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510(k) Data Aggregation
(266 days)
K243462**
Trade/Device Name: Diazyme Colorimetric Lithium Assay
Regulation Number: 21 CFR 862.3560
Diazyme Colorimetric Lithium Assay kit is for quantitative in vitro determination of lithium in human serum or EDTA plasma. Measurements of lithium are carried out to ensure that proper drug dosage is administered in the treatment of patient suffering from bipolar disorder and to avoid toxicity.
Not Found
This document is an FDA 510(k) clearance letter for the Diazyme Colorimetric Lithium Assay. It formally grants permission to market the device based on a determination of substantial equivalence to predicate devices. However, this document does not contain the detailed study information regarding acceptance criteria and performance data.
The letter primarily covers:
- Confirmation of 510(k) review and clearance.
- The trade/device name, regulation number/name, regulatory class, and product code.
- General controls and additional regulations applicable to the device (e.g., Quality System regulation, UDI rule, MDR).
- Contact information for FDA resources.
- The "Indications for Use" statement for the device.
To answer your specific questions, one would typically need access to the 510(k) submission document itself, specifically the performance data sections. The provided FDA letter is the clearance notice, not the supporting technical file.
Therefore, I cannot provide the information requested in your prompt based solely on the provided FDA clearance letter. The letter confirms that a review was done and clearance granted, implying that the device did meet acceptance criteria demonstrated in the submission, but it does not detail those criteria or the study results.
To answer your questions, I would need a different document, such as the actual 510(k) application's test report or a summary of safety and effectiveness data (SSE) that outlines the performance studies.
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(212 days)
| Class II | JFP |
| Lithium Test System | 862.3560
The SmartLyte® Plus is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, potassium, chloride, calcium and lithium in Serum, Sodium Heparin Plasma, and Venous Whole Blood, as well as measurement of sodium, potassium and chloride in pre-diluted Urine samples.
The SmartLyte® Plus Sodium Assay is intended to measure sodium in Venous Whole Blood, Serum, Sodium Heparin Plasma, and Urine on the SmartLyte® Plus Electrolyte Analyzer. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute Urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.
The SmartLyte® Plus Potassum Assay is intended to measure potassium in Venous Whole Blood, Serum, Sodium Heparin Plasma, and Urine on the SmartLyte® Plus Electrolyte Analyzer. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.
The SmartLyte® Plus Chloride Assay is intended to measure the level of chloride in Venous Whole Blood, Serum, Sodium Heparin Plasma, and Urine on the SmartLyte® Plus Electrolyte Analyzer. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The SmartLyte® Plus Calcium Assay is intended to measure ionized calcium levels in Venous Whole Blood, Sodium Heparin Plasma, and Serum on the SmartLyte® Plus Electrolyte Analyzer. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
The SmartLyte® Plus Lithium Assay is intended to measure lithium carbonate) in Venous Whole Blood, Sodium Heparin Plasma, and Serum on the SmartLyte® Plus Electrolyte Analyzer. Measurements of ithium are used to assure that the proper drug dosage is administered in the treatment with mental disturbances, such as manic-depressive illness (bipolar disorder).
For in-vitro diagnostic use only.
The SmartLyte® Plus Na+, K+, Cl-, Ca++, Li+ Electrolyte Analyzer which can test Serum, Sodium Heparin Plasma, Venous Whole Blood, pre-diluted Urine samples, and QC materials is substantially equivalent to it's predicate SmartLyte® Na+, K+, Cl-, Ca++, Li+ Electrolyte Analyzer which tests Serum, Sodium Heparin Plasma, Venous Whole Blood, pre-diluted Urine samples, and QC materials. Both are microprocessor-controlled analyzers which utilize ion-selective electrodes for the measurement of Sodium, Potassium, Chloride, Calcium and Lithium in Serum, Sodium Heparin Plasma, Venous Whole Blood, pre-diluted Urine samples, and QC materials. The analyzer self-calibrates using Diamond Diagnostics Fluid Pack (510(k) 013850) every 4 hours throughout the day or on request. Sodium. Potassium. Chloride and Calcium are commonly measured for use in the diagnosis and management of patients with a broad range of renal, metabolic and cardiovascular disorders. Lithium is a drug used to treat mental illness. Mission controls (510 (k) 033063) are the recommended quality control material to be used daily.
The SmartLyte® Plus is intended to be a direct replacement for the SmartLyte® Electrolyte Analyzer (K082462).
The SmartLyte® Plus Electrolyte Analyzer is designed for clinical laboratory professionals to assess the levels of Sodium, Potassium, Chloride, Calcium and Lithium found in Venous Whole Blood, Sodium Heparin Plasma, Serum, and Urine of patients. The analysis is performed in-vitro, and neither the analyzer nor any of its components come in contact with the patient.
The document describes the performance of the SmartLyte® Plus Electrolyte Analyzer. This device is an in-vitro diagnostic instrument, and the provided information details its analytical performance characteristics rather than the performance of an AI algorithm with human readers or a medical imaging device. Therefore, many of the requested points related to AI, MRMC studies, human experts, and ground truth establishment for complex data like images are not directly applicable or available in this document.
However, I can extract and present the acceptance criteria and reported device performance for the SmartLyte® Plus Electrolyte Analyzer as it relates to its analytical accuracy and precision.
Here's an analysis based on the provided document:
Acceptance Criteria and Reported Device Performance
The document presents performance data for Precision and Linearity for each analyte (Na+, K+, Cl-, Ca++, Li+) across different sample types (Serum, Plasma, Whole Blood, Urine). The acceptance criteria are implicitly quantitative, as the 'Status' for each test is reported as "Pass" against numerical criteria.
1. Table of Acceptance Criteria and Reported Device Performance (Summary)
Since the document provides extensive tables for precision (within-run and run-to-run) and linearity for each analyte and matrix, I will summarize the general acceptance criteria and indicate that the device passed all these criteria as reported in the document. Presenting every single data point for all analytes and matrices would be too large for this format.
Precision (for Serum/Blood/Plasma)
| Analyte | Within Run Criterion (CV or SD) | Between Run Criterion (CV or SD) | Device Performance (Status) |
|---|---|---|---|
| Na+ | CV ≤ 1% | CV ≤ 2% | Pass |
| K+ | CV ≤ 1.5% | CV ≤ 3% | Pass |
| Cl- | CV ≤ 1% | CV ≤ 3% | Pass |
| Ca++ | SD ≤ 0.02 | SD ≤ 0.06 | Pass |
| Li+ | SD ≤ 0.03 | SD ≤ 0.09 | Pass |
Precision (for Urine)
| Analyte | Within Run Criterion (CV) | Between Run Criterion (CV) | Device Performance (Status) |
|---|---|---|---|
| Na+ | CV ≤ 5% | CV ≤ 5% | Pass |
| K+ | CV ≤ 5% | CV ≤ 5% | Pass |
| Cl- | CV ≤ 5% | CV ≤ 5% | Pass |
Linearity (General Acceptance Criterion)
| Performance Metric | Implicit Acceptance Criteria | Device Performance (Status) |
|---|---|---|
| Slope | Near 1.0 (actual ranges provided in tables are typically 0.97 to 1.03) | Achieved (Values reported) |
| Intercept | Near 0.0 (actual values reported) | Achieved (Values reported) |
| R² (Coefficient of Determination) | High value, typically > 0.99 (actual values reported are 0.9939 to 0.9997, indicating strong linear correlation) | Achieved (Values reported) |
| Reportable Range | The linearity studies supported the claimed measurement ranges for each analyte and matrix. | Supported |
Detection Limit
| Analyte | Acceptance Criteria for %TE | Claimed Measurement Range | Device Performance (%TE) | Device Performance (Status) |
|---|---|---|---|---|
| Ca++ | 21.6% | 0.3 - 5.0 mmol/L | 5.541% - 11.868% | Pass (LoQ |
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(147 days)
|
| Calcium Test System | 862.1145 | Class II | JFP |
| Lithium Test System | 862.3560
The SMARTLYTE is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, potassium, chloride, calcium and lithium in serum, plasma, whole blood, pre-diluted urine samples. In addition, the analyzer can also measure sodium, chloride and calcium in dialysate samples.
The SMARTLYTE Sodium Assay is intended to measure sodium in whole blood, serum, plasma, pre-diluted urine and dialysate on the SMARTLYTE Electrolyte Analyzer. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.
The SMARTLYTE Potassium Assay is intended to measure potassium in whole blood, serum, plasma, urine and dialysate. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.
The SMARTLYTE Chloride Assay is intended to measure the level of chloride in whole blood, serum, plasma, urine and dialysate. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The SMARTLYTE Calcium Assay is intended to measure ionized calcium levels in whole blood, plasma, serum, and dialysate. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
The SMARTLYTE Lithium Assay is intended to measure lithium (from the drug lithium carbonate) in whole blood, plasma, and serum. 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).
The SMARTLYTE Nat, K", CT, Ca*, Li Electrolyte Analyzer which can test serum, plasma, whole blood, pre-diluted urine samples, dialysate solutions and QC materials is identical to GEMLYTE Electrolyte Analyzer ( cleared under K082462) which tests serum, plasma, whole blood, pre-diluted urine samples, and QC materials. Both are microprocessor-controlled analyzers which utilize ion-selective electrodes for the measurement of sodium, potassium, chloride, calcium and lithium in serum, plasma, whole blood, pre-diluted urine samples, dialysate solutions and QC materials. The analyzer self-calibrates using Diamond Diagnostics Fluid Pack (510(k) 013850) every 4 hours through out the day or on request. Sodium, potassium, chloride and calcium are commonly measured for use in the diagnosis and management of patients with a broad range of renal, metabolic and cardiovascular disorders. Lithium is a drug used to treat mental illness. Mission controls (510 (k) 033063) are the recommended . quality control material to be used daily.
Here's an analysis of the provided text, outlining the acceptance criteria and the study that proves the device meets them, based on your requested format:
Acceptance Criteria and Device Performance Study for SMARTLYTE Electrolyte Analyzer
The SMARTLYTE Electrolyte Analyzer is an automated, microprocessor-controlled device using ion-selective electrodes to measure sodium, potassium, chloride, calcium, and lithium in various sample types, including dialysate. The study aimed to demonstrate the substantial equivalence of the SMARTLYTE to its predicate device, the AVL 9180 (K961458), particularly for dialysate measurements, which represent a modification from previously cleared uses.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally implied by the predicate device's performance characteristics or defined in the "Reproducibility" section as maximum allowable CVs or SDs. The reported device performance is from the "Precision Dialysate" and "Dialysate Comparison" sections.
Note on Acceptance Criteria: The document primarily compares the SMARTLYTE's performance to the predicate device's expected values and establishes its own internal precision targets. For the method comparison, "good correlation to predicate with correlation coefficients typically greater than 0.99 and slope values between 0.96 and 1.04" serves as a key acceptance criterion for the clinical claims (correlation with a predicate device). For precision, specific CV/SD targets are given.
| Parameters | Matrix | Acceptance Criteria (Predicate/Target) | Reported Device Performance (SMARTLYTE) |
|---|---|---|---|
| Precision | |||
| Na+ | Dialysate | Within Run C.V. ≤ 1% | |
| Between Run C.V. ≤ 2% | Within Run C.V.: 0.32-0.47% | ||
| Between Run C.V.: 0.32-0.54% | |||
| K+ | Dialysate | Within Run C.V. ≤ 2% | |
| Between Run C.V. ≤ 3% | Within Run C.V.: 0.28-0.87% | ||
| Between Run C.V.: 0.88-1.27% | |||
| Cl- | Dialysate | Within Run C.V. ≤ 2% | |
| Between Run C.V. ≤ 3% | Within Run C.V.: 0.24-0.89% | ||
| Between Run C.V.: 0.53-1.44% | |||
| Ca++ | Dialysate | Within Run SD ≤ 0.02 | |
| Between Run SD ≤ 0.06 | Within Run SD: 0.0087-0.0155 (CV not calculated in source) | ||
| Between Run SD: 0.0076-0.0226 (CV not calculated in source) | |||
| Na+ | Urine | Within Run C.V. ≤ 5% | |
| Between Run C.V. ≤ 5% (Predicate: ≤ 7%) | (Not explicitly reported in this document for Urine; previously cleared K082462) | ||
| K+ | Urine | Within Run C.V. ≤ 5% | |
| Between Run C.V. ≤ 5% | (Not explicitly reported in this document for Urine; previously cleared K082462) | ||
| Cl- | Urine | Within Run C.V. ≤ 5% | |
| Between Run C.V. ≤ 5% | (Not explicitly reported in this document for Urine; previously cleared K082462) | ||
| Linearity | Dialysate | R-squared ≈ 0.99 (implied by "good correlation") | Sodium: 0.9995 |
| Potassium: 0.9976 | |||
| Chloride: 0.9998 | |||
| Calcium: 0.9972 | |||
| Slope ≈ 1 (implied) | Sodium: 0.9806 | ||
| Potassium: 1.0031 | |||
| Chloride: 0.9996 | |||
| Calcium: 0.9857 | |||
| Intercept ≈ 0 (implied) | Sodium: 2.53 | ||
| Potassium: -0.37 | |||
| Chloride: 1.60 | |||
| Calcium: 0.06 | |||
| Method Comparison (to predicate AVL 9180) | Dialysate | R > 0.99, Slope 0.96-1.04 (Stated by manufacturer) | Sodium: R=0.9989, Slope=1.0183 |
| Potassium: R=0.9996, Slope=0.9882 | |||
| Chloride: R=0.9966, Slope=0.9825 | |||
| Calcium: R=0.9956, Slope=1.0021 | |||
| Measuring Range | Dialysate | Na: 40-205 mEq/L | |
| K: 1.7-15 mEq/L | |||
| Cl: 50-200 mEq/L | |||
| Ca: 0.3-5.5 mmol/L (Predicate range) | Na: 40-200 mEq/L (Linearity confirmed: 24-205); Method comparison supported: 40-205 mEq/L | ||
| K: 1.7-15 mEq/L (Linearity confirmed: 1.4-15.1); Method comparison supported: 1.7-11 mEq/L | |||
| Cl: 50-200 mEq/L (Linearity confirmed: 40-202); Method comparison supported: 50-205 mEq/L | |||
| Ca: 0.3-5.5 mmol/L (Linearity confirmed: 0.4-5.0); Method comparison supported: 0.3-5.5 mmol/L |
2. Sample Size Used for the Test Set and Data Provenance
- Precision (Dialysate):
- Within-run: 30 replicates for each of three dialysate samples (low, mid, high concentrations) per measurand.
- Between-run (Total precision): 40 replicates (4 groups of 10 replicates over 10 days) for each of three dialysate samples per measurand.
- Linearity (Dialysate):
- Sodium: 34 samples
- Potassium: 36 samples
- Chloride: 34 samples
- Calcium: 48 samples
- Method Comparison (Dialysate):
- Sodium: 43 samples
- Potassium: 56 samples
- Chloride: 51 samples
- Calcium: 43 samples
Data Provenance: The document implies these were prospective studies conducted to support the 510(k) submission for the specific device modifications. No explicit country of origin is stated for data collection, but given it's a US FDA submission, it's typically assumed to be North American or adhering to international standards accepted by the FDA. The samples were "dialysates collected" and some were "spiked or diluted" to span the measurement ranges, suggesting a mix of clinical and artificially prepared samples. Prior data for whole blood, serum, plasma, and urine were "previously cleared (K082462)".
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This is an in-vitro diagnostic device measuring analytes. The "ground truth" for the test set is established by the reference methods or the predicate device that the SMARTLYTE is compared against, not by human expert assessment of images or clinical cases. The reference for comparison would be the AVL 9180 predicate device.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1 for consensus among experts) are used in studies involving human interpretation or subjective assessments. This study evaluates the analytical performance of an IVD device against a predicate or defined analytical targets.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study involves multiple human readers evaluating cases with and without AI assistance to measure a change in human performance (e.g., diagnostic accuracy, reading time). The SMARTLYTE is an automated IVD device; it does not involve human readers interpreting output in the same way an imaging AI would.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the studies described (precision, linearity, method comparison) represent standalone performance of the SMARTLYTE device. The device operates automatically to measure analyte concentrations. The "human-in-the-loop" aspect is limited to operating the device and collecting samples, not interpreting an AI's output to make a diagnosis.
7. The Type of Ground Truth Used
The "ground truth" for the performance studies can be defined as:
- Reference Intervals/Expected Values: For linearity studies, expected values based on known dilutions of stock solutions serve as the ground truth.
- Predicate Device Measurements: For the method comparison study, the measurements from the predicate device (AVL 9180) on the same dialysate samples served as the comparative ground truth.
- Internal Precision Targets: For the precision studies, the acceptance criteria (max CV/SD) are internal performance targets, and the reported values are measured against these.
8. The Sample Size for the Training Set
Not applicable. The SMARTLYTE Electrolyte Analyzer is an IVD device based on ion-selective electrode technology, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its performance is based on its hardware, chemistry, and pre-programmed algorithms, which are calibrated and verified through analytical studies.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of this device's technology. The device uses established physical and chemical principles (ion-selective electrodes). Calibrations are performed using certified calibration fluids.
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(128 days)
|
| Chloride Test System | 862.1170 | Class II | CGZ |
| Lithium Test System | 862.3560
Re: K121140
Trade Name: PROLYTE Electrolyte Analyzer Na+/K+/Cl-/Li+ Regulation Number: 21 CFR §862.3560
The PROLYTE Electrolyte Analyzer Na*/K*/Cli/Li is designed for clinical laboratory use by laboratory professionals to assess the levels of Sodium, Potassium, Chloride and Lithium found in whole blood, serum, plasma, and urine of patients. The analysis is performed in-vitro, and neither the analyzer nor any of its components come in contact with the patient.
This analyzer is used by trained laboratory technicians in clinical laboratories to aid in the diagnosis and treatment of paiients with electrolyte imbalance as well as monitoring the lithium levels for those patients taking lithium. These locations routinely conform to CLA regulations, and conduct daily quality control programs.
The PROLYTE is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, potassium, chloride and lithium in whole blood, plasma, serum, and urine samples.
The PROLYTE Sodium Assay is intended to measure sodium in whole blood, plasma, serum, and urine on the PROLYTE Electrolyte Analyzer Na 7K 7CI/Li. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.
The PROLYTE Potassium Assay is intended to measure potassium in whole blood, plasma, serum, and urine on the PROLYTE Electrolyte Analyzer Na */K */C//Li. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.
The PROLYTE Chloride Assay is intended to measure the level of chloride in whole blood, plasma, serum, and urine on the PROLYTE Electrolyte Analyzer Na*/K*/Cli/Li. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The PROLYTE Lithium test system is intended to measure lithium (from the drug lithium carbonate) in whole blood, plasma, or serum on the PROLYTE Electrolyte Analyzer Na*/K*/Cl'/Li. 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).
It is For In Vitro Diagnostic Use.
The PROLYTE Electrolyte Analyzer Na*/K'/Cl/Li* is intended to be a direct replacement for the PROLYTE Electrolyte Analyzer Na K * (K102959). The PROLYTE Na * , K , CI / Li * Electrolyte Analyzer has all the Elookofyo Khayzerman Proyte Electrolyte Analyzer Na/K'/Cl (K102959), with the added feature that the CI ISE sensor may be replaced by a Li* ISE sensor by the end-user.
The PROLYTE Electrolyte Analyzer Na*/K*/Cli/Lif is designed for clinical laboratory professionals to assess the levels of Sodium, Potassium, Chloride and Lithium found in whole blood, plasma, and serum of patients. Sodium, Potassium, and Chloride are also assessed in urine of patients. The analysis and scrum of pairons. Ocularly be analyzer nor any of its components come in contact with the patient.
This bench top analyzer is used by trained laboratory technicians in clinical laboratories to aid in the ring bonen top and freatment of patients with electrolyte imbalance as well for the monitoring drug levels in those patents taking Lithium. These locations routinely conform to CLIA regulations, and conduct daily control programs.
It uses the Diamond Diagnostics Fluid Pack (K031159) which contains in a sealed package the two calibrants required for calibration along with a flush solution and a waste container. The analyzer can be programmed to self-calibrate at set intervals or on request. The analyzer establishes a slope for the electrode by means of the two calibrants. A value for a sample is determined by direct comparison to the calibrants. Mission Controls (K033063) are the recommended quality control material to be used daily.
The provided text describes the PROLYTE Electrolyte Analyzer Na+/K+/Cl-/Li+ and its performance based on non-clinical and clinical testing, primarily for the Lithium (Li+) assay as other analytes were previously cleared.
Here's an analysis of the acceptance criteria and study details based on the provided input:
Acceptance Criteria and Device Performance for PROLYTE Electrolyte Analyzer (K121140)
1. Table of Acceptance Criteria and Reported Device Performance (Lithium only)
The acceptance criteria are implied by the "Spec, BLD" (Specification for Blood) rows in the precision tables and the comparison against predicate device performance.
Precision (for Lithium: Blood, Plasma, Serum)
| Parameter | Acceptance Criteria (Predicate / Specification) | Reported Device Performance (Worst Case Recorded) | Pass/Fail |
|---|---|---|---|
| Within Run Precision (S.D.) | |||
| Whole Blood (0.3 – 2.0 mEq/L reference range) | ≤ 0.03 mEq/L (Specific BLD) | 0.010 mEq/L (Mid-range) | Pass |
| Plasma (0.3 – 2.0 mEq/L reference range) | ≤ 0.03 mEq/L (Specific BLD) | 0.01336 mEq/L (High range) | Pass |
| Serum (0.3 – 2.0 mEq/L reference range) | ≤ 0.03 mEq/L (Specific BLD) | 0.01166 mEq/L (High range) | Pass |
| Run to Run Precision (S.D.) | |||
| Whole Blood (0.3 – 2.0 mEq/L reference range) | ≤ 0.09 mEq/L (Specific BLD) | 0.014 mEq/L (V Low range) | Pass |
| Plasma (0.3 – 2.0 mEq/L reference range) | ≤ 0.09 mEq/L (Specific BLD) | 0.02444 mEq/L (High range) | Pass |
| Serum (0.3 – 2.0 mEq/L reference range) | ≤ 0.09 mEq/L (Specific BLD) | 0.0425 mEq/L (High range) | Pass |
Linearity (Lithium)
| Parameter | Acceptance Criteria (Implied by Predicate) | Reported Slope | Intercept | R² | Pass/Fail |
|---|---|---|---|---|---|
| Whole Blood | High R² (near 1), Slope near 1 | 0.9854 | -0.0285 | 0.9979 | Pass |
| Plasma | High R² (near 1), Slope near 1 | 0.9985 | -0.0315 | 0.9997 | Pass |
| Serum | High R² (near 1), Slope near 1 | 1.0068 | 0.019 | 0.9998 | Pass |
Method Comparison (Lithium vs. Predicate GEMLYTE K082462)
| Parameter | Acceptance Criteria (Implied correlation) | Reported Slope | Intercept | R² | Pass/Fail |
|---|---|---|---|---|---|
| Whole Blood | High R² (near 1), Slope near 1 | 1.0096 | 0.0719 | 0.9947 | Pass |
| Plasma | High R² (near 1), Slope near 1 | 0.9806 | 0.1292 | 0.9971 | Pass |
| Serum | High R² (near 1), Slope near 1 | 0.9977 | 0.0133 | 0.9881 | Pass |
Note on Precision "F" (Fail) for Plasma and Serum within-run precision at V High:
The tables show "F" for Plasma and Serum at the "V High" concentration for within-run precision (Spec, BLD = 0.03). However, the narrative states, "Lithium demonstrated precision within the limits defined below in the reference range, 0.3 to 2.0 mEq/L." The "V High" concentrations (4.41513 and 4.30820 mEq/L) are outside this stated reference range. The "Spec, BLD" of ≤ 0.03 appears to be the acceptance criterion for the reference range (0.3 - 2.0 mEq/L). The reported standard deviations for these V High values, while exceeding 0.03, may be acceptable for concentrations outside the strict clinical reference range or may indicate a different specification applied to the extreme high end which is not explicitly stated. Given the overall conclusion of safety and effectiveness, it's implied these were deemed acceptable.
2. Sample Size Used for the Test Set and Data Provenance
-
Precision Test Set (Lithium):
- Within Run: 30 replicates for each of 5 concentration levels (V Low, Low, Mid, High, V High) for whole blood, plasma, and serum matrices. (Total of 30 samples/level * 5 levels = 150 measurements per matrix).
- Run to Run (Total Precision):
- Plasma/Serum: 40 replicates (measured twice each morning and twice each afternoon for 10 days) for most concentration levels. Some levels had 41 or 44 replicates.
- Whole Blood: 4 groups of 10 replicates, separated by calibration (total of 40 measurements).
- Data Provenance: Not explicitly stated, but the context of an FDA 510(k) submission for IVD devices typically implies data collected in a controlled laboratory setting, often in the US, following GLP/GCP guidelines for clinical studies. It is prospective data collection specifically for these tests.
-
Linearity Test Set (Lithium):
- Whole Blood: 100 samples
- Plasma: 38 samples
- Serum: 44 samples
- Data Provenance: Not explicitly stated, but derived from serially diluted stock solutions. Prospective data.
-
Method Comparison Test Set (Lithium):
- Whole Blood: 94 patient samples
- Plasma: 100 patient samples
- Serum: 91 patient samples
- Data Provenance: "patient samples" implies retrospective or prospective collection from clinical pathology/laboratory settings. The country of origin is not specified, but typically for US regulatory submissions, the data is often generated in-country or by international labs adhering to recognized standards. It's not explicitly stated if it's retrospective or prospective collection, but method comparison studies often use prospectively collected "real-world" patient samples or archived samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This is a medical device for measuring analytes (Sodium, Potassium, Chloride, Lithium) in patient samples. The "ground truth" (or reference method) for such devices is typically established through:
- Reference laboratory methods: For quantitative measurements, this refers to established, highly accurate, and precise analytical methods.
- Comparison to a legally marketed predicate device: The method comparison study directly uses the predicate device's measurements as the reference for comparison, implying the predicate itself is the "ground truth" for regulatory purposes in this context.
No 'experts' in the sense of clinicians or radiologists are typically used to establish ground truth for this type of quantitative IVD assay. The accuracy is determined by analytical methods and comparison to a proven device, not expert consensus on qualitative interpretation.
4. Adjudication Method for the Test Set
Not applicable. Adjudication typically applies to qualitative or semi-quantitative assessments where multiple human interpreters might disagree (e.g., image interpretation). For a quantitative analyzer measuring discrete chemical levels, the output is a numerical value, and the ground truth relies on established analytical methods or comparison to a predicate device, not human subjective assessment needing adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is an In Vitro Diagnostic (IVD) device for quantitative chemical analysis, not an imaging device or AI-assisted diagnostic tool that involves human readers interpreting cases. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study or analysis of human reader improvement with AI assistance is not relevant to this device type.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, the studies presented (precision, linearity, method comparison) are inherently standalone performance studies for the device (the "algorithm" in a broader sense of the instrument's measurement principle and processing) without direct human intervention in the measurement process itself once initiated. The device provides a direct numerical output.
7. Type of Ground Truth Used
- Precision: Internal consistency of the device, measured against statistical definitions (standard deviation, coefficient of variation). The "truth" is the mean of multiple measurements.
- Linearity: Expected values based on serial dilution of known stock solutions. The "truth" is the theoretical concentration.
- Method Comparison: Measurements from a legally marketed predicate device (GEMLYTE K082462). This is the primary "ground truth" for demonstrating substantial equivalence. For the analytes (Na, K, Cl, Li) this is a direct quantitative comparison.
8. Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning or AI development. This device uses ion-selective electrode technology, which is a well-established analytical principle based on electrochemical measurements, not a machine learning model that requires a discrete training phase. The "training" of the device is analogous to calibration, which uses known calibrant solutions.
9. How the Ground Truth for the Training Set Was Established
As noted above, a "training set" for an AI model is not applicable here. However, for the operational aspect of the device (calibration), the "ground truth" is established by:
- The use of "Fluid Pack (K031159) which contains in a sealed package the two calibrants required for calibration." These calibrants would have precisely known concentrations of the target analytes.
- The analyzer "establishes a slope for the electrode by means of the two calibrants." This process essentially "trains" the electrodes to accurately translate electrochemical signals into analyte concentrations.
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(101 days)
Regulation section: 21 CFR § 862.3560 Lithium test system
- 2. Classification: Class II
-
Regulation section: 21 CFR § 862.3560 Lithium test system
- 2. Classification: Class II
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Lithium (LITH) Flex® Reagent Cartridge, Dimension Vista® Drug 4 Calibrator Regulation Number: 21 CFR 862.3560
The LITH method is an in vitro diagnostic test for the quantitative measurement of lithium in human serum and plasma on the Dimension Vista® System. 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).
The Drug 4 CAL is an in vitro diagnostic product for the calibration of the LOCI Digoxin (DIGXN) and Lithium (LITH) methods on the Dimension Vista® System.
The LITH method employs a lithium-specific chromoionophore that forms a complex with the Li+ ion in an alkaline solution. The concentration of lithium in the sample is proportional to the increase in absorbance, which is due to the formation of the dye-lithium complex. The reaction is measured using a Bichromatic (510 and 700 mm) endpoint technique.
The Drug 4 Calibrator is a five (5) level, liquid calibrator. It is packaged as a kit of ten vials per level (A, B, C, D and E), 2.5 mL per vial. The product matrix is liquid human serum and contains digoxin and lithium. This product is sold separately from the Flex® reagent cartridge.
Here's a breakdown of the acceptance criteria and study information for the Dimension Vista® Lithium (LITH) Flex® Reagent Cartridge and Dimension Vista® Drug 4 Calibrator, based on the provided text:
Overview:
The submission focuses on demonstrating "substantial equivalence" to predicate devices. This means the new devices (Dimension Vista® Lithium Flex® Reagent Cartridge and Dimension Vista® Drug 4 Calibrator) perform similarly enough to existing, legally marketed devices (Dimension® Lithium Flex® Reagent Cartridge K011033 and Dimension® Drug Calibrator K011035) that they don't raise new questions of safety or effectiveness. The primary study type is comparative testing.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission, the "acceptance criteria" are implicitly met if the new device performs comparably to the predicate device, as demonstrated through comparative testing. The document states "Comparative testing described in the submission report demonstrates substantial equivalent performance."
Here’s a table summarizing the features compared, which serve as the basis for demonstrating substantial equivalence:
Dimension Vista® Lithium (LITH) Flex® Reagent Cartridge vs. Predicate (K011033)
| Feature | Acceptance Criteria (Predicate: Dimension® Lithium (LI) K011033) | Reported Device Performance (Dimension Vista® Lithium (LITH) K4150) |
|---|---|---|
| Intended Use | Quantitative measurement of lithium in human serum and plasma on Dimension® systems for drug dosage assurance in mental disturbances. | Quantitative measurement of lithium in human serum and plasma on the Dimension Vista® System for drug dosage assurance in mental disturbances. (Identical) |
| Sample Type | Serum and Sodium Heparin Plasma | Serum and Sodium Heparin Plasma |
| Measuring Range | 0.20 - 5.00 mmol/L | 0.20 - 3.00 mmol/L |
| Sample Size | 10 µL | 2 µL |
| Measurement | Bichromatic endpoint (540 and 700 nm) | Bichromatic endpoint (510 and 700 nm) |
Dimension Vista® Drug 4 Calibrator vs. Predicate (K011035)
| Feature | Acceptance Criteria (Predicate: Dimension® Drug Calibrator K011035) | Reported Device Performance (Dimension Vista® DRUG 4 CAL KC460A) |
|---|---|---|
| Intended Use | Calibration of DIG, LI, PHNO, PTN, and THEO methods on Dimension Vista® System. | Calibration of LOCI Digoxin (DIGXN) and Lithium (LITH) methods on the Dimension Vista® System. |
| Matrix | Human serum based | Human serum based |
| Preparation | Liquid: Provided ready to use. | Liquid: Provided ready to use. |
| Target Concentrations | Level 1: ≤ 0.20 mmol/L | |
| Level 2: 0.80 - 1.00 mmol/L | ||
| Level 3: 1.71 - 1.89 mmol/L | ||
| Level 4: 3.42 - 3.78 mmol/L | ||
| Level 5: 5.22 - 5.78 mmol/L | Level 1: ≤ 0.20 mmol/L | |
| Level 2: 0.77 - 1.15 mmol/L | ||
| Level 3: 1.67 - 2.00 mmol/L | ||
| Level 4: 3.35 - 3.85 mmol/L | ||
| Level 5: 5.12 - 5.89 mmol/L | ||
| Storage | Store at 2 to 8 °C. | Store at 2 - 8 °C. |
2. Sample Size Used for the Test Set and Data Provenance
The document states "Comparative testing described in the submission report demonstrates substantial equivalent performance." However, the exact sample sizes for the test set (e.g., number of patient samples, controls) are not specified within the provided text.
The data provenance is also not explicitly stated (e.g., country of origin, retrospective/prospective). As an in vitro diagnostic device, it's highly likely that samples would be human serum and plasma, but the source specifics are missing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable and not provided in the context of this device. This is a quantitative chemical assay, not an imaging device or diagnostic interpretation requiring expert human adjudication. The "ground truth" for calibrators and reagent cartridges like these is typically established through analytical methods, reference materials, and specified concentrations, not expert consensus.
4. Adjudication Method for the Test Set
Not applicable and not provided. As explained in point 3, this is a quantitative chemical assay, not a diagnostic interpretation that would involve adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is typically for evaluating a diagnostic aid that assists human readers (e.g., AI in radiology). The devices in question are reagents and calibrators for a laboratory instrument, not tools for human interpretation.
6. If a Standalone Performance Study was Done
Yes, in essence, standalone performance was assessed as part of the "comparative testing" mentioned. For an in vitro diagnostic device, demonstrating performance against a predicate device (rather than a human reader) is the standard. The device's performance properties (e.g., precision, measuring range, analytical specificity) would be evaluated when operating on its own as designed, and then these results would be compared to the predicate. The document states "Comparative testing described in the submission report demonstrates substantial equivalent performance," indicating the new device's performance was measured.
7. The Type of Ground Truth Used
The ground truth for these types of devices is based on analytical validation and reference methods.
For the Lithium Flex® Reagent Cartridge: The "ground truth" for lithium concentration in samples would be established by reference methods or validated comparative methods, against which the device's quantitative measurements are compared to assess accuracy, precision, and linearity.
For the Drug 4 Calibrator: The "ground truth" for the calibrator's target concentrations (Levels 1-5) is established by precise formulation and measurement against recognized standards. The matrix itself (human serum) is a specified component.
8. The Sample Size for the Training Set
Not applicable and not provided. These are chemical reagents and calibrators for an IVD assay, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The development and optimization of such reagents involve experimental design, formulation studies, and analytical verification, rather than machine learning training.
9. How the Ground Truth for the Training Set was Established
Not applicable and not provided. As explained in point 8, there is no "training set" in the context of these devices.
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(163 days)
|
| Calcium Test System | 862.1145 | Class II | JFP |
| Lithium Test System | 862.3560
The GemLyte is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, potassium, chloride, calcium and lithium in whole blood, plasma and serum, and prediluted urine samples.
The GemLyte Potassium Assay is intended to measure potassium in whole blood, plasma, serum, and urine on the GemLyte Electrolyte Analyzer. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.
The GemLyte Sodium Assay is intended to measure sodium in whole blood, plasma, serum, and urine on the GemLyte Electrolyte Analyzer. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.
The GemLyte Chloride Assay is intended to measure the level of chloride in whole blood, plasma, serum, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The GemLyte Calcium Assay is intended to measure the ionized calcium level in whole blood, plasma and serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
The GemLyte Lithium Assay is intended to measure lithium (from the drug lithium carbonate) in whole blood, plasma and serum. 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).
The GemLyte is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, potassium, chloride, calcium and lithium in serum, plasma, whole blood and prediluted urine samples. GemLyte analyzer is designed with the user in mind, it is fully automated with simple .Yes' or 'No' commands for menu navigation. This simple interface insures that not only will the analyzer be easy to use for quick analysis, (less than a minute for samples), but also that the testing of samples can be done by even non-skilled operators with relative ease. The analyzer self-calibrates using Diamond Diagnostics Fluid Pack (510(k) 013850) every 4 hours through out the day or on request. Sodium, potassium, chloride and calcium are commonly measured for use in the diagnosis and management of patients with a broad range of renal, metabolic and cardiovascular disorders. Lithium is a drug used to treat mental illness. Mission controls (510 (k) 033063) are the recommended quality control material to be used daily.
The provided text describes the 510(k) summary for the GemLyte Electrolyte Analyzer. Here's a breakdown of the acceptance criteria and the study information as requested:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the GemLyte Electrolyte Analyzer are primarily based on achieving performance similar to or within specified limits of the predicate device (AVL 9180 (K961458)) and meeting internal reproducibility guidelines. The reported device performance metrics are presented as "reproducibility" (precision) and "correlation" (agreement with predicate device).
Acceptance Criteria (Performance Specifications)
| Metric | Parameter | Matrix | Acceptance Criteria (Internal/Predicate Comparison) | Reported Device Performance (Achieved) |
|---|---|---|---|---|
| Reproducibility (Precision) | ||||
| Within-Run | Na+ | Blood/Plasma/Serum | C.V. ≤1% | C.V. ≤0.6% |
| K+ | Blood/Plasma/Serum | C.V. ≤1.5% | C.V. ≤1.5% | |
| Cl- | Blood/Plasma/Serum | C.V. ≤2% | C.V. ≤1% | |
| Ca++ | Blood/Plasma/Serum | SD ≤0.02 | SD ≤0.02 | |
| Li+ | Blood/Plasma/Serum | SD ≤0.03 | SD ≤0.04 (Note: This is slightly higher than the specified SD ≤0.03 in the "Reproducibility" table but within the "Summary of nonclinical tests" table. The text states "Results are within performance specifications.") | |
| Na+ | Urine | C.V. ≤5% | C.V. ≤ 5% | |
| K+ | Urine | C.V. ≤5% | C.V. ≤ 5% | |
| Cl- | Urine | C.V. ≤5% | C.V. ≤ 2% (Note: This is better than the specified C.V. ≤ 5% in the "Reproducibility" table but within the "Summary of nonclinical tests" table. The text states "Results are within performance specifications.") | |
| Between-Run | Na+ | Serum/Blood/Serum | C.V. ≤2% | C.V. ≤1.5% |
| K+ | Serum/Blood/Serum | C.V. ≤3% | C.V. ≤3% | |
| Cl- | Serum/Blood/Serum | C.V. ≤3% | C.V. ≤3% | |
| Ca++ | Serum/Blood/Serum | SD ≤0.06 | SD ≤0.06 | |
| Li+ | Serum/Blood/Serum | SD ≤0.09 | SD ≤0.09 | |
| Na+ | Urine | C.V. ≤5% | C.V. ≤4% | |
| K+ | Urine | C.V. ≤5% | C.V. ≤5% | |
| Cl- | Urine | C.V. ≤5% | C.V. ≤3% | |
| Linearity | All | All claimed range | Correlation coefficients > 0.99 (regression analysis) | All correlation coefficients were greater than 0.99. |
| Correlation to Predicate Device | All | All sample types | Correlation coefficients > 0.99 (regression analysis) | "Regression analysis show good correlation to predicate devices for all sample types, whole blood, plasma, serum and urine with correlation coefficients typically greater than 0.99." Specific R² values are provided in the tables above, all of which are ≥0.9687 (Chloride in Serum). |
2. Sample Size Used for the Test Set and Data Provenance
The test set for the correlation studies used the following sample sizes:
- Whole Blood: Sodium (n=128), Potassium (n=112), Chloride (n=123), Calcium (n=124), Lithium (n=123)
- Plasma: Sodium (n=105), Potassium (n=107), Chloride (n=115), Calcium (n=123), Lithium (n=115)
- Serum: Sodium (n=122), Potassium (n=127), Chloride (n=125), Calcium (n=120), Lithium (n=131)
- Urine (Spot): Sodium (n=118), Potassium (n=108), Chloride (n=118)
Data Provenance: The document does not explicitly state the country of origin. It indicates that samples were "collected for testing on the GemLyte as well as another predicate device, the AVL 9180." The language used (e.g., "mmol/L") is standard for clinical chemistry. The study appears to be prospective in nature, as it describes a setup for collecting and testing samples on two devices for comparison.
For precision (reproducibility) studies:
- Within-Run: 30 replicates for each sample type (blood, serum, urine).
- Between-Run: 2 runs per day with 2 replicates per run for 10 days for each sample type.
- Potassium (Whole Blood Specific): Multiple instruments (4) tested over a period of an hour due to instability.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of device (electrolyte analyzer) does not typically rely on "expert" interpretation for ground truth, unlike imaging or diagnostic AI. The "ground truth" for the correlation study is the measurement obtained from the predicate device (AVL 9180), which is an established, legally marketed device for the same purpose. The text states, "Clinical testing was conducted to demonstrate the correlation of Diagnostics GemLyte Analyzer to predicate devices operated by trained personnel." It clarifies that the comparison device was operated by "trained personnel," implying standard laboratory practice, but does not specify "experts" in the sense of clinical specialists like radiologists.
4. Adjudication Method for the Test Set
Not applicable. As explained above, the ground truth is established by the predicate device's readings, not by expert consensus or adjudication. The study design is a direct comparison of measurements between two devices.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an imaging or diagnostic AI device that involves human readers interpreting cases. It is an automated electrolyte analyzer.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, the studies presented are standalone performance evaluations for the GemLyte Electrolyte Analyzer. The device is an automated system; its performance is measured directly (e.g., reproducibility, linearity) and compared against a predicate device's measurements, not against human performance in a diagnostic reading task.
7. Type of Ground Truth Used
The ground truth for the clinical correlation studies was the measurements obtained from the predicate device, AVL 9180. For within-run precision, the ground truth is implicitly the true stable concentration within the sample, with the device aiming to measure it consistently. For linearity, the ground truth was prepared standard solutions (dilutions from starting stock solutions).
8. Sample Size for the Training Set
The document does not specify a separate "training set" in the context of an AI/ML model for this device. The GemLyte Electrolyte Analyzer is based on ion-selective electrode (ISE) technology, not machine learning. Therefore, it does not typically involve a "training set" in the computational sense. The device is calibrated using internal calibration solutions and Diamond Diagnostics Fluid Pack (510(k) 013850) as described in the calibration section.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" for an AI/ML model, this question is not applicable in the typical sense.
For the device's internal calibration, the "ground truth" would be the known concentrations of the calibration solutions, which are presumably traceable to established standards. The text states:
- "The analyzer self-calibrates using Diamond Diagnostics Fluid Pack (510(k) 013850) every 4 hours through out the day or on request."
- "The GemLyte performs a 2-point calibration (3-point calibration if lithium) every 4 hours or software permits calibration on demand. A 1-point calibration is performed automatically with each measurement."
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(144 days)
Re: K082001
Trade/Device Name: Diazyme Liquid Stable Enzymatic Lithium Regulation Number: 21 CFR 862.3560
Diazyme Liquid Enzymatic Assay Kit is for quantitative in vitro determination of Lithium in human serum. Measurements of Lithium are carried out essentially to ensure that proper drug dosage is administered in the treatment of patient suffering from bipolar disorder and to avoid toxicity.
Not Found
The provided text (from {0} to {2}) is a 510(k) clearance letter from the FDA for a medical device called "Diazyme Liquid Stable Enzymatic Lithium Assay." This document primarily focuses on regulatory approval and equivalence to a predicate device. It does not contain specific information regarding acceptance criteria, study details, or performance metrics in the format requested.
Therefore, most of the information required to populate the table and answer the detailed questions is not present in the provided text. The document is a clearance letter, not a study report or clinical trial summary.
Here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this document | Not specified in this document |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not specified.
- Qualifications of experts: Not specified.
4. Adjudication method for the test set:
- Not specified.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:
- Not specified. This type of study is more common for imaging devices or AI-assisted diagnostics, not a liquid assay.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This device is an "Enzymatic Lithium Assay," which is a lab test, not an algorithm in the typical sense of AI/ML. The concept of "standalone performance" as it applies to AI without human-in-the-loop is not relevant here. The device itself performs the assay.
7. The type of ground truth used:
- For an assay device, the "ground truth" would typically refer to a reference method or validated comparative method against which the new assay's measurements are compared. This is not specified in the document.
8. The sample size for the training set:
- Not specified. (Note: For a traditional lab assay, "training set" is not a standard term like it is for AI/ML. There would be R&D and validation work, but the concept of a "training set" for an algorithm isn't directly applicable.)
9. How the ground truth for the training set was established:
- Not specified. (As above, "training set" concept is not directly applicable.)
In summary, the provided FDA clearance letter indicates the device's regulatory pathway and its "substantially equivalent" status to a predicate device, but it does not detail the technical performance studies and their specific methodologies.
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(465 days)
IN 46250
MAR 2 1 2008
Re: K063684 Trade/Device Name: Lithium Test System Regulation Number: 21 CFR 862.3560
In vitro test for the quantitative determination of lithium in human serum and plasma on Roche/Hitachi cobas c systems. Measurements of lithium are used as an aid in the management of patients taking lithium for the treatment of mental disturbances such as manic-depressive illness (bipolar disorder).
The cassette cobas c501 Lithium contains an in vitro diagnostic reagent system intended for use on Roche/Hitachi cobas c systems for the quantitative determination of lithium in human serum and plasma. The test principle is colorimetric.
The provided text describes a 510(k) submission for the cobas c501 Lithium test system. It outlines the device's intended use, its similarities and differences to a predicate device, and various performance characteristics. However, the document does not contain information typically associated with acceptance criteria or studies proving device performance for AI/ML-driven diagnostics, as none of the requested fields directly apply to this type of medical device.
The device described is an in vitro diagnostic reagent system for the quantitative determination of lithium in human serum and plasma, using a colorimetric test principle. This is a chemical assay, not an AI/ML-driven diagnostic device. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics (like sensitivity, specificity, AUC, and human reader improvement) are not applicable to this submission.
The document focuses on demonstrating substantial equivalence to a predicate device (COBAS INTEGRA ISE Direct) by comparing analytical performance characteristics relevant to chemical assays.
Given the nature of the device, I cannot provide the requested information. The document does not describe:
- A table of acceptance criteria and reported device performance in relation to AI/ML metrics. It provides analytical performance characteristics like precision, linearity, and interference.
- Sample size used for the test set and data provenance: While method comparison data is mentioned (e.g., Passing Bablok regression), the specific sample size and data provenance for demonstrating equivalence are not detailed in the provided text.
- Number of experts and qualifications for ground truth: Not applicable for a chemical assay.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used (expert consensus, pathology, outcomes data): Not applicable in the AI/ML sense. The ground truth for a chemical assay would be reference methods (e.g., Atomic Absorption Spectroscopy as mentioned for traceability).
- Sample size for the training set: Not applicable as it's not an AI/ML model.
- How ground truth for the training set was established: Not applicable.
However, I can extract the analytical performance characteristics that are presented, which serve as evidence of the device's performance for this type of IVD.
Analytical Performance Characteristics of the cobas c501 Lithium (Modified Device)
While the typical "acceptance criteria" for AI/ML are not present, the following analytical performance characteristics are reported for the cobas c501 Lithium system, indicating its performance compared to the predicate and overall suitability:
| Performance Characteristic | Acceptance Criteria (Implicit via predicate comparison or industry standards for IVDs) | Reported Device Performance (cobas c501 Lithium) |
|---|---|---|
| Precision | Demonstrated precision comparable to or better than predicate. | Within run CV: |
| 1.7% @ 0.77 mmol/L | ||
| 1.0% @ 2.38 mmol/L | ||
| 1.9% @ 0.46 mmol/L | ||
| 1.2% @ 1.40 mmol/L | ||
| Total: | ||
| 2.2% @ 0.79 mmol/L | ||
| 1.3% @ 2.42 mmol/L | ||
| 2.3% @ 0.61 mmol/L | ||
| 1.6% @ 1.62 mmol/L | ||
| Endogenous Interferences | No significant interference at specified levels for common interferents. | Hemolysis: No significant interference up to H index of 1000 |
| Icterus: I index of 37 for conjugated and 43 for unconjugated bilirubin | ||
| Lipemia: L index of 2000 | ||
| Exogenous Interferences | No significant interference from common exogenous substances. | NH4Cl: 19.8 umol/L |
| NaCl : 140 mmol/L | ||
| KCl : 4 mmol/ L | ||
| CaCl2: 2.4 mmol/L | ||
| MgCl2: 0.9 mmol/L | ||
| FeCl3: 1.04 mg/L | ||
| Cu (NO3)2: 1.15 mmol/L | ||
| ZnCl2: 1.07 mmol | ||
| (none of these are in the physiological key interference range) | ||
| In very rare cases gammopathy | ||
| Limit of Detection (LOD) | Clinically meaningful detection limit. | 0.05 mmol/L |
| Limit of Blank (LOB) | Defined blank. | 0.03 mmol/L |
| Measuring Range | Clinically relevant measurable range. | 0.05-3.00 mmol/L |
| Extended measuring range: 0.05-6.00 mmol/L |
Study Information (as it pertains to this IVD):
The document mentions "Performance evaluation" was done for several characteristics, but does not provide details on specific study designs, sample sizes, or data provenance beyond what is implicit in standard IVD validation.
- Sample size for test set and data provenance: Not explicitly stated for specific performance studies. The method comparison data includes parameters like Passing Bablok regression (y = 1.037x + 0.004, $\tau$ = 0.940) and Linear regression (y = 1.044x -0.000, r = 0.995) which imply a comparison study with an unspecified number of samples. The data provenance (e.g., country of origin, retrospective/prospective) is not provided.
- Number of experts and qualifications for ground truth: Not applicable for a chemical assay. The ground truth for this device would be established by reference methods.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone performance: The performance characteristics listed (precision, interference, limits) represent the standalone analytical performance of the device. This is the equivalent of "algorithm only" performance for a chemical assay.
- Type of ground truth: For analytical performance testing, the ground truth would be established by validated reference methods or materials (e.g., Atomic Absorption Spectroscopy for traceability, or gravimetrically prepared reference materials for calibrators).
- Sample size for the training set: Not applicable, as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
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(300 days)
Theophylline, ISE Calibrator 1, ISE Calibrator 2&3, TDM Calibration set B Regulation Number: 21 CFR 862.3560
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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(118 days)
Milano Italy
AUG - 2 2007
Re: K070987 Trade/Device Name: Multigent Lithium Regulation Number: 21 CFR§862.3560
A lithium test system is a device intended to measure lithium levels in serum or plasma. Measurements of lithium are used to aid in the management of individuals taking lithium for the treatment of mental disturbances, such as manic-depressive illness (bipolar disorder). For use on Architect and Aeroset analyzers.
The Multigent Lithium test is a spectrophotometric method, which can be readily adapted to automated clinical chemistry analyzers. Lithium present in the sample reacts with a substituted porphyrin compound at an alkaline pH, resulting in a change of absorbance, which is directly proportional to the concentration of lithium in the sample.
Here's a breakdown of the acceptance criteria and study information for the Multigent Lithium device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Metric (Predicate Device: Infinity Lithium Liquid Stable Reagent assay on Hitachi 911 Analyzer) | Achieved Performance (Multigent Lithium) |
|---|---|---|
| Correlation | Correlation coefficient: Not explicitly stated for acceptance, but implied to be high for equivalence. | AEROSET System: 0.999 |
| ARCHITECT c8000 System: 0.999 | ||
| Slope | Slope: Not explicitly stated for acceptance, but implied to be near 1 for equivalence. | AEROSET System: 1.013 |
| ARCHITECT c8000 System: 0.991 | ||
| Y-intercept | Y-intercept: Not explicitly stated for acceptance, but implied to be near 0 for equivalence. | AEROSET System: -0.025 mmol/L |
| ARCHITECT c8000 System: -0.004 mmol/L | ||
| Precision (%CV) | %CV: Not explicitly stated for acceptance, but implied to be functionally acceptable for clinical use. | AEROSET System: Level 1: 4.76%, Level 2: 3.67%, Level 3: 2.96% |
| ARCHITECT c8000 System: Level 1: 2.53%, Level 2: 1.88%, Level 3: 2.02% | ||
| Linearity (Upper Limit) | Linearity: Not explicitly stated for acceptance, but implied to cover the clinical range. | Up to 3.51 mmol/L |
| Limit of Quantitation (Sensitivity) | Sensitivity: Not explicitly stated for acceptance, but implied to be clinically relevant. | 0.10 mmol/L |
Note: The acceptance criteria are implicitly defined by the claim of "similar Performance Characteristics" and "substantially equivalent" to the predicate device. Specific numerical thresholds for acceptance are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the comparative performance studies. It mentions "comparative performance studies were conducted," but details on the number of samples are absent.
- Data Provenance: Not specified. It's unclear if the data was collected retrospectively or prospectively, or the country of origin.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a diagnostic reagent for measuring lithium levels, which are typically determined by laboratory analysis and not by expert human interpretation of images or other subjective data. The "ground truth" in this context would be the actual concentration of lithium in the samples, as determined by the predicate device (Infinity Lithium Liquid Stable Reagent assay on the Hitachi 911 Analyzer) or a reference method.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this study involves objective chemical measurements, not subjective interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for devices that involve human interpretation of diagnostic images (e.g., radiology AI), not for objective chemical assays like this lithium test.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, this study is inherently a standalone performance evaluation of the Multigent Lithium assay. It compares the analytical performance of the new assay directly against a predicate device, without involving human interpretation as an outcome. The device itself performs the measurement.
7. The Type of Ground Truth Used
The ground truth for the device's performance comparison was the results obtained from the predicate device, the Infinity Lithium Liquid Stable Reagent assay on the Hitachi 911 Analyzer.
8. The Sample Size for the Training Set
Not applicable. For a diagnostic reagent intended for chemical measurement, there isn't typically a "training set" in the machine learning sense. The assay is developed based on chemical principles and extensively tested for analytical performance.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there isn't a traditional "training set" with ground truth in this context. The development process would involve optimizing the reagent's formulation and reaction conditions to accurately measure lithium, with performance validated against reference methods and established predicate devices.
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