(56 days)
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.
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 insert. BAS provides the mobile phase for the elution of these 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.
Here's an analysis of the provided text regarding the BAS Plasma Catecholamine Kit, structured to answer your questions about acceptance criteria and the supporting study:
Acceptance Criteria and Device Performance Study
The primary study presented aims to demonstrate substantial equivalence of the BAS Plasma Cateamine Kit to a predicate device (Bio-Rad Plasma Catecholamine Kit by HPLC). While explicit "acceptance criteria" in the form of pre-defined thresholds for performance metrics are not clearly stated as such, the study's goal is to show a high correlation and consistency with the predicate device. The correlation coefficient (R value) appears to be a key metric used for this purpose.
1. Table of Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria (Implied) | Reported Device Performance (Epinephrine) | Reported Device Performance (Norepinephrine) |
|---|---|---|---|
| Correlation Coefficient (R value) | High correlation with predicate device (e.g., >0.95 or similar for substantial equivalence) | 0.994412 | 0.993926 |
| Slope | Close to 1 (indicating proportional agreement) | 1.075183 | 1.091721 |
| Y-intercept | Close to 0 (indicating minimal constant bias) | 13.35 | -9.17 |
| Range (ng/mL) | Comparable to predicate device | 15.8 - 2434 | 130 - 3488 |
| Mean (pg/mL) | Comparable to predicate device | BAS: 441, CAD: 393 | BAS: 827, CAD: 760 |
| Standard Deviation (pg/mL) | Comparable to predicate device | BAS: 558, CAD: 514 | BAS: 720, CAD: 653 |
Note: The "Acceptance Criteria (Implied)" are inferred from the context of substantial equivalence demonstrations, where high correlation and close agreement with a legally marketed device are typically required. The document does not explicitly state numerical thresholds as "acceptance criteria."
2. Sample Size and Data Provenance
- Sample Size for Test Set: 70 samples were used for both Epinephrine and Norepinephrine analysis.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It refers to human plasma samples, but no further details about their collection or demographic information are provided.
3. Number of Experts and their Qualifications for Ground Truth
- This study does not involve human expert interpretation to establish ground truth in the traditional sense of image analysis or diagnostic assessment. The "ground truth" here is effectively the measurement obtained by the predicate device (Bio-Rad Plasma Catecholamine Kit by HPLC).
- Therefore, information about the number or qualifications of experts for ground truth establishment is not applicable to this type of chemical assay comparison.
4. Adjudication Method for the Test Set
- As the "ground truth" is established by the predicate device's measurements, there is no adjudication method involved in the human expert sense. The comparison is directly between the new device's measurements and the predicate device's measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done. This study is a direct comparison of analytical performance between two in-vitro diagnostic devices, not an assessment of human reader performance or the impact of AI assistance.
6. Standalone Performance Study
- Yes, a standalone performance study was done in the sense that the BAS Plasma Catecholamine Kit's measurements were observed independently. However, its "performance" is implicitly defined by its correlation and agreement with the predicate device, rather than against an absolute, independent gold standard that is distinct from comparison reference. The table provided directly compares the BAS method against the predicate device (CAD) on the same samples.
7. Type of Ground Truth Used
- The "ground truth" in this study is the measurements obtained from the predicate device (Bio-Rad Plasma Catecholamine Kit by HPLC). This is a common approach for demonstrating substantial equivalence for in-vitro diagnostic devices, where an already approved method serves as the reference.
8. Sample Size for the Training Set
- The document does not explicitly mention a "training set" or "training data" in the context of device development. This is typical for a chemical assay kit comparison, where the device itself is a collection of reagents and a method, rather than a machine learning algorithm that requires training. The 70 samples appear to be for validation/comparison, not for training.
9. How Ground Truth for Training Set was Established
- As no training set is described, this question is not applicable.
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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 |
| Rangeng/mL | 243415.8 | 236912.2 | 3488130 | 3285163 |
| 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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l'age_1_ of 1
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)
§ 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.