(196 days)
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No
The device description focuses on chemical analysis techniques (HPLC with electrochemical detection) and standard data analysis software. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
This device is an in vitro diagnostic (IVD) kit used to measure specific markers in plasma for diagnostic purposes, not to treat or alleviate a disease or condition.
Yes
The device is intended for the "differential diagnosis of adult male and female patients with pheochromocytoma," indicating its use in diagnosing a medical condition.
No
The device description explicitly states it is a "Kit" consisting of "reagents" for sample extraction and analysis using "high performance liquid chromatography with electrochemical detection" and an "ESA CoulArray® detector." While it mentions "Quantitative data analysis and report generation is performed using ESA CoulArray for Windows Data Station," this software component is part of a larger system that includes significant hardware and chemical components for in vitro diagnostic testing.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states: "For In Vitro Diagnostic Use Only."
- Device Description: The description details a kit used to measure analytes in plasma (a biological sample) using laboratory techniques (HPLC with electrochemical detection). This is characteristic of an in vitro diagnostic test.
- Purpose: The analysis of the metanephrines is used in the "differential diagnosis of adult male and female patients with pheochromocytoma," which is a diagnostic purpose.
- Care Setting: It is intended for use in "clinical laboratories," which are the typical setting for performing IVD tests.
N/A
Intended Use / Indications for Use
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
Product codes
CHO
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 evaporated 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Adult male and female patients
Intended User / Care Setting
Clinical laboratories that hold a CLIA certificate to perform tests of high complexity
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
adequate sensitivity, precision, linearity, recovery, detection limits and immunity from interferences
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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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 Road
Chelmsford, MA 01824 USA
Phone: 978-250-7000
Fax: 978-250-7090 |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Harold Asp
Quality Assurance Manager |
| Date of Summary
Preparation: | January 29, 2004 |
| Device Name: | ESA Plasma Free Metanephrine Analysis Kit |
| Classification Name: | Catecholamine (total) Test System
862.1165 |
| Predicate Device: | Model 5500 CEAS/Urinary Metanephrine and
Norepinephrine |
| Statement of
Intended Use: | 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
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
1
Description of Device:
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.
| Similarities | ||
|---|---|---|
| Item | Device | Predicate |
| Intended Use | Quantitative Measurement | |
| of Plasma Free | ||
| Metanephrines | Quantitative | |
| Measurement of Urinary | ||
| Metanephrines | ||
| Indications for | ||
| Use | Differential Diagnosis of | |
| Pheochromocytoma | Same | |
| Methodology | High Performance Liquid | |
| Chromatography | 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.
2
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).
3
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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.
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
4
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
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