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510(k) Data Aggregation
(255 days)
DCF
The Optilite Low Level Albumin Kit is intended for the quantitative in vitro measurement of albumin in CSF, urine and serum using the Binding Site Optilite analyser to aid in the diagnosis of kidney and intestinal diseases. This test should be used in conjunction with other laboratory and clinical findings.
The Optilite Low Level Albumin Kit is comprised of the following reagents: Antiserum, Calibrator and Controls, and Reaction Buffer. In Optilite kits, the antiserum reagent and reaction buffer are supplied in a single wedge with a chamber for each fluid. They are therefore labelled as a single component Optilite LLAlb Reagent. The Antigen Excess Control does not have an assigned value.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Precision | Total precision: %CV |
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(208 days)
DCF
The Human Microalbumin kit for use on SPAPLUS kit is intended for the quantitative measurement of human albumin in human urine using the SPAPLUS turbidimetric analyser. Measurement of albumin in human urine is an aid in the diagnosis of renal disease. This test should be used in conjunction with other laboratory and clinical findings. For in vitro diagnostic use only.
Not Found
This document is a 510(k) premarket notification decision letter from the FDA for a medical device. It does not include detailed information about acceptance criteria or specific study results that prove the device meets those criteria.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide information on:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and data provenance
- Number of experts and qualifications for ground truth
- Adjudication method
- MRMC comparative effectiveness study results
- Standalone performance results
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
The document primarily states the FDA's determination that the device, "Human Microalbumin kit for use on SPAPLUS kit," is substantially equivalent to legally marketed predicate devices. It lists the "Indications for Use" for the device, which is "intended for the quantitative measurement of human albumin in human urine using the SPAPLUS turbidimetric analyser. Measurement of albumin in human urine is an aid in the diagnosis of renal disease. This test should be used in conjunction with other laboratory and clinical findings. For in vitro diagnostic use only."
To obtain the information you requested, you would typically need to consult the full 510(k) submission summary or associated clinical/analytical study reports, which are not included in this decision letter.
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(54 days)
DCF
Urine/CSF Albumin:
The Urine/CSF Albumin reagent is intended to be used for the quantitation of albumin concentration in human urine and cerebrospinal fluid (CSF) on the Beckman Coulter AU clinical chemistry systems as an aid in the diagnosis of kidney diseases. For in vitro diagnostic use only.
Urine/CSF Albumin Calibrator:
The Urine/CSF Albumin calibrator is intended to be used to calibrate the Urine/CSF Albumin reagent on the Beckman Coulter AU clinical chemistry systems. For in vitro diagnostic use only.
The Urine/CSF Albumin reagent kit is in a liquid, ready to use format. There are two kit concepts available. Each kit concept contains an R1 and an R2 reagent vial with different fill volumes. The Urine/CSF Albumin calibrator kit is in a liquid, ready to use format and contains 5 x 2 mL calibrator levels. It is packaged and sold separately to the reagent kit. Urine/CSF Albumin reagent is used to measure albumin concentration by a turbidimetric method. In the reaction, anti-human serum albumin antibodies combine with albumin from the sample to form immune complexes that scatter light in proportion to their size, shape and concentration. The absorbance of these aggregates is proportional to the albumin concentration in the sample. Change in absorbance is measured at 380nm with subtraction of a reference wavelength at 800nm. The Urine/CSF Albumin reagent and calibrator is designed for optimal performance on Beckman Coulter AU clinical chemistry analyzers.
This looks like a 510(k) premarket notification for a medical device: "Urine/CSF Albumin and Urine/CSF Albumin Calibrator." The document describes various analytical performance studies to demonstrate substantial equivalence to predicate devices, rather than a clinical study establishing a new clinical claim. Therefore, some of the requested information (like MRMC study effect size, number of experts for ground truth, adjudication method, and training set details) is not directly applicable to this type of submission.
However, I can extract and organize the available "acceptance criteria" (implicitly, the performance targets demonstrated) and "device performance" (the results of the studies).
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a submission demonstrating equivalence through analytical performance, the "acceptance criteria" are implied by the precision, linearity, sensitivity, and interference limits typically expected for such devices, and demonstrated by the successful results presented. The "reported device performance" is the direct result from the validation studies.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Precision (Within-Run/Repeatability) | Urine: |
- Low: 0.02 SD (0.9% CV)
- Mid: 0.02 SD (0.6% CV)
- High: 0.3 SD (1.4% CV)
CSF: - Low: 0.07 SD (1.0% CV)
- Mid: 0.4 SD (1.6% CV)
- High: 0.7 SD (1.9% CV) |
| Precision (Within Laboratory/Total Imprecision) | Urine: - Low: 0.07 SD (4.3% CV)
- Mid: 0.08 SD (2.5% CV)
- High: 0.4 SD (2.1% CV)
CSF: - Low: 0.11 SD (1.8% CV)
- Mid: 0.6 SD (2.4% CV)
- High: 0.9 SD (2.5% CV) |
| Analytical Range (Linearity) | Urine: 0.7 - 45 mg/dL (acceptable linearity demonstrated)
CSF: 1 - 45 mg/dL (acceptable linearity demonstrated) |
| Reagent Shelf-Life Stability | 18 months at 2-8°C |
| Calibrator Shelf-Life Stability | 18 months at 2-8°C |
| Reagent On-Board Stability | 60 days |
| Calibration Frequency | 60 days |
| Calibrator Open Vial Stability | 30 days |
| Sensitivity (LoB) | Urine: 0.00 mg/dL
CSF: 0.00 mg/dL |
| Sensitivity (LoD) | Urine: 0.07 mg/dL
CSF: 0.13 mg/dL |
| Sensitivity (LoQ) (≤ 0.7 mg/dL for urine, ≤ 1.0 mg/dL for CSF) | Urine: 0.70 mg/dL
CSF: 0.70 mg/dL (met acceptance criteria) |
| Interference (No Significant Interference: ≤ ± 10% or ± 0.2 mg/dL) | Urine: - Calcium: NSI up to 78 mg/dL
- Creatinine: NSI up to 300 mg/dL
- Glucose: NSI up to 3000 mg/dL
- Urea: NSI up to 5000 mg/dL
- Ascorbic Acid: NSI up to 500 mg/dL
- Citrate: NSI up to 50 mg/dL
- Magnesium: NSI up to 400 mg/dL
- Oxalate: NSI up to 30 mg/dL
- Conjugated Bilirubin: NSI up to 40 mg/dL
- Hemoglobin: NSI up to 500 mg/dL
- Acetone: NSI up to 350 mg/dL
- Uric Acid: NSI up to 10 mg/dL
- Urobilinogen: NSI up to 2.25 mg/dL
- Acetaminophen: NSI up to 300 mg/dL
- Ibuprofen: NSI up to 400 mg/dL
- Metronidazole: NSI up to 600 mg/dL
- 5-aminosalicylic acid: NSI up to 150 mg/dL
CSF: - Hemoglobin: NSI up to 500 mg/dL
- Conjugated Bilirubin: NSI up to 40 mg/dL |
| Prozone Tolerance | All samples from upper end of linear range up to claimed prozone tolerance generated a flagged result (indicating a result above the linear range), meaning no false low readings for high concentrations. Prozone high pool tested at ≥ 2000 mg/dL. |
| Method Comparison (Urine) (vs. commercially available assay) | Slope = 1.09, Intercept = 0.03 mg/dL, r = 1.0; Sample range = 0.81 - 40.7 mg/dL (n=131) |
| Method Comparison (CSF) (vs. commercially available assay) | Slope = 1.05, Intercept = -0.77 mg/dL, r = 0.99; Sample range = 1.72 - 41.2 mg/dL (n=131) |
2. Sample Size Used for the Test Set and Data Provenance
- Precision (Repeatability and Total Imprecision): 3 sample levels (Low, Mid, High) for both Urine and CSF. Each level analyzed in duplicate, twice daily, over 20 working days (n=80 total measurements per level).
- Data Provenance: Pooled human urine samples (spiked with purified human serum albumin) and pooled human CSF samples (diluted or spiked with purified human serum albumin). Origin country not specified but implied to be from samples handled in a clinical laboratory setting within the context of a US FDA submission. Prospective for the purpose of the study.
- Analytical Range (Linearity): 11 linearity concentration levels. Each dilution assayed in quadruplicate.
- Data Provenance: Urine and CSF pools prepared by spiking with HSA or dilution. Origin country not specified. Prospective for the purpose of the study.
- Sensitivity (LoB, LoD, LoQ):
- LoB/LoD: Replicate measurements on blank and low-level samples using three reagent lots. 60 blank replicates per reagent lot and 60 low-level sample replicates per reagent lot (total of 180 blanks and 180 low-level samples across 3 lots). Comprised of 4 blank samples and 4 low-level samples for urine and CSF, run 5-fold for 3 days. Four separate saline pools were used as blanks.
- LoQ: Six pools (0.1, 0.2, 0.35, 0.5, 0.7, 1 mg/dL albumin in urine and CSF). Each pool measured in duplicate, twice daily, over 20 working days (n=80 total measurements per pool).
- Data Provenance: Saline for blanks, quantified urine and CSF pools (diluted with saline) for low-level samples, and spiked urine and CSF pools for LoQ. Origin country not specified. Prospective for the purpose of the study.
- Interferences: Urine and CSF pools tested at two different albumin concentrations (1.5-3 mg/dL and 10-20 mg/dL for urine; 10-20 mg/dL and 25-35 mg/dL for CSF). Each interferent concentration tested in quadruplicate.
- Data Provenance: Pooled human urine and CSF samples, spiked with purified human serum albumin and various interfering substances. Origin country not specified. Prospective for the purpose of the study.
- Prozone: Human urine and CSF spiked with human serum to create a prozone high pool (≥ 2000 mg/dL). Prozone panels run n=3.
- Data Provenance: Human urine and CSF, spiked. Origin country not specified. Prospective for the purpose of the study.
- Method Comparison (Urine): n = 131 patient urine samples.
- Data Provenance: Patient urine samples. Origin country not specified. Retrospective/prospective (typically, such studies use archived or freshly collected patient samples).
- Method Comparison (CSF): n = 131 patient CSF samples.
- Data Provenance: Patient CSF samples. Origin country not specified. Retrospective/prospective (typically, such studies use archived or freshly collected patient samples).
- Reference Interval Validation (Urine): 20 urine samples.
- Data Provenance: Urine samples. Origin country not specified. Prospective for the purpose of validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is an in vitro diagnostic (IVD) device for quantitative measurement. The "ground truth" for the analytical performance studies is established by the known concentrations of calibrators, spiked samples, or comparison to a cleared reference method, not by expert interpretation.
4. Adjudication Method for the Test Set
Not applicable. As described above, "ground truth" is analytical, not based on expert review and 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 an IVD device, not an AI-assisted diagnostic imaging or interpretation device that would involve human "readers." The device quantifies albumin concentration directly.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Yes, the device (Urine/CSF Albumin reagent and calibrator on Beckman Coulter AU clinical chemistry systems) is a standalone algorithm/instrument-based system that quantifies albumin concentration. Its performance is evaluated analytically, without a human-in-the-loop component for the direct measurement itself. Human oversight and interpretation of the numerical results are part of clinical practice, but the device's measurement function is autonomous.
7. The Type of Ground Truth Used
The "ground truth" or reference for the analytical performance studies relies on:
- Known concentrations: For precision, linearity, and sensitivity studies, this is achieved by using prepared pools with known added amounts of human serum albumin (HSA) or specific dilutions.
- Traceability to a Certified Reference Material: The Urine/CSF Albumin calibrator values are traceable to the International Federation of Clinical Chemistry Certified Reference Material ERM® - DA470k.
- Comparison to a legally marketed predicate device/method: For method comparison studies, the results are compared against another commercially available and presumably FDA-cleared assay for Urine Albumin and CSF Albumin.
- Literature-based reference intervals: Expected values/reference ranges are drawn from established medical literature.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/Machine Learning algorithm that requires a "training set" in the conventional sense for diagnostic image interpretation or similar tasks. It's an immunoassay for quantitative analysis. The development process would involve internal R&D tests and optimization, but a defined training set for an AI model is not relevant here.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" in the context of an AI/ML algorithm.
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(439 days)
DCF
Human Albumin CSF Kit for use on SPAPLUS is intended for the in-vitro quantification of human albumin in serum and cerebrospinal fluid (CSF) samples on the SPAPLUS analyser. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases in conjunction with other laboratory and clinical findings.
Not Found
This document is a 510(k) clearance letter from the FDA for "The Binding Site Human Albumin CSF kit for use on SPAplus". It confirms that the device is substantially equivalent to legally marketed predicate devices.
The document does not contain a detailed study report with acceptance criteria and device performance as described in your request. It's a regulatory approval, not a scientific publication presenting study data.
Therefore, I cannot provide the specific information requested about acceptance criteria, sample sizes, ground truth establishment, or expert qualifications based on this document. These details would typically be found in the 510(k) submission itself or in a separate study report, not in the clearance letter.
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(210 days)
DCF
The Tina-quant Albumin Gen.2 assay is an immunoturbidimetric assay intended for the quantitative determination of albumin in human urine on Roche/Hitachi cobas c systems. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.
The Tina-quant Albumin Gen. 2 - cobas c 311 urine assay employs an immunoturbidimetric test in which anti-albumin antibodies react with the antigen in the sample to form antigen/antibody complexes which, following agglutination are determined turbidimetrically.
The provided document describes the Tina-quant Albumin Gen. 2 Assay, an immunoturbidimetric test for quantitative determination of albumin in human urine. The submission primarily focuses on establishing substantial equivalence to a previously cleared device (Tina-quant Albumin Gen.2 - cobas c 501 urine assay, K101203).
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 document doesn't explicitly state "acceptance criteria" in a separate section. Instead, performance characteristics of the new device (Tina-quant Albumin Gen. 2 - cobas c 311 urine assay) are presented and compared against those of the predicate device (Tina-quant Albumin Gen. 2 - cobas c 501 urine assay) to demonstrate substantial equivalence. The implication is that the performance of the new device aligns sufficiently with the predicate.
Here's a table summarizing the reported device performance, with the understanding that these values are being compared for substantial equivalence and implicitly serve as acceptable performance benchmarks based on the predicate device.
| Feature | Implicit Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (Tina-quant Albumin Gen. 2 - cobas c 311) |
|---|---|---|
| Measuring Range | 12-400 mg/L | 12-200 mg/L |
| Precision (Repeatability) | ||
| - Level 1 (e.g., 30.7 mg/L) | SD = 0.2, CV = 0.8% | Mean = 32.0, SD = 0.2, CV = 0.7% |
| - Level 2 (e.g., 108 mg/L) | SD = 1, CV = 0.7% | Mean = 101, SD = 1, CV = 1.2% |
| - Level 3 (e.g., 14.3 mg/L) | SD = 0.2, CV = 1.6% | Mean = 10.7, SD = 0.2, CV = 2.2% |
| - Level 4 (e.g., 252 mg/L) | SD = 4, CV = 1.6% | Mean = 132, SD = 2, CV = 1.9% |
| Precision (Intermediate Precision) | ||
| - Level 1 (e.g., 31.2 mg/L) | SD = 0.5, CV = 1.7% | Mean = 31.3, SD = 0.6, CV = 1.9% |
| - Level 2 (e.g., 105 mg/L) | SD = 1, CV = 1.2% | Mean = 97.9, SD = 0.7, CV = 0.7% |
| - Level 3 (e.g., 13.6 mg/L) | SD = 0.4, CV = 2.8% | Mean = 13.6, SD = 0.4, CV = 2.9% |
| - Level 4 (e.g., 60.6 mg/L) | SD = 1.4, CV = 2.3% | Mean = 63.7, SD = 0.7, CV = 1.1% |
| Analytical Sensitivity | ||
| - Limit of Blank (LoB) | 2 mg/L | 2 mg/L |
| - Limit of Detection (LoD) | 3 mg/L | 3 mg/L |
| - Limit of Quantitation (LoQ) | 12 mg/L | 12 mg/L |
| Analytical Specificity | No interference at therapeutic concentrations; no false result without flag up to 40000 mg/L Albumin | No interference at therapeutic concentrations; no false result without flag up to 40000 mg/L Albumin |
| Interferences | Recovery within ± 10% (for icterus, hemolysis, certain substances) | Recovery within ± 10% (for icterus, hemolysis, certain substances) |
| Method Comparison | Linear regression: y = 1.038x - 1.066 mg/L, r = 0.999 | Passing Bablock: y = 1.036x + 0.415 mg/L, $\tau$ = 0.972 |
Note: For many features (Assay Protocol, Sample Type, Calibrator, Calibration Frequency, Controls, Reagent Stability, Analytical Specificity, and Interferences), the predicate device's performance implicitly serves as the acceptance criterion, and the new device is stated to be "Same" or to have met the same criteria.
The measuring range of the new device (12-200 mg/L) is narrower than the predicate (12-400 mg/L), but this difference is not flagged as a concern for substantial equivalence in the document.
2. Sample Size Used for the Test Set and Data Provenance:
-
Method Comparison:
- Sample Size: n = 69
- Data Provenance: Not explicitly stated (e.g., country of origin). The document states "human urine samples," but does not specify if they were collected retrospectively or prospectively.
-
Precision (Repeatability & Intermediate Precision): The sample sizes for these studies are not explicitly stated, nor is the data provenance. Usually, these involve multiple runs and replicates of control or spiked samples.
-
Analytical Sensitivity, Specificity, and Interferences: Sample sizes and data provenance are not provided for these studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. The studies performed (method comparison, precision, analytical sensitivity, specificity, interferences) are laboratory-based and involve technical measurements rather than interpretations by medical experts for establishing ground truth in the traditional sense of diagnostic imaging or clinical decision-making.
4. Adjudication Method for the Test Set:
This information is not applicable or not provided. The studies detailed are analytical performance studies of a laboratory assay, not studies requiring expert adjudication methods like 2+1 or 3+1 that are common in diagnostic imaging or clinical studies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of Human Readers Improvement with AI vs. Without AI Assistance:
This information is not applicable. The device is an in vitro diagnostic assay (a laboratory test) and does not involve human readers interpreting images or data that would be assisted by AI. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:
This information is not applicable in the context of AI. The device itself is an automated immunoturbidimetric assay on an instrument (cobas c 311). Its performance, as described by precision, sensitivity, specificity, and method comparison, represents the "standalone" or "algorithm only" performance of the assay on the instrument without human interpretation of raw data. There is no AI component that would require a separate "human-in-the-loop" study.
7. The Type of Ground Truth Used:
- Method Comparison: The "ground truth" for the method comparison study is implicitly the measurement obtained from the predicate device (Tina-quant Albumin Gen. 2 - cobas c 501 assay, K101203). The study compares the new device's results against the predicate device's results.
- Precision: Ground truth is established by the known concentrations of control or spiked samples used in the precision studies.
- Analytical Sensitivity: Ground truth for LoB, LoD, and LoQ is determined through statistical analysis of blank and low-concentration samples.
- Analytical Specificity and Interferences: Ground truth is established by known concentrations of interfering substances added to samples, and observing the recovery of the albumin measurement.
8. The Sample Size for the Training Set:
This information is not provided and is not applicable in the context of this device. The Tina-quant Albumin Gen. 2 Assay is a chemical/immunological assay, not a machine learning or AI-based device that requires a "training set." The assay relies on established chemical reactions and optical detection, not an algorithm that learns from data.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable for the reasons stated in point 8.
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(450 days)
DCF
The EasyRA µALB reagent is intended for the quantitative determination of micro-albumin in human urine, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Micro-albumin measurements using immunological tests aid in the diagnosis of kidney diseases.
The EasyRA micro-albumin (µALB) calibrator facilitates measurements of µALB on the EasyRA clinical chemistry analyzer when used in conjunction with Medica's µALB reagent. The µALB calibrator is used to establish points of reference that are used in the determination of values in the measurement of µALB in human urine.
Not Found
The provided text is a 510(k) summary for a medical device called "EasyRA micro-albumin (uALB) Reagent and EasyRA microalbumin (uALB) Calibrator." It describes the intended use of the device and confirms its substantial equivalence to predicate devices. However, this document does not contain any information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is primarily a regulatory clearance letter.
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(134 days)
DCF
The Tina-quant Albumin Gen. 2 assay is an immunoturbidimetric assay intended for the quantitative determination of albumin in serum, plasma, urine, and CSF on Roche/Hitachi cobas c systems. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.
The Tina-quant Albumin Gen. 2 assay employs an immunoturbidimetric test in which anti-albumin antibodies react with the antigen in the sample to form antigen/antibody complexes which, following agglutination are determined turbidimetrically.
The provided document describes the Tina-quant Albumin Gen. 2 assay, an immunoturbidimetric test for quantitative determination of albumin in human urine, serum, plasma and CSF on Roche/Hitachi cobas c systems.
Here's an analysis of the acceptance criteria and the studies performed, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents separate substantial equivalence comparisons for the urine, serum/plasma, and CSF applications of the Tina-quant Albumin Gen. 2 assay against predicate devices. The "acceptance criteria" are implied by the measured performance parameters, as they are being compared to the predicate device and found to be substantially equivalent.
Table 1: Urine Application Performance Comparison
| Feature | Acceptance Criteria (Predicate: Hitachi Microalbumin Urine Assay - K932950) | Reported Device Performance (Tina-quant Albumin Gen. 2 - Urine Application) |
|---|---|---|
| Precision | ||
| Within-run (mg/L) | Mean = 9.0, SD = 0.29, CV = 3.2% | Mean = 30.7, SD = 0.2, CV = 0.8% |
| Mean = 22.1, SD = 0.30, CV = 1.4% | Mean = 108, SD = 1, CV = 0.7% | |
| Mean = 81.1, SD = 0.67, CV = 0.8% | Mean = 14.3, SD = 0.2, CV = 1.6% | |
| Mean = 252 mg/L, SD = 4, CV = 1.6% | ||
| Total (mg/L) | Mean = 9.0, SD = 0.92, CV = 10.1% | Mean = 31.2, SD = 0.5, CV = 1.7% |
| Mean = 22.1, SD = 1.15, CV = 5.2% | Mean = 105, SD = 1, CV = 1.2% | |
| Mean = 81.1, SD = 0.78, CV = 1.0% | Mean = 13.6, SD = 0.4, CV = 2.8% | |
| Mean = 60.6, SD = 1.4, CV = 2.3% | ||
| Analytical Sensitivity | Lower Detection Limit = 3 mg/L | LoB = 2 mg/L, LoD = 3 mg/L, LoQ = 12 mg/L |
| Analytical Specificity | No interference from 18 common drugs | No interference at common therapeutic concentrations |
| No unflagged high-dose hook effect up to 40000 mg/L | ||
| Interferences | Criterion: Recovery within ± 10% | |
| Icterus | No significant interference up to 25 mg/dL | No significant interference up to I index of 50 (approx. 50 mg/dL conjugated bilirubin) |
| Hemolysis | Hemoglobin levels >300 mg/dL cause significant positive interference | No significant interference up to H index of 400 (approx. 400 mg/dL hemoglobin) |
| Lipemia | No significant interference up to an L index of 200 | No interference by acetone, ammonia chloride, calcium, creatinine, y-globulin, glucose, urea, uric acid, urobilinogen (specific concentrations given) |
| Method Comparison | Linear Regression: y = 1.028x - 4.13 mg/L, r = 0.999 | Passing Bablock: y = 1.023x + 3.64 mg/L, $\tau$ = 0.984 |
| (Predicate on Hitachi 917 analyzer) | (Tina-quant on c501 analyzer vs. Hitachi Microalbumin on Hitachi 917) |
Table 2: Serum/Plasma Application Performance Comparison
| Feature | Acceptance Criteria (Predicate: Behring N Antiserum to Human Albumin Assay - K972929) | Reported Device Performance (Tina-quant Albumin Gen. 2 - Serum/Plasma Application) |
|---|---|---|
| Precision | ||
| Intra-assay (g/L) | Mean: 46.5; CV: 4.3% | |
| Inter-assay (g/L) | Mean: 44.7; CV: 4.4% | |
| Repeatability (Within-run) (mg/L) | Not directly comparable, but predicate shows ~4% CV | Mean = 39.9, SD = 0.5, CV = 1.2% |
| Mean = 66.6, SD = 1.4, CV = 1.2% | ||
| Mean = 27.6, SD = 0.4, CV = 1.3% | ||
| Mean = 62.5 mg/L, SD = 0.9, CV = 1.5% | ||
| Intermediate Precision (Total) (mg/L) | Not directly comparable, but predicate shows ~4% CV | Mean = 42.3, SD = 0.9, CV = 2.0% |
| Mean = 70.5, SD = 1.6, CV = 2.2% | ||
| Mean = 7.78, SD = 0.74, CV = 9.5% | ||
| Mean = 36.2, SD = 0.7, CV = 2.1% | ||
| Analytical Sensitivity | Established by lower limit of reference curve, depends on protein concentrations | LoB = 1 g/dL, LoD = 2 g/dL, LoQ = 3 g/dL |
| Analytical Specificity | No interference from commonly used drugs is known. | No interference at common therapeutic concentrations |
| Interferences | Turbidity and particles may interfere. Bovine serum albumin may disturb. | Criterion: Recovery within ± 10% |
| Icterus | Not specified in detail, but general interference noted. | No significant interference up to I index of 60 (approx. 60 mg/dL conjugated bilirubin) |
| Hemolysis | Not specified in detail, but general interference noted. | No significant interference up to H index of 1000 (approx. 1000 mg/dL hemoglobin) |
| Lipemia | Not specified in detail, but general interference noted. | No significant interference up to L index of 1500 (approx. 1500 mg/dL intralipid) |
| Rheumatoid factors | Not specified. | ≤ 1200 IU/mL do not interfere. |
| Method Comparison | Predicate calibrates by serial dilutions | Passing Bablock: y = -0.1320 + 0.9600x, $\tau$ = 0.919 |
| Linear Regression (provided): y = -0.0095 + 0.9572x, r = 0.993 | ||
| (Tina-quant on c501 analyzer vs. nephelometric Albumin test) | (Tina-quant on c501 analyzer vs. nephelometric Albumin test) |
Table 3: CSF Application Performance Comparison
| Feature | Acceptance Criteria (Predicate: Behring N Antiserum to Human Albumin Assay - K972929) | Reported Device Performance (Tina-quant Albumin Gen. 2 - CSF Application) |
|---|---|---|
| Precision | Not specified for CSF in predicate. | |
| Repeatability (Within-run) (mg/L) | Mean = 99.2, SD = 1.4, CV = 1.4% | |
| Mean = 174, SD = 3, CV = 1.7% | ||
| Mean = 383, SD = 4, CV = 1.0% | ||
| Mean = 454 mg/L, SD = 4, CV = 0.8% | ||
| Intermediate Precision (Total) (mg/L) | Mean = 91.0, SD = 2.9, CV = 3.2% | |
| Mean = 389, SD = 7, CV = 1.7% | ||
| Mean = 166, SD = 4, CV = 2.3% | ||
| Mean = 366, SD = 5, CV = 1.3% | ||
| Analytical Sensitivity | Established by lower limit of reference curve, depends on protein concentrations | LoB = 20 mg/L, LoD = 36 mg/L, LoQ = 95 mg/L |
| Analytical Specificity | No interference from commonly used drugs is known. | No interference at common therapeutic concentrations |
| Interferences | Not specified for CSF. | Criterion: Recovery within ± 10% |
| Hemolysis | No significant interference up to H index of 1000 (approx. 1000 mg/dL hemoglobin) | |
| Icterus | No significant interference up to I index 60 (approx. 600 mg/L conjugated and unconjugated bilirubin) | |
| High dose hook-effect | No false result without a flag up to 30000 mg/L albumin concentration | |
| Method Comparison | Predicate calibrates by serial dilutions. | Passing Bablock: y = 1.000x - 8.75 mg/L, $\tau$ = 0.936 |
| Linear Regression (provided): y = 0.991x + 0.301 mg/L, r = 0.992 | ||
| (Tina-quant on c501 analyzer vs. nephelometric Albumin test) | (Tina-quant on c501 analyzer vs. nephelometric Albumin test) |
2. Sample Size Used for the Test Set and Data Provenance
-
Urine Application Method Comparison:
- Sample Size: n = 125
- Provenance: Not explicitly stated (e.g., country of origin, prospective/retrospective). The comparison is between the Tina-quant Albumin Gen. 2 assay on the c501 analyzer and the Hitachi Microalbumin assay on the Hitachi 917 analyzer (K953239). The sample concentrations were between 12.3 and 386 mg/L.
-
Serum/Plasma Application Method Comparison:
- Sample Size: n = 77
- Provenance: Not explicitly stated. The comparison is between the Tina-quant Albumin Gen. 2 assay on the cobas c501 analyzer and a nephelometric Albumin test. The sample concentrations were between 5.70 and 100 g/L.
-
CSF Application Method Comparison:
- Sample Size: n = 85
- Provenance: Not explicitly stated. The comparison is between the Tina-quant Albumin Gen. 2 assay on the cobas c501 analyzer and a nephelometric Albumin test. The sample concentrations were between 115 and 2640 mg/L.
-
Precision, Sensitivity, Specificity, Interferences:
- The sample sizes for these internal studies are not explicitly mentioned in the provided text for each specific test, but they are implied to be sufficient for analytical validation. Provenance is also not explicitly stated.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
- The document describes an in-vitro diagnostic device for quantitative determination of albumin. The "ground truth" here is the actual albumin concentration in the samples, established by reference methods or predicate devices, rather than expert interpretation of images or other subjective data.
- Therefore, the concept of "experts" to establish a subjective ground truth (like radiologists for imaging) is not directly applicable to this type of analytical device. The references are to other cleared devices (predicate devices) or established analytical methods.
4. Adjudication Method for the Test Set
- As the device provides a quantitative measurement, and the "ground truth" is established by a reference method or predicate device performance, there is no mention of an "adjudication method" in the sense of reconciling differences between multiple human interpreters. This concept is typically relevant for subjective assessments (e.g., medical image interpretation).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done. This type of study is relevant for devices that assist human readers (e.g., AI in radiology). The Tina-quant Albumin Gen. 2 assay is a standalone diagnostic test performed by an automated analyzer, not an assistive technology for human interpreters.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
- Yes, the performance data presented is for the standalone device (Tina-quant Albumin Gen. 2 assay on the Roche/Hitachi cobas c systems) without human intervention for the measurement itself. The results are quantitative values generated by the automated system. The accuracy is assessed by correlation with predicate devices/methods.
7. The Type of Ground Truth Used
- The ground truth for the performance studies (specifically method comparisons) was established by comparison to existing, legally marketed predicate devices or established nephelometric albumin tests. This implies that the predicate devices/methods themselves served as the reference standard for the "true" albumin values in the samples.
8. The Sample Size for the Training Set
- The document describes a 510(k) submission for substantial equivalence. This is for a conventional in-vitro diagnostic (IVD) assay, not a machine learning or AI-based device that typically involves "training sets." Therefore, the concept of a "training set" in the context of machine learning is not applicable here. The assay relies on established immunoturbidimetric principles, and performance is validated through analytical studies on test samples.
9. How the Ground Truth for the Training Set Was Established
- As explained in point 8, the concept of a "training set" is not applicable to this device submission.
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The cobas 8000 Modular Analyzer Series is a fully automated system for clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit. It is intended for use in conjunction with certain materials to measure a variety of analytes that may bbe adaptable to the below analyzers depending on the reagents used.
The cobas c701 analyzer is a fully automated, discrete clinical chemistry analyzer intended for the in vitro quantitative / qualitative determination of analytes in body fluids.
The cobas c502 analyzer is a fully automated discrete clinical chemistry analyzer intended for the in vitro quantitative / qualitative determination of analytes in body fluids.
The cobas 8000 ISE module is a fully automated ion- specific analyzer intended for the in vitro potentiometric determination of chloride, potassium and sodium in serum and plasma using ion-selective electrodes. Measurements obtained by this device are used in the diagnosis and treatment of diseases or conditions involving electrolyte imbalance.
IGA-2 is an in vitro test for the quantitative determination of IgA in human serum and plasma on Roche/Hitachi cobas c systems. IgA measurements aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
The cobas 8000 Modular Analyzer Series is a fully automated system for clinical chemistry analysis intended for the in vitro quantitative/qualitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (cobas 8000 ISE module) and photometric analysis modules (cobas c 701 and c 502 modules). The cobas c 701 and c 502 analyzer modules are new members of the Roche / Hitachi family of clinical chemistry analyzers.
The cobas 8000 ISE module is an Ion-selective electrode system for the determination of sodium, potassium and chloride in serum and plasma.
The cobas c 701 module is a fully automated, discreet, computerized instrument for in vitro tests on a wide range of analytes. It is designed to use serum/plasma, urine, CSF supernatant and whole blood sample types. The related sample buffer module offers a random access buffer function for samples.
The cobas c 502 module is analytically identical to the cobas c 501 module (cobas 6000 analyzer series. K060373), but without an integrated ISE module. The related sample buffer module offers a random access buffer function for samples.
The cobas 8000 Data Manager acts as a command/control center between the cobas 8000 instrument and the LIS. The data manager software is installed on a PC. It also provides enhanced sample tracking, test management, result traceability, storage and reporting, quality control and calibration management, has LIS backup functionality and serves as a robust storage location for the instrument.
The control unit uses a graphical user interface to control all instrument functions, and is comprised of a touch screen monitor, keyboard and mouse and a personal computer.
The core unit is comprised of several components that manage conveyance of samples to each assigned analytical module. The actual composition of the core unit depends on the configuration of the analytical modules. Features of the Core Unit include a barcode reader (for racks and samples), automatic tube position if barcode position is misaligned, system power switch and circuit breaker, the sample rack loader/unloader, a STAT port, a water supply and a system interface port.
The Roche cobas 8000 Modular Analyzer Series is a fully automated system for clinical chemistry analysis. The submission focuses on modifications to the predicate device (cobas 6000 Analyzer Series).
1. Acceptance Criteria and Reported Device Performance
The device's performance was evaluated through application testing based on a risk analysis. While specific quantitative acceptance criteria are not explicitly detailed for each test, the general statement is that "All testing met specifications." This implies that the observed performance was acceptable for each parameter.
Here’s a table summarizing the tests and the reported performance (where available):
| Test Type | Analyte(s) Tested | Reported Device Performance |
|---|---|---|
| In-run Precision | IgA, Sodium, Potassium, Chloride | Met specifications |
| Between-day Precision | IgA, Sodium, Potassium, Chloride | Met specifications |
| Linearity | IgA, Sodium, Potassium, Chloride | Met specifications |
| Recovery of Controls | IgA, Sodium, Potassium, Chloride | Met specifications |
| Method Comparison | IgA (compared to c501) | Met specifications |
| Method Comparison | Sodium, Potassium (compared to c501 and flame) | Met specifications |
| Method Comparison | Chloride (compared to c501 and coulometry) | Met specifications |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample sizes used for the test set. However, it mentions that "application testing done on the cobas c701 and c502, using IgA as a representative assay," and that Sodium, Potassium, and Chloride were also tested.
The data provenance (country of origin, retrospective or prospective) is not specified. However, given that it's a submission to the FDA, the testing would likely have been conducted in a controlled, prospective manner to evaluate the new device's performance, potentially at Roche Diagnostics development sites or clinical study sites.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document. The type of ground truth used is clinical measurements from established methods (predicate device, flame photometry for Sodium/Potassium, coulometry for Chloride). The interpretation of "ground truth" in this context refers to the values obtained from these established reference methods, rather than expert consensus on diagnostic images or clinical outcomes.
4. Adjudication Method for the Test Set
This information is not applicable/provided as the study involves analytical performance comparison rather than subjective assessment needing adjudication (like image interpretation). The "ground truth" is based on instrument readings from established methods.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not performed as this device is a chemistry analyzer and its performance is assessed by analytical accuracy and precision, not by human reader interpretation of results.
6. Standalone (Algorithm Only) Performance
This entire submission describes the standalone performance of the instrument. The cobas 8000 Modular Analyzer Series is an automated system designed to run without human intervention during the analytical process, once samples and reagents are loaded. The results are generated by the algorithm/instrument directly.
7. Type of Ground Truth Used
The ground truth for the test set was established using recognized reference methods and performance of the predicate device:
- For IgA: Method comparison was performed against the cobas c501 (predicate device).
- For Sodium, Potassium: Method comparison was performed against the cobas c501 (predicate device) and flame photometry. Flame photometry is a well-established analytical technique for determining the concentration of certain metal ions.
- For Chloride: Method comparison was performed against the cobas c501 (predicate device) and coulometry. Coulometry is a precise electroanalytical technique used for quantitative determination of substances.
These are considered objective, analytical measurements from established laboratory techniques.
8. Sample Size for the Training Set
The document does not provide information regarding a specific "training set" or its sample size. This type of device (clinical chemistry analyzer) is typically developed and validated against established analytical principles and reference methods, rather than being "trained" on a dataset in the way a machine learning algorithm would be. The "training" in this context would implicitly refer to the development and optimization process based on chemical and physical principles, rather than an explicit dataset.
9. How the Ground Truth for the Training Set was Established
As no explicit training set is mentioned in the context of machine learning, the concept of "ground truth for the training set" as it would apply to AI is not applicable. The development and "training" of this device would involve engineering, chemical, and physical principles, with performance validated against known standards, calibrators, and reference methods as described in point 7.
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The K-ASSAY® Microalbumin reagent is for the quantitative determination of human albumin in urine by immunoturbidimetric assay. Measurement of albumin in urine nids in the diagnosis of kidney dysfunction. FOR IN VITRO DIAGNOSTIC USE.
K-ASSAY ® The Microalbumin Calibrator is for the calibration of the K-ASSAY® Microalbumin assay for quantifying albumin in urine speiment. FOR IN VITRO DIAGNOSTIC USE.
Not Found
This document is a 510(k) premarket notification approval letter from the FDA for a medical device called "K-Assay® Microalbumin" and "K-Assay® Microalbumin Calibrator". This type of document typically confirms that a new device is "substantially equivalent" to an already legally marketed device, but it does not specify acceptance criteria or detailed study results.
Therefore, the requested information about acceptance criteria and the study proving the device meets them cannot be extracted from the provided text. The document primarily focuses on regulatory approval and classification rather than performance metrics.
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MA reagent, when used in conjunction with SYNCHRON CX® System(s) and SYNCHRON CX® MA Calibrator, is intended for the quantitative determination of albumin (MA) concentration in human urine. Measurement of albumin in urine aids in the diagnosis of kidney dysfunction.
Synchron Systems Microalbumin (MA) reagent is intended for the quantitative determination of albumin in urine. MA reagent is used to measure the albumin concentration by a turbidimetric method. In the reaction, albumin combines with specific antibody to form insoluble antigen-antibody complexes. The Synchron System(s) automatically proportions the appropriate sample and reagent volumes into the cuvette. The ratio used is one part sample to 24 parts reagent. The system monitors the change in absorbance at 380 nanometers. This change in absorbance is proportional to the concentration of albumin in the sample and is used by the system to calculate and express albumin concentration based upon a non-linear calibration curve.
Here's a breakdown of the acceptance criteria and study information for the SYNCHRON® Systems Microalbumin (MA) Reagent, based on the provided text:
Acceptance Criteria and Device Performance
The provided document describes performance characteristics rather than explicit acceptance criteria with pre-defined thresholds. However, we can infer the desired performance from the reported results and the comparison to the predicate device. The study aims to demonstrate substantial equivalence to the predicate.
| Performance Metric | Acceptance Criteria (Inferred) | Reported Device Performance (SYNCHRON® Systems MA Reagent) |
|---|---|---|
| Method Comparison (Correlation with Predicate) | High correlation (R close to 1), slope close to 1, intercept close to 0 with the predicate. | Slope: 0.990 |
| Intercept: -0.11 | ||
| R: 0.987 | ||
| Within-Run Precision (CV) | Low coefficient of variation (CV) at different concentration levels. | Level 1 (0.8 mg/dL): 9.7% |
| Level 2 (3.0 mg/dL): 4.5% | ||
| Level 3 (40.1 mg/dL): 1.0% | ||
| Total Precision (CV) | Low coefficient of variation (CV) across multiple runs and days. | Level 1 (0.8 mg/dL): 16.3% |
| Level 2 (3.0 mg/dL): 7.5% | ||
| Level 3 (40.1 mg/dL): 1.5% | ||
| Measuring Range (Initial) | Wider or comparable to predicate. | 0.2 - 30 mg/dL (Predicate: 0.2 - 4.0 mg/dL) |
| Measuring Range (Extended) | Wider or comparable to predicate, with effective extension methods. | 24 - 97 mg/dL (achieved via smaller sample size) (Predicate: 4.0 - 864.0 mg/dL via on-line dilutions) |
Study Information
2. Sample Size Used for the Test Set and Data Provenance:
- Method Comparison (N): 111 (samples)
- Precision Studies (N): 80 (measurements per level for both within-run and total imprecision)
- Data Provenance: Not explicitly stated (e.g., country of origin). The document implies these are laboratory-generated data for performance validation. It is retrospective in the sense that the data used to prove substantial equivalence was collected prior to the 510(k) submission.
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 quantitative diagnostic test for a chemical analyte (albumin). The "ground truth" for the test set is established by the reference method (predicate device measurements) and the intrinsic chemical properties/concentrations of the samples used in the precision studies, not by expert interpretation.
4. Adjudication Method for the Test Set:
- Not applicable. See point 3.
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 reagent for an automated laboratory instrument, not an AI-assisted diagnostic tool that involves human readers/interpreters in the diagnostic process.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance study was done. The entire performance evaluation (method comparison, precision data) for the SYNCHRON® Systems Microalbumin (MA) Reagent is a standalone evaluation of the device's analytical performance on the SYNCHRON CX® System, without human interpretation as part of the primary measurement.
7. The Type of Ground Truth Used:
- Reference Method/Quantitative Measurement: For the method comparison, the "ground truth" is the quantitative measurement provided by the legally marketed predicate device (IMMAGE Microalbumin (MA) Reagent). For precision, the "ground truth" for each sample level is its mean concentration as determined by repeated measurements.
8. The Sample Size for the Training Set:
- Not explicitly stated in terms of a separate "training set" for an algorithm. For this type of device (chemical reagent for an automated system), "training" generally refers to the development and optimization of the reagent formulation and the instrument's calibration curve. The document mentions a "6 level non-linear calibration curve" for the Synchron CX systems, which suggests calibration data were used to establish the assay's operational parameters, but the specific sample size for this is not provided.
9. How the Ground Truth for the Training Set was Established:
- Not explicitly detailed as a distinct "ground truth" for a training set. The calibration curve construction (mentioned as "6 level non-linear calibration curve") would involve using calibrator materials with known, accurately determined concentrations of albumin. These concentrations would be established through a traceable reference method or gravimetric preparation.
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