ATAC PAK BUN REAGENT by ELAN DIAGNOSTICS

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).

Summary

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JUL 12 2002

élan diagnostics

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021385

SUMMARY OF 510(K) SAFETY AND EFFECTIVENESS INFORMATION

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The ATAC PAK BUN Reagent Kit is substantially equivalent to the HiChem BUN Reagent Kit, product no. 88806, which is marketed by Elan Diagnostics Inc. of Brea California.

The effectiveness of ATAC PAK BUN Reagent Kit on the ATAC 8000 Random Access Chemistry System is shown by the following studies.

The recovery of urea nitrogen using the ATAC PAK BUN Reagent is linear from 2 to 100 mg/dL, as shown by the recovery of linearity standards that span the usable range. Regression statistics, which compare standard values, are shown below.

(ATAC Recoveries) = 0.6 mg/dL + 0.9775 x (Standard Value), sy.x = 1.2 mg/dL, n = 50

Precision is demonstrated by the replicate assay of commercially available control serum. Precision statistics, calculated analogous to the method described in NCCLS Guideline EP3-T, are shown below.

Precision of BUN Recoveries in mg/dL
	Within Run		Total
Sample	n	mean	1SD	%CV	1SD	%CV
Serum 1	60	7	0.3	4.4%	0.4	5.6%
Serum 2	60	34	0.5	1.5%	0.8	2.3%
Serum 3	60	61	0.9	1.4%	1.1	1.9%
Urine 1	60	21	0.4	2.1%	0.5	2.5%
Urine 2	60	80	1.0	1.3%	1.4	1.7%

Mixed serum, plasma and diluted urine specimens, collected from adult patients, were assaved for urea nitrogen using the ATAC 8000 Random Access Chemistry System and another commercially available method. Results were compared by least squares linear regression and the following statistics were obtained.

Serum/Plasma Comparison ATAC 8000 = 1.2 mg/dL + 0.977 x Competitive Reagent r = 0.996 n = 217 range = 5 - 100 mg/dL

Urine Comparison

ATAC 8000 = 1.9 mg/dL + 0.9525 x Competitive Reagent n = 92 range = 19 - 100 mg/dL r = 0.991

510(k) Notification, ATAC PAK BUN Reagent Kit, 29 April, 2002, p 45

Elan Diagnostics 1075 W. Lambert Road, Bldg. D · Brea California 92821 Phone: 714.672.3553 · Fax: 714.672.3554

Elan Diagnostics Is a division of Elan Pharmaceuticals

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The detection limit claim of 2 mg/dL is documented through the repetitive assay of a diluted serum control. The observed standard deviation of a 30 replicate within run precision study was 0 mg/dL. Consequently, the detection limit is reported as twice the round-off error of the assay.

The 14 day on board reagent stability and 14 day calibration stability claims are documented through the assay of serum controls and urine pools over the claimed periods. In all cases, the total imprecision of urea nitrogen recoveries over the test periods are less than 3 mg/dL or 3%.

Wigwam Stores

Wyma Stocking Manager of Regulatory Affairs Elan Diagnostics

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 1 2 2002

Mr. Wynn Stocking Regulatory Affairs Manager Elan Diagnostics 1075 W. Lambert Road Brea, CA 92821

Re: K021385

Trade/Device Name: ATAC PAK BUN Reagent Regulation Number: 21 CFR 862.1770 Regulation Name: Urea nitrogen test system Regulatory Class: Class II Product Code: CDQ Dated: April 29, 2002 Received: May 2, 2002

Dear Mr. Stocking:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050,

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and ' additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device. please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): . . K021385 ATAC PAK BUN Reagent Device Name: Indications for Use:

The ATAC PAK BUN Reagent Kit is intended for use with the ATAC 8000 Random Access Chemistry System for the quandtative determination of urea nitrogen in serum, plasma and urine. Utea nitrogen results are used in the diagnosis and treatment of certain renal and metabolic diseases.

This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.

Elan Diagnostics July 9, 2002

Dan Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K021385

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use __

(Optional Format 1-2-96)

Regulation Number and Section

§ 862.1770 Urea nitrogen test system.

(a)
Identification. A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.(b)
Classification. Class II.