope closer to 1, higher R-value, broader range of samples compared to predicate's comparison method) |
| Limitations (Interference) | Bilirubin (conjugated) ≤18.75 mg/dL | |
| Bilirubin (unconjugated) ≤18.75 mg/dL | ||
| Hemoglobin ≤750 mg/dL | ||
| Triglyceride (concentrate) ≤1000 mg/dL (No interference found up to these levels) | Lipemia: No interference up to 300 mg/dL (3 g/l) of Intralipid®. | |
| Hemolysate: No interference up to 1000 mg/dL (10 g/l) of hemoglobin. | ||
| Bilirubin, conjugated: No interference up to 58 mg/dL (1000 µmol/l). | ||
| Bilirubin, unconjugated: No interference up to 58 mg/dL (1000 µmol/l). (Comparable or better than predicate in tested levels) |
2. Sample Sizes Used for the Test Set and Data Provenance
-
Complement C3:
- Method Comparison (Linearity/Accuracy): N = 102 samples.
- Precision: Not explicitly stated, but data is typically derived from replicate measurements of control materials or patient samples over several days/runs. The listed levels cover various concentrations (e.g., 33, 42, 89, 216, 406, 441 mg/dL).
- Interference: Specific levels of interferents (Intralipid, hemoglobin, conjugated bilirubin, unconjugated bilirubin) were tested.
- Data Provenance: Not explicitly stated, but typically these types of studies for in vitro diagnostic devices are prospective and conducted in a controlled laboratory environment. The country of origin is not mentioned.
-
Complement C4:
- Method Comparison (Linearity/Accuracy): N = 88 samples.
- Precision: Not explicitly stated, but data is typically derived from replicate measurements of control materials or patient samples over several days/runs. The listed levels cover various concentrations (e.g., 8, 16, 46, 78, 88 mg/dL).
- Interference: Specific levels of interferents (Intralipid, hemoglobin, conjugated bilirubin, unconjugated bilirubin) were tested.
- Data Provenance: Not explicitly stated, but typically these types of studies for in vitro diagnostic devices are prospective and conducted in a controlled laboratory environment. The country of origin is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. For in vitro diagnostic (IVD) devices, "ground truth" for method comparison and precision studies is typically established by comparing the new device's results to a more established, often FDA-cleared or gold standard, method (the predicate device in this case, on a different analyzer) or to known concentrations in control materials. The predicate devices are already considered to have an established "ground truth" for their measurements.
4. Adjudication Method for the Test Set
This information is not applicable or not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where subjective interpretation (e.g., radiological reads) is involved and discrepancies need to be resolved. For quantitative in vitro diagnostic assays, the comparison is made directly between numerical results from the new device and the predicate device or reference values, not through an adjudication process by experts.
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. This document describes an in vitro diagnostic (IVD) device, specifically a quantitative assay for complement proteins. It is not an AI-assisted diagnostic imaging device or a system that involves human readers interpreting data. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this type of device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is an automated chemistry analyzer (T60 analyzer) that performs quantitative measurements. The "algorithm" in this context refers to the assay's chemical reactions and measurement principles. The performance data presented (precision, linearity, method comparison, interference) reflects the standalone performance of the T60 analyzer with the specified reagents. There isn't a separate "algorithm only" component distinct from the device's operational performance that would be reported independently outside of human intervention. It is inherently a standalone analytical system.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
For these in vitro diagnostic assays, the "ground truth" for evaluating the new device's performance is established through:
- Comparison to a Predicate Device/Method: The primary method comparison studies use the Bayer Clinical Method for ADVIA 1650 Complement C3 and C4 as the reference. The assumption for substantial equivalence is that the predicate device's results are considered accurate and reliable.
- Reference Materials: For traceability and standardization, the IFCC preparate CRM 470 is used as a primary reference. This is a certified reference material with assigned values, serving as a form of "ground truth" for calibration.
- Known Concentrations: For precision and linearity studies, control materials or spiked samples with known or established concentrations are typically used.
8. The Sample Size for the Training Set
This information is not applicable/provided. The described device is a quantitative in vitro diagnostic assay, not a machine learning or AI-based system that typically uses a "training set" in the computational sense. The "development" of the assay involves optimizing reagents and protocols, and validating performance on a test set (as described above), but not a data-driven training process in the way AI models are trained.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no "training set" in the context of this IVD device.
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(95 days)
THERMO ELECTRON OY
Cystatin C is intended for quantitative in-vitro diagnostic determination of Cystatin C in human serum or Li-heparin plasma and EDTA plasma by turbidimetry using T60 Clinical Chemistry Analyzers.
Cystatin C measurements in serum and plasma are used as an aid in the diagnosis and treatment of renal diseases.
Cystatin C Calibrator is intended for in vitro diagnostic use on T60 analyzer. Cystatin C Calibrator is used as a calibrator for quantification of Cystatin C in serum and plasma by immunoturbidimetry using methods defined by Thermo Electron Oy.
Cystatin C Control is intended for in vitro diagnostic use on T60 analyzer. Cystatin C Control is used as a quality control to monitor precision of the Cystatin C test using methods defined by Thermo Electron Oy.
Cystatin C Control High is intended for in vitro diagnostic use on T60 analyzer. Cystatin C Control High is used as a quality control serum to monitor precision of the Cystatin C test using methods defined by Thermo Electron Oy.
Not Found
The provided text describes the 510(k) summary for the Thermo Electron Oy CYSTATIN C diagnostic kit. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing a specific study to meet acceptance criteria for a novel device. However, some performance characteristics are reported that can be considered as addressing acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the acceptance criteria are not explicitly stated for individual metrics. Instead, the approach is to demonstrate comparability to a legally marketed predicate device (Dako Cystatin C reagent). The document outlines several performance characteristics, and the implicit acceptance criterion is that the new device's performance should be similar or equivalent to the predicate device.
| Performance Attribute | Acceptance Criteria (Implicit - based on predicate) | Reported New Device Performance (Thermo Electron Oy CYSTATIN C) |
|---|---|---|
| Intended Use | Quantitative determination of Cystatin C in human serum, heparinized plasma, and EDTA plasma by turbidimetry and nephelometry; aid in diagnosis and treatment of renal diseases. | Quantitative determination of Cystatin C in human serum, Li-heparin plasma, and EDTA plasma on T60 analyzer; aid in diagnosis and treatment of renal diseases. |
| Assay Protocol | Particle enhanced immunoturbidimetric | Particle enhanced immunoturbidimetric |
| Traceability/Standardization | Traceability to pure recombinant Cystatin C preparation by dry mass determination. | Traceability to pure recombinant Cystatin C preparation by dry mass determination. |
| Sample Type | Human serum, heparinized plasma, EDTA plasma | Human serum, Li-heparin plasma, EDTA plasma |
| Reagent Storage | Store at 2°C - 8°C. | Store at 2°C - 8°C. |
| Expected Values | Individuals 1-50 years: 0.55-1.15 mg/L; >50 years: 0.63-1.44 mg/L | Individuals 1-50 years: 0.55-1.15 mg/L; >50 years: 0.63-1.44 mg/L |
| Measuring Range | ~0.4-7.5 mg/L | 0.44 - 7.0 mg/L |
| Precision (Within run, CV%) | Predicate provides total CV% ranges from 2.1% to 5.9% | Level 0.70 mg/L: 1.4%; Level 1.49 mg/L: 2.6%; Cystatin C Control: 2.7%; Cystatin C High Control: 1.2% |
| Precision (Between run, CV%) | Predicate provides total CV% ranges from 2.1% to 5.9% | Level 0.70 mg/L: 1.5%; Level 1.49 mg/L: 0.4%; Cystatin C Control: 3.1%; Cystatin C High Control: 0.8% |
| Precision (Total, CV%) | Predicate provides total CV% ranges from 2.1% to 5.9% | Level 0.70 mg/L: 2.3%; Level 1.49 mg/L: 2.6%; Cystatin C Control: 4.2%; Cystatin C High Control: 1.6% |
| Method Comparison (Correlation with Predicate) | High correlation (e.g., r ≥ 0.98), slope close to 1, intercept close to 0. | $y = 0.94x + 0.091$, $r = 0.9988$ (Range 0.21 to 6.58 mg/L, n = 54) |
| Interferences (Lipemia) | No interference up to 1500 mg/dL triglycerides. | No interference up to 800 mg/dL Intralipid™; No interference up to 1500 mg/dL triglycerides. |
| Interferences (Hemoglobin) | No interference up to 1000 mg/dL. | No interference up to 1000 mg/dL. |
| Interferences (Bilirubin, conjugated) | No interference up to 60 mg/dL. | No interference up to 58.5 mg/dL. |
| Interferences (Bilirubin, unconjugated) | No interference up to 60 mg/dL. | No interference up to 58.5 mg/dL. |
| Interferences (Rheumatoid factor) | No interference up to 1200 IU/mL. | No interference was found up to (value truncated in document). |
2. Sample size used for the test set and the data provenance
- Method Comparison:
n = 54samples were used for the method comparison study with the predicate device. - Precision: The sample sizes for the precision studies (within-run, between-run, total) are not explicitly stated, but results are given for specific "Levels" (e.g., 0.70 mg/L, 1.49 mg/L) and "Controls" (Cystatin C Control, Cystatin C High Control). Typically, precision studies involve running multiple replicates of these samples over several days/runs.
- Interference: No specific sample size is given for interference studies, but it's implied that studies were performed to determine the interference limits for various substances.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given the submitter's address is Finland, the studies were likely conducted there or in collaboration with Finnish institutions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. For an in vitro diagnostic device like this, "ground truth" would typically refer to the true concentration of Cystatin C in the samples. This is usually established through highly accurate reference methods or certified reference materials, not by expert consensus in the same way an imaging device might use radiologists. The document mentions traceability to "a pure recombinant Cystatin C preparation, where the Cystatin C concentration was established by dry mass determination," which serves as the ultimate reference for ground truth in this context.
4. Adjudication method for the test set
This information is not applicable/not provided. Adjudication methods (like 2+1 or 3+1) are typically used in studies involving subjective interpretation (e.g., medical imaging) where human experts determine a "ground truth" or categorize findings. For a quantitative diagnostic like Cystatin C measurement, the ground truth is established analytically (e.g., precise reference methods, dry mass determination).
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 is not applicable. The device is an in vitro diagnostic assay kit for measuring Cystatin C concentration, not an AI-assisted diagnostic tool that involves human readers or interpretation of complex, multi-case scenarios.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, this is a standalone device (algorithm only). The "algorithm" here refers to the immunoassay method itself and the T60 analyzer's processing of samples to yield a quantitative result. There is no human-in-the-loop performance component in the direct measurement process; the device outputs a quantitative value.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the Cystatin C calibrator and potentially other samples is established by traceability to a pure recombinant Cystatin C preparation, with its concentration determined by dry mass determination. This is a highly precise analytical method, serving as the "true" concentration for calibration and validation.
8. The sample size for the training set
This information is not provided. The document describes a traditional immunoassay, not a machine learning model, so the concept of a "training set" for an algorithm in the AI sense is not directly applicable. However, analytical studies for establishing assay parameters (e.g., linearity, sensitivity, specificity) would involve a range of samples and controls, but these are not explicitly termed a "training set" here.
9. How the ground truth for the training set was established
As noted above, a "training set" in the AI sense is not directly applicable. However, the ground truth for calibrators and control materials used in developing and validating the assay would be established through traceability to pure recombinant Cystatin C preparation with concentration determined by dry mass determination, as mentioned for the overall assay's standardization.
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(110 days)
THERMO ELECTRON OY
The DPC T60i and DPC T60i Kusti Clinical Chemistry Analyzers are fully automated random access analyzers for in-vitro diagnostic use with clinical laboratory assays validated for use on these instrument platforms, including an ISE unit with Na+, K+ and CI- electrodes.
The DPC T60 Glucose (HK) test system with associated Calibrators and Controls is intended for quantitative in-vitro diagnostic determination of glucose in serum or plasma using the DPC T60i and DPC T60i Kusti Clinical Chemistry Analyzers. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoqlycemia, and of pancreatic islet cell carcinoma.
The DPC ISE Micro Volume Chloride, Potassium and Sodium Electrodes with associated Calibrators are intended for quantitative in-vitro diagnostic determination of Chloride, Potassium and Sodium in serum or plasma using the DPC T60i and DPC T60i Kusti Clinical Chemistry Analyzers.
Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders.
Potassium measurements monitor electrolyte balance and in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.
Sodium measurements are used in the diagnosis and treatment diseases involving electrolyte imbalance.
The DPC T60i and DPC T60i Kusti Clinical Chemistry Analyzers are fully automated random access analyzers for in-vitro diagnostic use with clinical laboratory assays validated for use on these instrument platforms, including an ISE unit with Na+, K+ and CI- electrodes.
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a clinical chemistry analyzer. It does not contain any information about acceptance criteria or a study proving device performance as requested in your prompt.
Specifically, the document:
- Identifies the device (DPC T60i and DPC T60i Kusti Clinical Chemistry Analyzer and associated assays).
- States its intended use (in-vitro diagnostic determination of glucose, chloride, potassium, and sodium in serum or plasma).
- Declares substantial equivalence to a predicate device.
- Outlines general regulatory requirements.
It does not include:
- A table of acceptance criteria and reported device performance.
- Details about sample sizes, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, types of ground truth, or information about training sets.
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