PLASMA CATECHOLAMINE KIT

K972167 · Bioanalytical Systems, Inc. · CHQ · Aug 4, 1997 · Clinical Chemistry

Device Facts

• Record ID: K972167
• Device Name: PLASMA CATECHOLAMINE KIT
• Applicant: Bioanalytical Systems, Inc.
• Product Code: CHQ · Clinical Chemistry
• Decision Date: Aug 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1165
• Device Class: Class 1

Indications for Use

Catecholamine test system is a device intended to determine whether a group of similar compounds epinephrine and norepinephrine are present in 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.

Device Story

The BAS Plasma Catecholamine Kit is an in vitro diagnostic system used to measure epinephrine and norepinephrine levels in human plasma. The device utilizes liquid chromatography with electrochemical detection (LC-EC) under isocratic conditions to separate and quantitate these analytes. The kit includes a liquid chromatography column, mobile phase, and reagents for sample preparation. It is intended for use by laboratory professionals to assist in the diagnosis and treatment of adrenal medulla and hypertensive disorders, as well as catecholamine-secreting tumors. By providing quantitative data on catecholamine concentrations, the device aids clinicians in identifying pathological states associated with abnormal hormone secretion, thereby informing clinical management and treatment decisions.

Clinical Evidence

Bench testing only. Comparative study of 70 human plasma samples analyzed using both the BAS method and the predicate Bio-Rad HPLC kit. Results showed high correlation for epinephrine (R=0.994, mean 441 vs 393 pg/mL) and norepinephrine (R=0.993, mean 827 vs 760 pg/mL).

Technological Characteristics

In vitro diagnostic kit utilizing liquid chromatography with electrochemical detection (LC-EC). Employs isocratic elution. Includes proprietary mobile phase and sample preparation reagents. Standalone laboratory system.

Indications for Use

Indicated for patients requiring diagnostic assessment of adrenal medulla and hypertensive disorders, or screening for catecholamine-secreting tumors including pheochromocytoma, neuroblastoma, ganglioneuroma, and retinoblastoma.

Regulatory Classification

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).

Predicate Devices

• Bio-Rad Plasma Catecholamine by HPLC Kit

Submission Summary (Full Text)

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AUG - 4 1997

11:00:00 Paul

0773171997

## 510 (k) Summary BAS Plasma Catecholamine Kit Summary of Bafety and Effectiveness : 上一篇: 100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

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## Intended Use:

|【国際北海道】【

Catecholamine test system is a device intended to determine whether a group of similar compounds epinephrine and norepinephrine are present in 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.

Description: The BAS Plasma Catecholamine Kit employs liquid chromatography with electrochemical detection to separate and quantitate epinephrine (E) and norepinephrine (NE) in human plasma under isocratic conditions as defined in the package BAS provides the mobile phase for the elution of these insert. analytes from the liquid chromatography column, which is also provided, as well as critical reagents for sample preparation. There is one complete start-up kit as well as one accessory replacement kit which will be offered for sale. The accessory replacement kit contains replacement reagents and mobile phase for sample preparation and analysis. The kit is designed for invitro applications only. All reagents and kit supplies contain the appropriate warnings as to irritants, corrosiveness or toxicity, etc. The Plasma Catecholamine Kit is not used in any way to sustain human life or to prevent impairment of human health. Therefore, the kit poses no safety hazard to the patients. The Bioanalytical Systems Plasma Catecholamine Kit has been demonstrated to be substantially equivalent to the Bio-Rad Plasma Catecholamine by HPLC Kit.

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When the Bioanalytical Systems procedure was compared to the predicate device (the Bio-Rad Plasma Catecholamine Kit by HPLC) the following correlation data were obtained:

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| Mean Concentration for All Samples Assayed in pg/mL | | | | |
|-----------------------------------------------------|--------------|--------------|----------------|-------------|
| | Epinephrine | | Norepinephrine | |
| | BAS | CAD | BAS | CAD |
| # of Samples | 70 | 70 | 70 | 70 |
| Range<br>ng/mL | 2434<br>15.8 | 2369<br>12.2 | 3488<br>130 | 3285<br>163 |
| Mean | 441 | 393 | 827 | 760 |
| Std. Deviation | 558 | 514 | 720 | 653 |
| Cor. Coef.(R value) | 0.994412 | | 0.993926 | |
| Y Intercept | 13.35 | | -9.17 | |
| Slope | 1.075183 | | 1.091721 | |

*Correlation Coefficient is based on the sample for sample regression of the assayed concentration

BAS = BAS method; CAD = commercially available device method (Bio-Rad)

Submitter: Stephen Geary

Company: Bioanalytical Systems, Inc.

Address: 2701 Kent Avenue West Lafayette, IN 47906

Contact Person: Stephen Geary

Telphone: [phone]

Date Submitted: July 30, 1997

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with a serpent entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Stephen Geary Project Manager Clinical Chemistry Kits ... . Bioanalytical Systems, Inc. 2701 Kent Avenue West Lafayette, IN 47906

AUG - 4 1997

Re: K972167 Plasma Catecholamine Kit Requlatory Class: I Product Code: CHQ Dated: June 6, 1997 Received: June 9, 1997

Dear Mr. Geary:

: : | 【刘易寻找到保守】

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Litman

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

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Enclosure

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510(k) Number (if known):

Device Name:_Plasma Catecholamine Kit

Indications For Use:

11/11/2017

Catecholamine test system is a device intended to determine whether a group of similar compounds epinephrine and norepinephrine are present in plasma. Catecholamine noreminations are used in the diagnosis and treatment of adrenal medulla and hypertensive disorders, and for catecholamine secreting tumors (pheochromo-cytoma, neuroblastoma, ganglioneuroma, and retinoblastoma,

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory evices
510(k) Number. K972667

Prescription Use
OR
Over-The-Counter Use__
(Per 21 CFR 801.109)

(Optional Format 1-2-96)