ATAC PAK ALBUMIN REAGENT by ELAN DIAGNOSTICS

The ATAC PAK Albumin 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 albumin in serum and plasma. Albumin results are used for the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Device Description

The ATAC PAK Albumin Reagent Kit is intended for the quantitative determination of albumin in serum and plasma. Albumin results are used for the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys. The ATAC PAK Albumin Reagent determines albumin by the selective binding of bromcresol green. The resulting increase in absorbance at 630 nm is proportional to the albumin concentration in the sample.

AI/ML Overview

The ATAC PAK Albumin Reagent Kit is intended for the quantitative determination of albumin in serum and plasma. The study presented demonstrates its substantial equivalence to the Roche Albumin Reagent Kit (product no. 1970569).

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (Implied by equivalence to predicate)	Reported Device Performance	Study Type
Linearity Range	Equivalent to predicate (e.g., span useable range)	0.1 to 8 g/dL	Linearity/Recovery
Recovery Regression	High correlation (e.g., r > 0.99) and low Sy.x	ATAC = 0.04 + 0.902x (Ref), r = 0.999, Sy.x = 0.11 g/dL	Linearity/Recovery
Within-Run Precision	%CV typically < 5% for clinical assays	Serum 1: 2.5% CV (at 2.5 g/dL) Serum 2: 2.3% CV (at 3.9 g/dL) Serum 3: 1.6% CV (at 5.3 g/dL)	Precision
Total Precision	%CV typically < 5% or 10% for clinical assays	Serum 1: 3.3% CV (at 2.5 g/dL) Serum 2: 2.8% CV (at 3.9 g/dL) Serum 3: 2.3% CV (at 5.3 g/dL)	Precision
Method Comparison (Correlation)	High correlation and low bias when compared to predicate	ATAC 8000 = 0.5 + 0.867 x Competitive Reagent, Sy.x = 0.11 g/dL	Method Comparison
Method Comparison (Range)	Cover clinically relevant range	1.9 - 5.4 g/dL	Method Comparison
Detection Limit	Below the lowest clinically relevant value	0.1 g/dL	Detection Limit
Reagent Stability (Onboard)	Maintain performance over claim	Total imprecision < 0.15 g/dL or 3% over 14 days	Stability
Calibration Stability	Maintain performance over claim	Total imprecision < 0.15 g/dL or 3% over 7 days	Stability

2. Sample Size and Data Provenance

Linearity/Recovery: n = 33 (implied by the regression statistics, corresponding to pairs of ATAC recoveries vs. Reference Values). The data provenance is not explicitly stated but implies laboratory-prepared linearity standards.
Precision:
- Serum 1: n = 60 replicates
- Serum 2: n = 60 replicates
- Serum 3: n = 60 replicates
- The samples used are "commercially available control serum." The country of origin is not specified, and the study is prospective in nature for determining precision.
Method Comparison: n = 119 for mixed serum and plasma specimens. These were "collected from adult patients," suggesting a prospective collection of clinical samples. The country of origin is not specified.
Detection Limit: n = 30 replicates of a diluted serum pool. This is a prospective study.
Stability Studies: "serum controls" were assayed. Specific sample sizes for controls are not given, but the study is prospective.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This device is a diagnostic reagent kit, and the "ground truth" for its performance is established through analytical validation studies using reference methods, standards, and control materials, rather than expert consensus on diagnostic images or clinical outcomes.

4. Adjudication Method

Not applicable. As described above, the studies involve analytical measurements against established reference values or comparative measurements with a predicate device, not subjective interpretation requiring expert adjudication.

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

No, a multi-reader multi-case comparative effectiveness study was not done. This type of study is typically performed for medical imaging devices where human interpretation is a critical component of the diagnostic process. This submission pertains to an in-vitro diagnostic reagent kit for quantitative biochemical measurement.

6. Standalone Performance Study

Yes, a standalone (algorithm only) performance study was done for the ATAC PAK Albumin Reagent Kit. The studies presented (linearity, precision, method comparison, detection limit, stability) directly assess the performance of the reagent kit when run on the ATAC 8000 Random Access Chemistry System, without human interpretive input affecting the core measurement.

7. Type of Ground Truth Used

The ground truth for the performance studies was established through:

Reference Values: For linearity, values are compared against "Reference Value" standards.
Commercial Control Serum: For precision, commercially available control sera with assigned values (mean, 1SD, %CV) serve as the reference.
Predicate Device/Commercially Available Method: For method comparison, the results from the ATAC PAK Albumin Reagent Kit are compared against results from an "another commercially available method" (the predicate device).
Established Analytical Principles: For detection limit, it's based on the statistical calculation from repetitive assays of a diluted serum pool.

8. Sample Size for the Training Set

Not applicable. This device is an in-vitro diagnostic reagent kit, not an AI or machine learning algorithm that requires a "training set" in the conventional sense. Its performance is based on chemical reactions and photometric measurements. The manufacturing process and quality control would be validated, but there isn't a "training set" for the reagent itself.

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

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

Summary

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1075 W. Lambert Road Building D Brea, California 92821 T (714) 672 3553 F (714) 672 3554

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 Albumin Reagent Kit is substantially equivalent to the Roche Albumin Reagent Kit, product no. 1970569, which is marketed by Roche Diagnostics of Indianapolis, IN. The effectiveness of ATAC PAK Albumin Reagent Kit on the ATAC 8000 Random Access Chemistry System is shown by the following studies.

The recovery of albumin using the ATAC PAK Albumin Reagent is linear from 0.1 to 8 g/dL, as shown by the recovery of linearity standards that span the usable range. Regression statistics compare standard values. These statistics are shown below.

(ATAC Recoveries) = 0.04 g/dL + 0.902 x (Reference Value), r = 0.999, Sy.x = 0.11 g/dL, n = 33

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.

Sample	n	mean	Within Run		Total
			1SD	%CV	1SD	%CV
Serum 1	60	2.5	0.06	2.5%	0.08	3.3%
Serum 2	60	3.9	0.09	2.3%	0.11	2.8%
Serum 3	60	5.3	0.09	1.6%	0.12	2.3%

Mixed serum and plasma specimens, collected from adult patients, were assayed for albumin using the ATAC 8000 Random Access Chemistry System and another commercially available method. Results were compared by Deming regression and the following statistics were obtained.

ATAC 8000 = 0.5 g/dL + 0.867 x Competitive Reagent range = 1.9 - 5.4 g/dL Sy.x = 0.11 g/dL n = 119

The detection limit of 0.1 /dL is documented through the repetitive assay of a diluted serum pool. The observed standard deviation of a 30 replicate within run precision study was 0.018 g/dL. Consequently, the detection limit is reported as the round-off error of the assay.

The 14 day onboard reagent stability and 7 day calibration stability claims are documented through the assay of serum controls over the claimed periods. In all cases, the total imprecision of albumin recoveries over the test than 0.15 g/dL or 3%.

Wynne Stocking
Wynne Stocking

Wynn Stocking Manager of Regulatory Affairs Elan, Brea California

510(k) Notification, ATAC PAK Albumin Reagent Kit, 31 December, 2002, p 55

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 0 7 2003

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

Re: K030006 Trade/Device Name: ATAC PAK Albumin Reagent Regulation Number: 21 CFR 862.1035 Regulation Name: Albumin test system Regulatory Class: Class II Product Code: CIX Dated: December 31, 2002 Received: January 2, 2003

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, listing 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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device. or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

K030006

Device Name:

ATAC PAK Albumin Reagent

Indications for Use:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sean Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number ×630006

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 862.1035 Albumin test system.

(a)
Identification. An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.(b)
Classification. Class II.