Search Results

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

Ask a specific question about this device

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:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and data provenance
3. Number of experts and qualifications for ground truth
4. Adjudication method
5. MRMC comparative effectiveness study results
6. Standalone performance results
7. Type of ground truth used
8. Sample size for the training set
9. 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.

Ask a specific question about this device

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.

• 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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

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.

Ask a specific question about this device

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

Table 2: Serum/Plasma Application Performance Comparison

Table 3: CSF Application Performance Comparison

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.
  • For urine, the predicate was the Hitachi Microalbumin urine assay (K932950).
  • For serum/plasma and CSF, the predicate was the Behring Nephelometric method (K972929).

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.

Ask a specific question about this device

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.

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.

Ask a specific question about this device

Afinion™ ACR is an in vitro diagnostic test for quantitative determination of albumin, creatinine and albumin/creatinine ratio (ACR) in human urine. The measurement of urine albumin, creatinine and albumin/creatinine ratio aids in the early diagnosis of nephropathy.

Afinion™ ACR Control is a assayed in vitro diagnostic quality control material used to confirm that the Afinion™ ACR and the Afinion™ AS100 Analyzer System is working properly and provides reliable results

The Afinion™ ACR assay is an in vitro diagnostic test for quantitative determination of albumin, creatinine and albumin/creatinine ratio (ACR) in human urine using the Afinion™ AS100 Analyzer. The measure of urine albumin aids in the early diagnosis of nephropathy.

The Afinion™ ACR Control kit contains liquid preparations of albumin and creatinine in citrate buffer. The controls should be used to confirm that the Afinion™ AS100 Analyzer System is working properly and provides reliable results.

Afinion™ ACR is a fully automated assay for determination of albumin, creatinine and albumin/creatinine ratio (ACR) in human urine.

The Afinion™ ACR Test Cartridge contains all the reagents necessary for determining albumin, creatinine and ACR in a human urine sample. The sample material is sampled using the sampling device integrated into the Test Cartridge.

Albumin is quantified using a solid phase immunochemical assay. In the Afinion™ ACR Test Cartridge the sample is automatically diluted and aspirated through a membrane coated with antialbumin antibodies, which concentrates and immobilizes the albumin from the sample. A goldantibody conjugate then binds to the immobilized albumin resulting in a red-brown stained membrane. Excess gold-antibody conjugate is removed in a washing step. The Afinion™ AS100 Analyzer measures the color intensity of the membrane, which is proportional to the amount of albumin in the sample.

Creatinine is quantified using an enzymatic colorimetric test that involves four enzymatic steps. The test requires incubation with two distinct enzyme solutions. A colored end product is measured in one of the cartridge wells.

The concentration of albumin, the concentration of creatinine, and the calculated albumin/creatinine ratio are displayed on the Afinion™ AS100 Analyzer.

Acceptance Criteria and Study Details for Afinion™ ACR

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Afinion™ ACR assay were implicitly established through its comparison to a legally marketed predicate device, the DCA 2000® Microalbumin/Creatinine assay (K963142). The goal was to demonstrate "substantial equivalence" in performance. While explicit numerical acceptance criteria were not provided in terms of thresholds for correlation coefficients or precision values, the reported device performance, demonstrating strong correlation and acceptable precision, was considered sufficient to meet the equivalence standard.

2. Sample Size and Data Provenance

• Test Set (Method Comparison - External Study):

  • Sample Size: 169 urine samples
  • Data Provenance: Studies were conducted at "four external study sites." The specific country of origin is not explicitly stated, but the submission is from Norway, hence it's likely European or international. The samples were retrospective, as they were "analyzed" with both devices.

• Test Set (Method Comparison - Internal Study):

  • Sample Size: 91 urine samples for Albumin and ACR, 95 urine samples for Creatinine.
  • Data Provenance: "Internal method comparison study," implying the data originated from the manufacturer's own facilities. These were retrospective samples.

• Test Set (Precision Study):

  • Sample Size: Not explicitly stated as a number of unique patient samples for the clinical precision study. Instead, it refers to "two levels of urine samples" (Sample 1 and Sample 2) run multiple times. For the control precision, controls were run in "6 replicates each day over 5 operating days."
  • Data Provenance: "External precision study" and "3 study sites" for controls.

3. Number of Experts and Qualifications for Ground Truth

The study relies on comparing the performance of the new device against a predicate device (DCA 2000® Microalbumin/Creatinine assay). Therefore, the "ground truth" for the test set is effectively the result obtained from the predicate device. No human experts were used to establish a separate, independent ground truth for the test samples in this specific type of comparison study. The predicate device itself acts as the reference standard.

4. Adjudication Method

Not applicable. Since the ground truth for comparison was the result from a predicate device, and the study focused on quantitative correlation and precision, there was no need for expert adjudication of results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission is for an in vitro diagnostic (IVD) device, specifically an automated assay for quantitative measurement. This type of study is more common for imaging devices or those requiring human interpretation of results. The study design focuses on the analytical performance (accuracy, precision) of the device itself compared to a predicate device, not on how human readers' diagnostic performance might improve with or without AI assistance.

6. Standalone (Algorithm Only) Performance

Yes, the study describes the standalone performance of the Afinion™ ACR assay. It is an "automated assay" that "quantifies" albumin and creatinine, and "calculates" the ACR. The performance metrics (correlation coefficients, precision) presented are solely based on the device's measurements from urine samples, without human intervention in the result generation or interpretation to modify the output.

7. Type of Ground Truth Used

The "ground truth" used for evaluating the Afinion™ ACR assay was the results obtained from a legally marketed predicate device, the DCA 2000® Microalbumin/Creatinine assay (K963142). This is a common approach for demonstrating substantial equivalence for in vitro diagnostic devices. It relies on the established accuracy and reliability of the predicate.

8. Sample Size for the Training Set

The document does not explicitly mention a separate "training set" or its sample size in the context of device development. For IVD assays, development often involves extensive internal testing, calibration, and optimization using various samples, but this is usually distinct from the formal "training set" concept seen in AI/machine learning development.

9. How Ground Truth for the Training Set was Established

Given that this is an in vitro diagnostic assay and not a machine learning algorithm in the typical sense, there isn't a "training set" with ground truth established in the way one would for an AI model.

The "standardization" section states that:

• Albumin is calibrated against the ERM®-DA470 reference preparation.
• Creatinine is calibrated against SRM 914a.

These reference materials serve as the foundational "ground truth" for the device's calibration, ensuring that its measurements are traceable to recognized international standards. This calibration process, along with extensive internal testing and optimization (which would involve numerous samples with known values, likely determined through reference methods or predicate devices), forms the basis of the device's accuracy.

Ask a specific question about this device

Proteins reagents, with associated calibrators and controls, are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer to measure a variety of analytes.

ABX PENTRA Albumin CP reagent, with associated calibrators and controls, is a diagnostic reagent for quantitative determination of Albumin in serum and plasma by colorimetry.

Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

ABX PENTRA Total Protein CP reagent, with associated calibrators and controls, is a diagnostic reagent for quantitative in-vitro determination of Total Proteins in serum and plasma by colorimetry.

Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.

ABX PENTRA Micro-albumin CP reagent, with associated calibrators and controls, is a diagnostic reagent for quantitative in-vitro determination of Albumin in urine (µALB) at low concentration by immunoturbidimetric assay.

Measurements of albumin aids in the diagnosis of diabetic nephritis and other kidney and intestinal diseases.

The ABX PENTRA µ-Alb Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA Micro-albumin CP method on Horiba ABX clinical chemistry analyzers.

The ABX PENTRA u-Alb Control L/H is for use in quality control by monitoring accuracy and precision for the quantitative ABX PENTRA Micro-albumin CP method.

The ABX PENTRA Multical is a calibrator for use in the calibration of quantitative Horiba ABX methods on Horiba ABX clinical chemistry analyzers.

The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision.

The ABX PENTRA P Control is for use in quality control by monitoring accuracy and precision.

All the reagents, controls and calibrators included in this submission are for use on the ABX PENTRA 400 (K052007), which is a discrete photometric benchtop clinical chemistry analyzer.

The ABX PENTRA Albumin CP is an in vitro diagnostic assay for the quantitative determination of albumin in human serum and plasma based on a colorimetric test using Bromocresol Green (BCG). It is composed of a 99 ml mono-reagent cassette.

The ABX PENTRA Total Protein CP is an in vitro diagnostic assay for the quantitative determination of total proteins in human serum and plasma based on a colorimetric test (Biuret reaction). It is composed of a 61 ml mono-reagent cassette.

The ABX PENTRA Multical is a lyophilized human serum calibrator with chemical additives and materials of biological origin. The assigned values of the calibrator components are given in the enclosed annex, ensuring optimal calibration of the appropriate HORIBA ABX methods on the ABX PENTRA 400 analyzer. This calibrator is provided in ten vials of 3 ml.

The ABX PENTRA N Control and ABX PENTRA P Control are quality control products consisting of lyophilized human serum with chemical additives and materials of biological origin added as required to obtain given component levels. The assigned values of the control components are given in the enclosed annexes, ensuring control of the appropriate HORIBA ABX methods on the ABX PENTRA 400 analyzer. Each control is provided in ten vials of 5 ml.

The ABX PENTRA Micro-albumin CP is an in vitro diagnostic assay for the quantitative determination of albumin in human urine based on an immunoturbidimetric test. It is composed of a bi-reagent cassette, with 19 ml and 4.5 ml compartments.

The ABX PENTRA u-Alb Cal is a liquid calibrator prepared by adding purified human albumin to a chemical buffer solution. It has 5 levels to be used for the calibration of the urinary albumin assay. The assigned values are given on the calibrator vials. This calibrator is provided in five vials of 1 ml.

The ABX PENTRA u-Alb Control L/H is a liguid assayed control prepared by adding purified human albumin to a chemical buffer solution. It has 2 levels (Low and High) to be used for the quality control of the urinary albumin assay. The assigned values are given in the enclosed annex. Each level of this calibrator is provided in two vials of 1 ml.

The provided text describes performance data for a set of reagents, controls, and calibrators used with the ABX PENTRA 400 clinical chemistry analyzer. The studies conducted are in vitro diagnostic assay performance evaluations, not studies involving human readers or clinical outcomes in the same way an AI-powered diagnostic device would be evaluated. As such, several requested items (MRMC study, expert ground truth, adjudication methods) are not applicable to this type of submission.

Here's a breakdown of the available information:

Acceptance Criteria and Reported Device Performance

The provided tables summarize the performance characteristics. The document states that "The performance testing data conclude that the safety and effectiveness of the devices are not compromised, and that they met all acceptance criteria, demonstrating that the devices are substantially equivalent to their respective predicate devices." While specific numeric acceptance criteria for each metric (e.g., "CV Total must be

Ask a specific question about this device

NycoCard U-Albumin is intended to measure by immunochemical techniques the albumin (a plasma protein) in urine. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.

NycoCard U-Albumin Control consists of two control materials based on human urine and is intended to be used to confirm the efficacy of the NycoCard U-Albumin reagents and correct performance of the test.

Not Found

The provided text is an FDA 510(k) clearance letter for the NycoCard U-Albumin and NycoCard U-Albumin Control devices. It does not contain the detailed study information required to answer questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or expert qualifications for a study proving device adherence to acceptance criteria.

The document primarily focuses on:

• Device Name: NycoCard U-Albumin and NycoCard U-Albumin Control
• Regulation Number and Name: 21 CFR § 866.5040, Albumin immunological test system
• Regulatory Class: Class II
• Product Code: DCF, JJX
• Indications For Use: To measure albumin in urine by immunochemical techniques, aiding in the diagnosis of kidney and intestinal diseases. The control material confirms the efficacy of reagents and correct test performance.
• FDA Clearance: States that the device is substantially equivalent to legally marketed predicate devices.

Therefore, based only on the provided text, I cannot complete a table of acceptance criteria and reported device performance or answer most of the requested study-specific questions.

The document states FDA's determination of "substantial equivalence" based on "indications for use stated in the enclosure." A full 510(k) submission would contain data demonstrating this equivalence, but that data is not included in the provided snippets.

Ask a specific question about this device