The ESA Plasma Free Metanephrine Analysis Kit is intended for use in clinical laboratories that hold a CLIA certificate to perform tests of high complexity to measure endogenous free levels of the metanephrines (normetanephrine and metanephrine) in plasma using high performance liquid chromatography with electrochemical detection. The analysis of these analytes is used in the differential diagnosis of adult male and female patients with pheochromocytoma. For In Vitro Diagnostic Use Only.

Device Description

The ESA Free Plasma Motanephrine Analysis Kit consists of reagents for the extraction of metanephrines (normetanephrine and metanephrine) sufficient for 100 plasma samples. Sample clean-up is achieved with ion exchange solid phase extraction. The final extracts are ovaporated to dryness, reconstituted and analyzed via reversed phase ion-pair high performance liquid chromatography and electrochemical detection using the ESA CoulArray® detector. The multichannel electrode system oxidizes the metanepluines and the internal standard, 4-Hydroxy-3-mothoxybenzlamine (HMBA), followed by reduction at a downstream electrode. Total chromatographic run time is approximately 28 minutes per sample. Quantitative data analysis and report generation is performed using ESA CoulArray for Windows Data Station.

AI/ML Overview

The provided document is a 510(k) summary for the ESA Plasma Free Metanephrine Analysis Kit. It describes the device, its intended use, and states that its performance and reliability have been verified. However, it does not contain specific acceptance criteria, detailed study results, or information about sample sizes (for test or training sets), expert qualifications, ground truth establishment methods, or comparative effectiveness studies.

Therefore, I cannot populate most of the requested fields. The document confirms a "standalone" performance assessment was done, as it verifies the assay's performance.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not specified in document	- Adequate sensitivity was demonstrated.
Not specified in document	- Adequate precision was demonstrated.
Not specified in document	- Adequate linearity was demonstrated.
Not specified in document	- Adequate recovery was demonstrated.
Not specified in document	- Adequate detection limits were demonstrated.
Not specified in document	- Immunity from interferences was demonstrated.

2. Sample size used for the test set and the data provenance:

Sample Size (Test Set): Not specified in the document. The document mentions "plasma samples, augmented plasma samples, standards and controls" were used.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not specified. This is a diagnostic kit; the "ground truth" for its performance would typically be based on established analytical methods and clinical correlations, not necessarily expert image interpretation.

4. Adjudication method for the test set:

Not applicable/Not specified. This refers to consensus among human readers, which is not relevant for an in vitro diagnostic (IVD) assay performance study described here.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically for evaluating the impact of AI on human reader performance for tasks like image interpretation, which is not applicable to this IVD kit.

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

Yes, a standalone performance assessment was done. The document explicitly states: "Through the use of plasma samples, augmented plasma samples, standards and controls the performance and reliability of this assay has been verified." This refers to the independent analytical performance of the kit itself.

7. The type of ground truth used:

The implicit "ground truth" for assessing the kit's performance would be the known concentrations/presence of metanephrines in the standards, controls, and augmented plasma samples, as determined by reference analytical methods or known spiking concentrations. For clinical correlation, it would relate to the differential diagnosis of pheochromocytoma, but the verification described is about the analytical performance of the assay.

8. The sample size for the training set:

Not applicable/Not specified. This is an IVD kit, not a machine learning algorithm that requires a "training set" in the conventional sense. The "training" for such a kit involves its development and calibration using various samples, but these are not referred to as a "training set" in the context of AI/ML.

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

Not applicable/Not specified for the reasons stated above.

Summary

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Image /page/0/Picture/0 description: The image shows a logo with a stylized bird on the left and the word "esa" on the right. The bird is drawn with simple lines, suggesting a seagull in flight. The word "esa" is in a bold, sans-serif font, positioned next to the bird. The logo is in black and white.

JAN : 0 2004

510(k) SUMMARY

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 assigned 510(k) number is:K032199.

Submitter:	ESA Inc.22 Alpha RoadChelmsford, MA 01824 USAPhone: 978-250-7000Fax: 978-250-7090
Contact Person:	Harold AspQuality Assurance Manager
Date of SummaryPreparation:	January 29, 2004
Device Name:	ESA Plasma Free Metanephrine Analysis Kit
Classification Name:	Catecholamine (total) Test System862.1165
Predicate Device:	Model 5500 CEAS/Urinary Metanephrine andNorepinephrine
Statement ofIntended Use:	The ESA Plasma Free Metanephrine Analysis Kit isintended for use in clinical laboratories that hold aCLIA certificate to perform tests of high complexityto measure endogenous free levels of themetanephrines (normetanephrine and metanephrine)in plasma using high performance liquidchromatography with electrochemical detection.The analysis of these analytes is used in thedifferential diagnosis of adult male and femalepatients with pheochromocytoma.

For In Vitro Diagnostic Use Only

ESA, INC. ESA INTERNATIONAL, INC.

22 Alpho Road Chalmsford, MA 01824-4171 United States 1978) 250-7000 Fax (978) 2507090 www.ssalnc.com

ESA LABORATORIES, INC.

22 Alpha Rood Cholmsford, MA 01824-4171 United States (978) 250-7150 Fax (978) 250-7171

ESA ANALYTICAL, LTD.

Brook Form, Dorton Aylesbury, BuckInghamshire HP18 9NH England (01844) 239381 Fax (01544) 239382

ELECTROCHEMISTRY SEPARATIONS ANALYSIS

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Description of Device:

Similarities
Item	Device	Predicate
Intended Use	Quantitative Measurementof Plasma FreeMetanephrines	QuantitativeMeasurement of UrinaryMetanephrines
Indications forUse	Differential Diagnosis ofPheochromocytoma	Same
Methodology	High Performance LiquidChromatography	Same
Differences
Item	Device	Predicate
Matrix	Plasma	Urine

Technical Charactoristics Compared to Predicate:

Conclusions:

Through the use of plasma samples, augmented plasma samples, standards and controls the performance and reliability of this assay has been verified. In so doing adequate sensitivity, precision, linearity, recovery, detection limits and immunity from interferences has been demonstrated.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN S 0 2004

Mr. Harold Asp Ouality Assurance Manager ESA, Inc. 22 Alpha Road Chelmsford, MA 01824

K032199 Re:

Trade/Device Name: ESA Plasma Free Metanephrine Analysis Kit Regulation Number: 21 CFR 862.1165 Regulation Name: Catecholamines (total) test system Regulatory Class: Class I Product Code: CHO Dated: November 3, 2003 Received: November 4, 2003

Dear Mr. Asp:

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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Page 2

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.

Jean M. Cooper, MS, DVM.

Yean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K032199

Device Name: ESA Plasma Free Metanephrine Analysis Kit

Indications For Use:

For In Vitro Diagnostic Use Only

The ESA Plasma Free Metanephrine Analysis Kit is intended for use in clinical The EUT I laboratories that hold a CLIA certificate to perform tests of high complexity to measure endogenous free levels of the metanephrines (normetanephrine and metanephrine) in onasma using high performance liquid chromatography with electrochemical detection. The analysis of these analytes is used in the differential diagnosis of adult male and female patients with pheochromocytoma.

Prescription Use	✓
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol C. Benam for Jean Cooper, DVM
Division Sign-Off

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k 032199

Page 1 of

Regulation Number and Section

§ 862.1165 Catecholamines (total) test system.

(a)
Identification. A catecholamines (total) test system is a device intended to determine whether a group of similar compounds (epinephrine, norepinephrine, and dopamine) are present in urine and plasma. Catecholamine determinations are used in the diagnosis and treatment of adrenal medulla and hypertensive disorders, and for catecholamine-secreting tumors (pheochromo-cytoma, neuroblastoma, ganglioneuroma, and retinoblastoma).(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.