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The ATAC PAK BUN Reagent Kit is intended for the quantitative determination of urea nitrogen in serum, plasma and urine. Urea nitrogen results are used in the diagnosis and treatment of certain renal and metabolic diseases.

Device Description

The ATAC PAK BUN Reagent determines urea nitrogen through the enzymatic action of urease and glutamate delydrogenase. The resulting decrease in absorbance at 340 nm is proportional to the urea nitrogen concentration of the sample.

AI/ML Overview

This document focuses on the ATAC PAK BUN Reagent Kit, an in-vitro diagnostic device designed for the quantitative determination of urea nitrogen. The provided text describes the device's performance characteristics and how they demonstrate substantial equivalence to a predicate device, as required for 510(k) clearance by the FDA.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (Implied/Direct)	Reported Device Performance
Linearity/Recovery	Linear from 2 to 100 mg/dL	(ATAC Recoveries) = 0.6 mg/dL + 0.9775 x (Standard Value), sy.x = 1.2 mg/dL. The recovery of urea nitrogen is linear from 2 to 100 mg/dL.
Precision (Within Run)	Not explicitly stated but implied to be low CV% to demonstrate reliability	Serum 1: n=60, mean=7 mg/dL, 1SD=0.3, %CV=4.4% Serum 2: n=60, mean=34 mg/dL, 1SD=0.5, %CV=1.5% Serum 3: n=60, mean=61 mg/dL, 1SD=0.9, %CV=1.4% Urine 1: n=60, mean=21 mg/dL, 1SD=0.4, %CV=2.1% Urine 2: n=60, mean=80 mg/dL, 1SD=1.0, %CV=1.3%
Precision (Total)	Not explicitly stated but implied to be low CV% to demonstrate reliability	Serum 1: 1SD=0.4, %CV=5.6% Serum 2: 1SD=0.8, %CV=2.3% Serum 3: 1SD=1.1, %CV=1.9% Urine 1: 1SD=0.5, %CV=2.5% Urine 2: 1SD=1.4, %CV=1.7%
Method Comparison (Serum/Plasma)	Strong correlation (high r-value) and close agreement with competitive method	ATAC 8000 = 1.2 mg/dL + 0.977 x Competitive Reagent, r = 0.996
Method Comparison (Urine)	Strong correlation (high r-value) and close agreement with competitive method	ATAC 8000 = 1.9 mg/dL + 0.9525 x Competitive Reagent, r = 0.991
Detection Limit	2 mg/dL	2 mg/dL (documented by repetitive assay of diluted serum control, 30 replicates, 0 mg/dL std dev)
On-board Reagent Stability	14 days; total imprecision < 3 mg/dL or 3% over period	Meets 14-day claim, with total imprecision < 3 mg/dL or 3%.
Calibration Stability	14 days; total imprecision < 3 mg/dL or 3% over period	Meets 14-day claim, with total imprecision < 3 mg/dL or 3%.

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

Linearity/Recovery: n = 50 (for regression statistics comparing standard values).
Precision:
- Serum 1: n = 60
- Serum 2: n = 60
- Serum 3: n = 60
- Urine 1: n = 60
- Urine 2: n = 60
  (Precision studies used commercially available control serum and urine pools.)
Method Comparison (Serum/Plasma): n = 217.
Method Comparison (Urine): n = 92.
Detection Limit: 30 replicates of a diluted serum control.

Data Provenance: The document states that mixed serum, plasma, and diluted urine specimens were "collected from adult patients." It also mentions "commercially available control serum." The country of origin is not specified, but the submission is to the U.S. FDA, suggesting the data would comply with U.S. regulatory standards. The studies appear to be prospective as they were conducted to demonstrate the performance of the ATAC PAK BUN Reagent Kit.

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

This type of in-vitro diagnostic (IVD) device study does not typically involve "experts" establishing a ground truth in the way medical imaging or clinical diagnosis studies do. For IVDs, the "ground truth" is established through:

Reference materials: For linearity, known standard values are used.
Established analytical methods: For method comparison, a "competitive commercially available method" is used as a reference.
Control materials: For precision, commercially available control serum and urine pools with known target ranges are used.

Therefore, the concept of "number of experts" and their "qualifications" for establishing ground truth is not applicable here.

4. Adjudication Method for the Test Set

Not applicable. As described above, the ground truth is based on reference standards, established methods, and control materials, not on human interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

No, an MRMC comparative effectiveness study was not done. This is an in-vitro diagnostic device, not an imaging or diagnostic device that relies on human interpretation of complex data. The study focuses on the analytical performance of the reagent kit itself.

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

Yes, the studies described are standalone performance evaluations of the ATAC PAK BUN Reagent Kit on the ATAC 8000 Random Access Chemistry System. These are analytical performance studies of the device itself, without human intervention in the result determination process beyond standard laboratory operating procedures.

7. The Type of Ground Truth Used

Linearity: Known standard values/concentrations.
Precision: Commercially available control serum and urine pools with established target ranges.
Method Comparison: Results from a "commercially available method" (i.e., another established and validated BUN assay). This serves as the comparative reference.
Detection Limit: Diluted serum control with a known low concentration.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI models, as this is an in-vitro diagnostic reagent kit, not an AI-powered device. The studies described are performance validation studies.

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

As there is no explicit "training set" in the AI/machine learning sense, this question is not directly applicable. The performance characteristics are demonstrated using the previously described methods (reference materials, control materials, comparative methods).

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K Number

K000958

Device Name

ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS

Manufacturer

ELAN HOLDINGS, INC.

Date Cleared

2000-05-24

(61 days)

Product Code