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ACE Albumin Reagent is intended for the quantitative determination of albumin concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

ACE Total Protein Reagent is intended for the quantitative determination of total protein concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Total protein measurements 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. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

ACE Calcium-Arsenazo Reagent is intended for the quantitative determination of calcium concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

ACE Inorganic Phosphorus U.V. Reagent is intended for the quantitative determination of inorganic phosphorus concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Measurements of inorganic phosphorus are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases and vitamin D imbalance. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

In the ACE Albumin Reagent assay, Bromcresol green binds specifically to albumin to form a green colored complex, which is measured bichromatically at 629 nm/692 nm. The intensity of color produced is directly proportional to the albumin concentration in the sample.

In the ACE Total Protein Reagent assay, cupric ions react with the peptide bonds of proteins under alkaline conditions to form a violet colored complex, which is measured bichromatically at 544 nm/692 nm. The intensity of color produced is directly proportional to the total protein concentration in the sample.

In the ACE Calcium-Arsenazo Reagent assay, calcium reacts with Arsenazo III in an acidic solution to form a blue-purple colored complex, which is measured bichromatically at 647 nm/692 nm. The intensity of color produced is directly proportional to the calcium concentration in the sample.

In the ACE Inorganic Phosphorus U.V. Reagent assay, under acidic conditions, inorganic phosphorus in serum reacts with ammonium molybdate to form an unreduced phosphomolybdate complex, which absorbs strongly at 340 nm. The increase in absorbance, measured bichromatically at 340 nm/378 nm, is directly proportional to the amount of phosphorus in the sample.

Here's an analysis of the acceptance criteria and study information for the ACE Albumin Reagent, ACE Total Protein Reagent, ACE Calcium-Arsenazo Reagent, and ACE Inorganic Phosphorus U.V. Reagent, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The provided documentation does not explicitly state formal "acceptance criteria" with specific thresholds for each performance metric. However, it presents detailed performance data, particularly precision (within-run and total %CV) and method comparison (regression analysis, correlation coefficient), comparing the new reagents on various ACE clinical chemistry systems (ACE, ACE Alera, ACE Axcel) against existing predicate devices and among themselves. The implied acceptance is that the new reagents perform comparably to, or as effectively as, the predicate devices and demonstrate acceptable precision and linearity for clinical use.

Below is a summary of the reported device performance based on the "In-House Precision" and "In-House Matrix Comparison" tables. Since explicit acceptance criteria are not given, the performance data itself is presented as the evidence of meeting implied clinical utility and equivalence to predicate devices.

ACE Albumin Reagent

ACE Total Protein Reagent

ACE Calcium-Arsenazo Reagent

ACE Inorganic Phosphorus U.V. Reagent

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

The studies mentioned are "In-House Precision," "In-House Matrix Comparison: Serum vs. Plasma," "POL - Precision," and "POL – Method Comparison."

• In-House Precision (Serum vs. Plasma):
  • Sample Size: Not explicitly stated for each "low, mid, high" concentration level, but implies multiple replicates for each level tested across the three systems (ACE, Alera, Axcel). For example, the ACE Alera precision table (pg. 16) shows 3 levels (low, mid, high) for serum, with reported mean, within-run SD, and total SD. Typically, precision studies involve running samples multiple times a day over several days.
  • Data Provenance: "In-House" suggests it was conducted by Alfa Wassermann Diagnostic Technologies, LLC, likely at their own facilities. It is a prospective study as they are performing experiments to generate data.
• In-House Matrix Comparison: Serum vs. Plasma:
  • Sample Size:
    • Albumin: ACE: 55 pairs, ACE Alera: 56 pairs, ACE Axcel: 56 pairs
    • Total Protein: ACE: 56 pairs, ACE Alera: 56 pairs, ACE Axcel: 81 pairs
    • Calcium-Arsenazo: ACE: 56 pairs, ACE Alera: 56 pairs, ACE Axcel: 81 pairs
    • Inorganic Phosphorus: ACE: 100 pairs, ACE Alera: 102 pairs, ACE Axcel: 56 pairs
  • Data Provenance: "In-House" suggests it was conducted by Alfa Wassermann Diagnostic Technologies, LLC, likely at their own facilities. The comparison between serum and plasma samples implies these were collected from human subjects. This is a prospective study.
• POL (Physician Office Laboratory) - Precision:
  • Sample Size: For each reagent and each system (ACE and ACE Alera), there are 3 "samples" (representing different concentration levels) tested at 3 different POL sites. Each sample/site combination has "Within-Run" and "Total" precision reported, implying multiple replicates for each measurement.
  • Data Provenance: Conducted at "POL 1," "POL 2," and "POL 3" sites, indicating external collection and testing beyond the manufacturer's immediate facilities. This is a prospective study.
• POL (Physician Office Laboratory) - Method Comparison:
  • Sample Size:
    • Albumin: 50 samples for each POL site (x3 POLs)
    • Total Protein: 51 samples for each POL site (x3 POLs)
    • Calcium-Arsenazo: 50 samples for each POL site (x3 POLs)
    • Inorganic Phosphorus: 50 samples for POL 1 & 3, 48 samples for POL 2
  • Data Provenance: Comparisons between "ACE In-House (x)" and "ACE POL (y)" or "ACE In-House (x)" and "ACE Alera POL (y)". This indicates the data for these studies was collected at both in-house facilities and external Physician Office Laboratories. This is a prospective study design, comparing results from different testing environments.
• Detection Limits & Linearity (ACE Alera):
  • Sample Size: Not specified for these specific studies, but typically involves a series of diluted and concentrated samples to define the measuring range.
  • Data Provenance: In-House, prospective.
• Interference (ACE Alera):
  • Sample Size: Not specified, but involves spiking samples with various interferents at different concentrations.
  • Data Provenance: In-House, prospective.

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

For these types of in vitro diagnostic (IVD) assays, the "ground truth" is typically established by reference methods or validated comparative methods, often using certified calibrators and controls. The documentation does not mention the use of human experts to establish ground truth for the test set in the traditional sense of medical image interpretation (e.g., radiologists interpreting images). Instead, the studies rely on quantitative measurements and statistical comparisons with established methods (the predicate devices or in-house reference measurements) to demonstrate performance. Therefore, no information is provided on the number or qualifications of experts for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. As described in point 3, the "ground truth" for these quantitative chemical assays is not established through expert consensus or adjudication in the way it would be for qualitative or interpretive diagnostic devices like medical imaging. Performance is evaluated by statistical comparison of numerical results.

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 device consists of chemical reagents for laboratory measurement, not an AI-assisted diagnostic tool interpreted by human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI is not relevant to this submission.

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

The performance presented for these reagents is inherently "standalone" in the sense that it reflects the direct analytical performance of the assays on the specified automated clinical chemistry systems. The results are quantitative measurements produced by the device without human interpretation of raw data beyond reading the numerical output. The "without human-in-the-loop" aspect applies here as the device itself performs the measurement and outputs a numerical value of concentration. The method comparison studies demonstrate the standalone performance of the candidate devices compared to predicate devices.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for these assays is established through reference methods and comparison to legally marketed predicate devices.

• For precision, the "ground truth" for each replicate is assumed to be the true concentration within the sample, and the study assesses the reproducibility of the device in measuring that concentration.
• For method comparison studies (e.g., In-House vs. POL, or ACE vs. ACE Alera), one method's results (often the predicate or an established in-house method) serve as the comparative 'truth' to evaluate the new method's agreement. The reference method would itself be calibrated against known standards.
• For linearity, samples of known, graded concentrations are used.
• For detection limits, the ground truth involves samples with very low, known concentrations.

These are established analytical chemistry principles rather than "expert consensus" or "pathology" in the diagnostic interpretation sense.

8. The Sample Size for the Training Set

The concept of a "training set" is primarily relevant for machine learning or AI algorithms which are iteratively developed and optimized using data. These reagents are chemical assays with a defined photometric measurement principle. While there is a development phase that involves optimizing reagent formulations and instrument parameters, there isn't a "training set" in the computational sense. The data presented here are from formal "verification and validation studies" to demonstrate performance characteristics (precision, linearity, accuracy/comparison, interference, detection limits).

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

As noted in point 8, the concept of a "training set" is not directly applicable to these chemical reagents. The "ground truth" for establishing and validating the performance of such assays is based on:

• Reference materials/calibrators: Solutions with precisely known concentrations of the analyte (albumin, total protein, calcium, phosphorus) traceable to international standards.
• Validated comparison methods: Measurements made by existing, legally marketed predicate devices or other well-established and accurate laboratory methods.
• Controlled spiking experiments: Adding known amounts of substance to samples to assess recovery, linearity, and interference.

These methods establish the quantitative "truth" against which the performance of the new reagents is measured.

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The ATAC PAK Phosphorus Reagent Kit is intended for use with the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System as a system for the quantitative determination of inorganic phosphorus in serum and plasma. Phosphorus results are used for the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.

The ATAC PAK Phosphorus Reagent determines phosphorus through its reaction with molybdate to form a phosphomolybdate complex. The resulting increase in absorbance at 340 nm is proportional to the phosphorus concentration in the sample.

Here's a breakdown of the acceptance criteria and the study details for the ATAC PAK Phosphorus Reagent Kit, based on the provided text:

1. A table of acceptance criteria and the reported device performance

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The Roche Diagnostics, Boehringer Mannheim Inorganic Phosphorus reagent is intended for use for the quantitative in vitro determination of phosphorus in human serum, plasma and urine with automated clinical chemistry analyzers.

According to the Code of Federal Regulations, Title 21 (Food and Drugs), Part 862.1580, a Phosphorus (inorganic) test system is a device intended to measure inorganic phosphorus in serum, plasma, and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.

Endpoint method with sample blanking.

Inorganic phosphate forms an ammonium phosphomolybdate complex with ammonium molybdate in the presence of sulfuric acid. The complex is determined photometrically in the ultraviolet region (340 nm).

The provided text describes the 510(k) summary for the Roche Diagnostics, Boehringer Mannheim Inorganic Phosphorus Reagent. This submission seeks substantial equivalence to an existing device, focusing on extended claims for specimen collection, reportable range (urine), imprecision, and method comparison (urine).

Here's an analysis of the provided information concerning acceptance criteria and the study:

1. A table of acceptance criteria and the reported device performance:

The document describes the changes and similarities to the predicate device but does not explicitly state specific acceptance criteria (e.g., performance targets, accuracy thresholds) or provide a table directly comparing acceptance criteria with reported device performance for the extended claims.

However, it implicitly refers to performance characteristics for the extended claims. The "Limitations - Interferences" section provides some performance details related to interference, which could be considered partial performance data, though not directly tied to explicit acceptance criteria:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

The provided text does not specify the sample size used for the test set for any of the performance characteristics or the data provenance (country of origin, retrospective/prospective nature). It only states that specific data on the performance of the system has been incorporated into the draft labeling in Section V and that data related to extended claims is described in Section VI. These sections are not included in the provided document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This information is not applicable to this type of in vitro diagnostic device (reagent for chemical analysis). Ground truth for chemical assays is typically established through reference methods and calibrated instruments, not expert human interpretation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not applicable to this type of in vitro diagnostic device. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective human interpretation (e.g., medical imaging, pathology).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable to this type of in vitro diagnostic device. MRMC studies and concepts of human reader improvement with AI assistance are relevant to AI-based diagnostic tools that assist human interpreters (e.g., radiologists, pathologists). This device is a chemical reagent.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not applicable in the context of an AI algorithm. For this chemical reagent, "standalone performance" refers to the performance of the reagent on an automated clinical chemistry analyzer without manual human intervention in the measurement process, which is inherent to its intended use with "automated clinical chemistry analyzers." However, the document does not explicitly detail the standalone performance study protocol or results beyond general statements about "performance characteristics."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For this type of chemical reagent, the ground truth for performance evaluation (e.g., accuracy, precision) would typically be established using:

• Reference materials/calibrators: Samples with known, validated concentrations of inorganic phosphorus.
• Reference methods: Established, highly accurate analytical methods considered the gold standard for measuring inorganic phosphorus.

The document does not explicitly state the type of ground truth used, but these are the standard practices for verifying the performance of such devices.

8. The sample size for the training set:

This information is not applicable because the device is a chemical reagent, not an AI or machine learning algorithm that requires a "training set."

9. How the ground truth for the training set was established:

This information is not applicable as there is no "training set" for this chemical reagent.

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HiChem Phosphorus Reagent is intended for the quantitative determination of inorganic phosphorus in serum, plasma and urine for the diagnosis and treatment of various disorders including parathyroid gland and kidney diseases, and vitamin D imbalance.

The HiChem Phosphorus Reagent determines phosphorus by its reaction with molybdate in an acidic solution to form a phosphomolybdate complex. The resulting increase in absorbance at 340 nm is proportional to the phosphorus concentration in the sample.

The HiChem Phosphorus Reagent is an adaptation of the method first described by Simonsen and is intended for use with manual spectrophotometers or clinical analyzers which can automate the required manipulations.

Here's a breakdown of the HiChem Phosphorus Reagent device's acceptance criteria and the study information as detailed in the provided document:

This document describes a diagnostic reagent, not an AI/ML powered device, therefore some of the requested information (like MRMC studies, number of experts for ground truth, adjudication methods) is not applicable. I will provide the information that is applicable based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

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