(56 days)
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No
The device description details a laboratory test kit utilizing liquid chromatography and electrochemical detection, which are standard analytical chemistry techniques. There is no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is for in vitro diagnostic testing to determine the presence of compounds in plasma, which aids in diagnosis and treatment, but it is not directly used to treat or prevent disorders or sustain life.
Yes
The device is described as being used "in the diagnosis and treatment of adrenal medulla and hypertensive disorders, and for catecholamine secreting tumors." This indicates its role in identifying and characterizing medical conditions, which is the definition of a diagnostic device.
No
The device description explicitly states it is a "kit" that includes physical components like mobile phase, a liquid chromatography column, and critical reagents for sample preparation and analysis. It is an in vitro diagnostic (IVD) test system, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is "intended to determine whether a group of similar compounds epinephrine and norepinephrine are present in plasma." This is a diagnostic test performed on a biological sample (plasma) outside of the body.
- Indications for Use: The indications for use further solidify its diagnostic purpose by stating that the determinations are used "in the diagnosis and treatment of adrenal medulla and hypertensive disorders, and for catecholamine secreting tumors."
- Device Description: The description explicitly states that the kit is "designed for invitro applications only."
- Sample Type: The device analyzes "human plasma," which is a biological sample.
All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or congenital abnormality, or to monitor therapeutic measures.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
CHQ
Device 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.
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
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Intended User / Care Setting
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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)
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:
Mean Concentration for All Samples Assayed in pg/mL
Epinephrine: BAS Range ng/mL 2434 15.8, BAS Mean 441, BAS Std. Deviation 558; CAD Range ng/mL 2369 12.2, CAD Mean 393, CAD Std. Deviation 514. Cor. Coef. (R value) 0.994412, Y Intercept 13.35, Slope 1.075183.
Norepinephrine: BAS Range ng/mL 3488 130, BAS Mean 827, BAS Std. Deviation 720; CAD Range ng/mL 3285 163, CAD Mean 760, CAD Std. Deviation 653. Cor. Coef. (R value) 0.993926, Y Intercept -9.17, Slope 1.091721.
Number of Samples for Epinephrine (BAS and CAD) were 70.
Number of Samples for Norepinephrine (BAS and CAD) were 70.
Correlation Coefficient is based on the sample for sample regression of the assayed concentration.
BAS = BAS method; CAD = commercially available device method (Bio-Rad)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Cor. Coef. (R value) for Epinephrine: 0.994412
Cor. Coef. (R value) for Norepinephrine: 0.993926
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Bio-Rad Plasma Catecholamine by HPLC Kit
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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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AUG - 4 1997
11:00:00 Paul
0773171997
510 (k) Summary BAS Plasma Catecholamine Kit Summary of Bafety and Effectiveness : 上一篇: 100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
the state of the state of the same of the same of the list
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 | ||||
| ng/mL | 2434 | |||
| 15.8 | 2369 | |||
| 12.2 | 3488 | |||
| 130 | 3285 | |||
| 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: (765) 463-4527
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 (770) 488-7655.
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 (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" (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 (800) 638-2041 or (301) 443-6597 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,
(IPLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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)