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In vitro test for the quantitative determination of the total protein concentration in urine and cerebral spinal fluid.

Protein measurements in urine are used in the diagnosis and treatment of disease conditions such as renal or heart diseases, or thyroid disorders.

CSF protein measurements are used in the diagnosis and treatment of conditions such as meningitis, brain tumors, and infections of the central nervous systems.

The Total Protein Urine/CSF assay provides quantitative measurement of total protein that is present in human urine and cerebral spinal fluid (CSF). Measurement is accomplished using a turbidimetric method.
Reagents for the COBAS Integra 400 plus analyzer are packaged in a cobas c pack with two bottles labeled with their instrument positioning, Reagent R1 in position B and Reagent SR in position C.
R1 contains Sodium Hydroxide: 677 mmol/L; EDTA-Na: 74 mmol/L
SR contains Benzethonium chloride: 32 mmol/L

Here's an analysis of the acceptance criteria and study findings for the TPUC3 Total Protein Urine/CSF Gen.3 device, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

• Deviation = 5.6% at level 1 (92.5 mg/L total protein)
• Deviation = 9.7% at level 2 (961 mg/L total protein)
  Meets criterion. |
  | Interference by Homogentisic Acid | Deviation ≤ ± 10% | At 1.2 mmol/L homogentisic acid:
• Deviation = 6.8% at level 1 (107 mg/L total protein)
• Deviation = 6.9% at level 2 (1180 mg/L total protein)
  Meets criterion. |
  | High Dose Hook Effect | No false result reported up to a protein concentration of 100 g/L. All samples above the measuring range are flagged. | No false result reported up to a protein concentration of 100 g/L.
  All samples above the measuring range are flagged as either being above the measuring range or above the absorbance limit.
  Meets criterion. |

2. Sample Sizes Used for the Test Set and Data Provenance

• Interference by Radiopaque Media: The test used pooled human urine samples at two different total protein levels. Each level was spiked with 10 dilution steps of Hexabrix and tested in triplicate. The specific number of distinct pooled samples is not stated, but at least two unique pooled samples were used (referred to as "level 1" and "level 2").
• Interference by Homogentisic Acid: The test used the same protocol as for radiopaque media, meaning pooled human urine samples at two different total protein levels, spiked with homogentisic acid, and tested in triplicate at 10 dilution steps.
• High Dose Hook Effect: The test used one pooled human urine sample which was spiked with human Albumin up to 100 g/L, and a dilution series was prepared from this spiked sample. The samples were tested in triplicate.

Data Provenance: The document explicitly states "pooled human urine samples." While it doesn't specify the country of origin, the FDA submission context usually implies data relevant to the US regulatory environment. The studies appear to be prospective as they were specifically designed and conducted to evaluate the device's performance against the defined acceptance criteria.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

This document describes performance studies for an in vitro diagnostic (IVD) device that quantifies total protein. The ground truth for such devices is typically established by:

• Reference methods/materials (e.g., traceable calibrators like NIST SRM-927 mentioned in the similarities section for calibration traceability)
• Known concentrations of interference substances (e.g., Hexabrix, homogentisic acid)
• Known concentrations of the analyte itself (e.g., human Albumin for the hook effect).

Therefore, the ground truth is based on analytical standards and precise spiking of known concentrations, not interpretation by medical experts. No human experts (like radiologists) were involved in establishing the ground truth for these specific performance tests.

4. Adjudication Method for the Test Set

Not applicable. The tests involve quantitative measurements against known spiked concentrations or defined analytical limits. There is no subjective interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This document describes the performance of an IVD analyzer for quantitative protein measurement. MRMC studies are typically performed for diagnostic imaging devices where human readers interpret medical images. This is a standalone device performance study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes. The entire study described focuses on the standalone performance of the TPUC3 Total Protein Urine/CSF Gen.3 assay on the Roche COBAS Integra 400 plus analyzer. It evaluates the device's accuracy in the presence of specific interferents and its response to high analyte concentrations, without any human interpretation of the results being part of the performance evaluation.

7. The Type of Ground Truth Used

The ground truth used for these studies is based on:

• Known (spiked) concentrations of interferents (organically bound iodine from Radiopaque media, homogentisic acid) in pooled human urine.
• Known (spiked) concentrations of the analyte (human Albumin) to assess the high dose hook effect.
• The concentrations of these substances were precisely controlled and quantified.

8. The Sample Size for the Training Set

The document does not provide information on the training set size. This submission is for modifications to an existing device (TPUC3 Total Protein Urine/CSF Gen.3). The described studies are validation/verification tests for these specific modifications related to interference claims and hook effect, not for initial model development or training. IVD devices like this are typically developed through iterative analytical and clinical studies, but information about the "training set" for the underlying chemistry/method is not detailed here.

9. How the Ground Truth for the Training Set Was Established

As no training set information is provided, there is no information on how its ground truth was established. For IVD devices, the initial ground truth for method development (analogous to a training set) would generally involve:

• Certified reference materials.
• Patient samples characterized by established reference methods.
• Spiking studies with known concentrations of analytes and interferents.

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The Total Intact Albumin Assay (also known as the AusAm Microalbumin Plus Urinary Assay) is intended for in vitro diagnostic use in the quantitation of intact albumin in human urine. Measurement of intact albumin with this assay aids in the identification of patients who may warrant further testing for kidney or intestinal disease.

Not Found

The provided text is a 510(k) clearance letter from the FDA for an in vitro diagnostic device (AusAm Total Intact Albumin Assay). This type of document does not typically contain the detailed study information required to answer your specific questions about acceptance criteria, statistical methods, ground truth establishment, or sample sizes for device performance studies.

The letter confirms substantial equivalence to a predicate device but does not present the underlying data or study methodology.

Therefore, I cannot extract the information requested from the provided text. To answer your questions, one would need to access the actual 510(k) submission document or supporting studies.

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The HemoChek Urine Collection Kit is a prescription device intended to collect a urine specimen in midstream or by dipping the absorbent pad in a cup containing urine, contain the specimen, and preserve the specimen after collection and during mailing from the collection area to the laboratory for testing of creatinine and microalbumin concentrations.

The HemoChek Urine Collection Kit is a device used by a person under the supervision of a trained health care professional to obtain a urine specimen midstream or by dipping the absorbent pad in a cup of urine, contain the specimen, and preserve the specimen after collection and during mailing to the laboratory for testing of creatinine and microalbumin concentrations. The device consists of the following:

• A collector pad holder/handle with a collector pad and a protective cover over the pad, contained in a sealed "peel-apart" plastic envelope. The collector pad holder/ handle itself consists of two parts, a collector pad holder and a collector pad slider. The collector pad is held in the holder/handle by a pin in the slider that fits into a hole in the collector pad, and by the holder, which keeps the pad from falling off the pin. The slider has a round indicator port in it. A blue color appears in this indicator port when a sufficient amount of urine has been collected.
• A Specimen Tube with a screw-on lid, containing preservative fluid.
• A clear plastic sealed envelope that contains both of the above items.
• A Patient Identification Card which contains the patient's name, address, Social Security Number, Insurance information, the Doctor's name and a bar-coded label which is peeled off and attached to the Collection Tube after the sample has been taken.
• A set of instructions.
• A zip lock bag into which the Specimen Tube is placed after the sample has been taken.
• A mailer into which the zip lock bag is placed.
• A polyethylene mailing envelope which contains all of the above items and is used to mail the HemoChek Urine Collection Kit to the patient.

The provided text describes a 510(k) summary for the HemoChek Urine Collection Kit, a device intended for collecting and preserving urine specimens for laboratory testing of creatinine and microalbumin concentrations.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or a detailed table of exact performance metrics. Instead, the "Summary of Device Testing" section provides a qualitative statement about the device's performance relative to preserved urine.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify the exact sample size ("number of urine pools" or "number of specimens") used for the testing. It vaguely states: "several tests were conducted from the same urine pool".
• Data Provenance: The document does not provide information on the country of origin of the data or whether the study was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention the involvement of experts to establish a "ground truth" in the context of clinical interpretation or diagnosis. The "ground truth" in this study refers to the chemical concentrations of creatinine and microalbumin in urine specimens. This "ground truth" would be established by laboratory analysis using validated assays on both HemoChek collected samples and comparator (preserved and unpreserved) urine samples. It is implied that standard laboratory practices and accredited testing methods were used to determine these concentrations, but details about the specific laboratory or personnel qualifications are not provided.

4. Adjudication Method for the Test Set

Not applicable. This study focuses on the analytical performance of the collection and preservation method for specific biochemical markers, not on the interpretation of medical images or diagnostic decisions that would typically require an adjudication method among experts.

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

No. An MRMC study is typically used to assess the impact of an AI algorithm on human reader performance for tasks like diagnosis or detection. This document describes the evaluation of a physical urine collection and preservation device, not an AI algorithm, and therefore an MRMC study is not relevant or mentioned.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical urine collection kit, not an algorithm. The "standalone performance" in this context refers to the device's ability to collect and preserve urine specimens such that the analytes within remain stable for subsequent laboratory testing, which is implicitly what the "Summary of Device Testing" addresses.

7. Type of Ground Truth Used

The ground truth used was laboratory analytical results for creatinine and microalbumin concentrations. The comparison was made between:

• Specimens collected with the HemoChek device
• Preserved urine specimens (presumably collected using a standard, established preservation method)
• Unpreserved urine specimens (presumably tested immediately or under controlled conditions)

The "ground truth" for the HemoChek device's performance was its ability to yield "substantially the same results" as these comparator samples.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device (urine collection kit), not a machine learning model or algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

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Microalbuminurea has been shown to predict the development of clinically significant nephropathy in diabetic patients. This Urinary Microalbumin Assay Kit is an in vitro immunoturbidimetric test for the quantitative determination of the native, immunoreactive albumin present in human urine.

EnZIP IMMUNOTURBIDIMETRIC URINARY MICROALBUMIN KIT

The provided text does not contain information regarding acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details. The document is an FDA 510(k) clearance letter for the "Immunoturbidimetric Urinary Microalbumin Assay Kit," dating back to 1997. It primarily focuses on the regulatory approval, indicating that the device is substantially equivalent to previously marketed devices.

The only relevant information related to the device is its intended use, as stated in the "Indications for Use" section:

• Indications for Use: "Microalbuminurea has been shown to predict the development of clinically significant nephropathy in diabetic patients. This Urinary Microalbumin Assay Kit is an in vitro immunoturbidimetric test for the quantitative determination of the native, immunoreactive albumin present in human urine."

Therefore, I cannot fulfill the request for information on acceptance criteria, study details, and data provenance based on the provided text.

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The IMMAGE Immunochemistry System Microalbumin (MA) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Urine Protein Calibrator, is intended for the quantitative determination of micro quantities of albumin in urine by rate nephelometry.

The IMMAGE Immunochemistry System MA Reagent in conjunction with Beckman Urine Protein Calibrator, is intended for use in the quantitative determination of micro quantities of micro albumin in in human urine samples on Beckman's IMMAGE™ Immunochemistry System.

Here's an analysis of the provided text regarding the Beckman IMMAGE™ Immunochemistry System Microalbumin (MA) Reagent, structured according to your request:

In this case, the "device" is the IMMAGE™ Immunochemistry System Microalbumin (MA) Reagent, an in-vitro diagnostic test. The acceptance criteria for such devices typically revolve around analytical performance metrics that demonstrate its ability to accurately and reliably measure the intended analyte compared to a predicate device.

Acceptance Criteria and Reported Device Performance for IMMAGE™ Immunochemistry System Microalbumin (MA) Reagent

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in the document. However, based on the studies performed, the implicit acceptance criteria are that the IMMAGE MA Reagent demonstrates:

• Substantial Equivalence: Performance comparable to the predicate device (Beckman MA Microalbumin Reagent Kit).
• Analytical Performance: Acceptable linearity (demonstrated by method comparison), precision (imprecision study), and stability (shelf-life and open container stability).

2. Sample Size Used for the Test Set and Data Provenance

• Method Comparison:
  • Sample Size: n = 109 urine samples.
  • Data Provenance: Not explicitly stated, but clinical samples are implied as "urine samples." The country of origin and whether they were retrospective or prospective is not specified in this summary.
• Imprecision Study:
  • Sample Size: n = 80 measurements for each of the three levels (total 240 measurements for each imprecision type). These are likely replicates of control or spiked samples, not individual patient samples.
  • Data Provenance: Not specified, but standard laboratory controls or prepared samples would be used.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable for this type of in-vitro diagnostic device. The "ground truth" for analytical performance studies is established by a reference method (the predicate device in this case) or by careful preparation of known concentration standards. Expert interpretation of results is not typically the primary ground truth for an analytical performance claim.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for subjective interpretations (e.g., imaging studies) where multiple human readers are involved. For quantitative analytical tests like this, the 'ground truth' is a numerical value from a reference method or known standard, not a consensus interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No, an MRMC comparative effectiveness study was not done. This device is an in-vitro diagnostic reagent, not an AI-powered image analysis tool or decision support system that would involve human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Yes, the studies presented (method comparison, stability, imprecision) demonstrate the standalone performance of the IMMAGE MA Reagent on the IMMAGE Immunochemistry System. This is an "algorithm only" type of test in the sense that the instrument's measurement algorithm processes the chemical reaction data to produce a quantitative result without direct human interpretation of the measurement itself (beyond operating the instrument and interpreting the final numerical value).

7. The Type of Ground Truth Used

• For Method Comparison: The ground truth was established by comparing the IMMAGE MA Reagent to the Beckman MA Reagent on the Array® 360 System (the predicate method). This is a reference method comparison.
• For Imprecision Studies: The ground truth for the mean values was established by known concentrations of control or spiked samples (Level 1, Level 2, Level 3).

8. The Sample Size for the Training Set

Not explicitly stated or applicable in the traditional sense of machine learning. This is an analytical chemistry reagent, not a machine learning algorithm that requires a "training set" of data to learn patterns. The "training" for such a system would involve validating its chemical components and instrument parameters during development, but this is not typically referred to as a "training set" in regulatory submissions for these types of devices. If any 'training' data was used, it would be for internal development and optimization of the reagent and instrument parameters, not disclosed as a specific "training set" in a 510(k) summary.

9. How the Ground Truth for the Training Set Was Established

As explained above, the concept of a "training set" with established ground truth in the context of machine learning does not directly apply here. For the development and optimization of the reagent and instrument, the ground truth would have been established through:

• Known concentrations: Prepared solutions of microalbumin at precise concentrations.
• Reference materials: Certified reference materials for albumin.
• Historical data: Performance relative to established analytical methods during development.

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