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No
The description focuses on standard chromatographic data processing (integration, peak identification, calculations) and instrument control, with no mention of AI or ML terms or concepts.
No
The device is used for quantitative analyses of HPLC test kits, integrating chromatograms, identifying reference peaks, performing calculations, and controlling laboratory equipment, which are all analytical functions and not direct therapeutic interventions.
No
The device is described as a software package and instrument interface used for quantitative analyses of HPLC test kits. It accepts signals from a detector, integrates chromatograms, identifies reference peaks, performs calculations (like percent area), and can control pumps and samplers. While it performs analyses of lab test results, it does not directly diagnose a condition or disease in a patient. Instead, it provides data related to the chemical composition of samples, which a healthcare professional might then use as part of a diagnostic process. The performance studies also focus on analytical metrics (sensitivity, accuracy) for chemical assays, rather than diagnostic accuracy for a medical condition.
No
The device description explicitly states it includes a "separate communications interface" and "accepts signals from a detector," indicating hardware components beyond just software.
Based on the provided information, this device is likely an IVD (In Vitro Diagnostic). Here's why:
- Intended Use: The software and instrument interface are used for "quantitative analyses of high performance liquid chromatography (HPLC) test kits." HPLC is a common technique used in clinical laboratories to analyze biological samples (like urine and plasma, as mentioned in the performance studies) for the presence and quantity of specific substances. Analyzing test kits in this context strongly suggests an in vitro diagnostic purpose.
- Device Description: The device processes signals from a detector, integrates chromatograms, identifies peaks, and performs calculations. These are all standard functions for analyzing data generated from in vitro diagnostic tests using chromatography.
- Performance Studies: The performance studies explicitly mention analyzing biological samples ("HVA by HPLC, Urinary Metanephrines by HPLC, VMA by HPLC, Plasma Catecholamines by HPLC, Benzodiazepines & Tricyclic Antidepressants by HPLC"). These are all analytes commonly measured in clinical settings for diagnostic purposes. The comparison to another device (Shimadzu CR501) and the evaluation of analytical sensitivity and accuracy further support its use in a diagnostic context.
- Predicate Device: The predicate device (Hewlett-Packard 3392A Reporting Integrator) is also a reporting integrator, which is a type of device used in conjunction with analytical instruments like HPLC for processing and reporting results from diagnostic tests.
While the information doesn't explicitly state "for diagnostic purposes," the combination of analyzing HPLC test kits, processing data from biological samples, and the nature of the predicate device strongly indicates that this device is intended to be used in the performance of in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
A software package and instrument interface that is used for quantitative analyses of high performance liquid chromatography (HPLC) test kits.
Product codes
75 JQP
Device Description
The CDM makes use of a 486 IBM compatible computer and a separate communications interface. The system is described in detail in Appendix C. In brief, the CDM accepts signals from a detector, integrates the chromatograms, identifies reference peaks and performs calculations of percent area. In addition, the CDM can control pumps and an automated sampler and store quality control data.
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
An analytical comparison of the CDM and the Shimadzu CR501 was done for each of the following five tests: 1) HVA by HPLC 2) Urinary Metanephrines by HPLC, 3) VMA by HPLC, 4) Plasma Catecholamines by HPLC, 5) Benzodiazepines & Tricyclic Antidepressants by HPLC.
Summary of Performance Studies
Analytical comparison of CDM and Shimadzu CR501 for five HPLC tests.
- HVA by HPLC:
- CR501 SD 0.018, CV 3.6%; CDM SD 0.020 CV 4.0%.
- Correlation coefficient of 0.9999, y-intercept of 0.011, and slope of 0.994.
- Results comparable to CR501 integrator.
- Urinary Metanephrines by HPLC:
- Metanephrine CR501 SD 0.986, CV 6.8%; Metanephrine CDM SD 0.796, CV 5.5%.
- Normetanephrine CR501 SD 1.118, CV 6.0%; Normetanephrine CDM SD 1.345 CV 7.6%.
- 3-Methoxytyramine CR501 SD 0.750, CV 9.6%; 3-Methoxytyramine CDM SD 0.546 CV 7.8%.
- Metanephrine CDM: correlation coefficient of 0.9999, y-intercept of -1.074, and slope of 1.017.
- Normetanephrine CDM: correlation coefficient of 0.9999, y-intercept of -2.867, and slope of 1.023.
- 3-Methoxytyramine CDM: correlation coefficient of 0.999, y-intercept of -0.552, and slope of 0.999.
- Results comparable to CR501 integrator.
- VMA by HPLC:
- CR501 VMA SD 0.010, CV 1.9%; CDM VMA SD 0.010, CV 1.9%.
- CDM VMA: correlation coefficient of 0.9998, y-intercept of -0.002, and slope of 0.994.
- Results comparable to CR501 integrator.
- Plasma Catecholamines by HPLC:
- Epinephrine CR501 SD 2.72, CV 18%; Epinephrine CDM SD 1.32, CV 13%.
- Norepinephrine CR501 SD 5.04, CV 14%; Norepinephrine CDM SD 3.74, CV 12%.
- Epinephrine CDM: correlation coefficient 0.9998, y-intercept -2.90, and slope 0.979.
- Norepinephrine CDM: correlation coefficient 0.9999, y-intercept -4.43, and slope 1.003.
- Results comparable to CR501 integrator.
- Benzodiazepines & Tricyclic Antidepressants by HPLC:
- Benzodiazepine by HPLC: mean CR501 SD 1.64; mean CR501 CV 6.44%; mean CDM SD 1.59; mean CDM CV 5.92%.
- Benzodiazepine accuracy: mean correlation coefficient of 0.9998, mean y-intercept -0.156, and mean slope 0.9982.
- Tricyclic antidepressants by HPLC: CR501 mean SD 1.37, mean CV 5.23%; CDM mean SD 1.24, mean CV 4.74%.
- Tricyclic antidepressants accuracy: mean correlation coefficient of 0.9997, mean y-intercept 4.25, and mean slope 0.955.
- Equivalence shown between CDM and CR501 integrator.
Key Metrics
Analytical sensitivity, correlation coefficient, y-intercept, slope, CV.
Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.2260 High pressure liquid chromatography system for clinical use.
(a)
Identification. A high pressure liquid chromatography system for clinical use is a device intended to separate one or more drugs or compounds from a solution by processing the mixture of compounds (solutes) through a column packed with materials of uniform size (stationary phase) under the influence of a high pressure liquid (mobile phase). Separation of the solutes occurs either by absorption, sieving, partition, or selective affinity.(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 the logo for BIO-RAD. The logo is white text on a black background. The text is in a bold, sans-serif font. The logo is enclosed in a rounded rectangle.
Bio-Rad Laboratories
Diagnostics Group 4000 Alfred Nobel Drive Hercules, California 94547 1elephone: 510 724-7000 fax: 510 741-5824
SUMMARY OF SAFETY AND EFFECTIVENESS
Submitter: Bio-Rad Laboratories, Inc. Clinical Systems Division 4000 Alfred Nobel Hercules. California 94547 Phone 1 510 741-6015 Fax 1 510 741-5824
K9603922
JUL - 8 1988
Contact Person: Kenneth J. Kisco Specialist, Regulatory Affairs
Date prepared: January 25, 1996
Product Trade Name: CDM™
Common Name: Clinical Data Management System
Classification Name: Calculator/Data Processing Module, for Clinical use, 75 JQP
To establish substantial equivalence to an existing predicate device, the CDM has been compared to the Hewlett-Packard 3392A Reporting Integrator (K833113). A review of the intended use of each system shows them to be essentially the same. The intended use of the CDM is stated as: A software package and instrument interface that is used for quantitative analyses of high performance liquid chromatography (HPLC) test kits. The intended use of the 3392A Reporting Integrator is stated as: The 3392A is a multipurpose instrument that may be used for qualitative or quantitative analyses in many applications (see Appendix I).
A comparison of the technical features of the CDM and 3392A show the devices to be very similar. The CDM makes use of a 486 IBM compatible computer and a separate communications interface. The system is described in detail in Appendix C. In brief, the CDM accepts signals from a detector, integrates the chromatograms, identifies reference peaks and performs calculations of percent area. In addition, the CDM can control pumps and an automated sampler and store quality control data.
The predicate device, the H-P 3392A, is a CPU device with communication capability. Again. the 3392A accepts signals from a detector, integrates the chromatograms, identifies reference peaks and performs calculations of percent area. In addition, the 3392A can control an automated sampler. A complete comparison of the CDM and the predicate 3392A is summarized in Appendix D.
An analytical comparison of the CDM and the Shimadzu CR501 was done for each of the following five tests: 1) HVA by HPLC 2) Urinary Metanephrines by HPLC, 3) VMA by HPLC, 4) Plasma Catecholamines by HPLC, 5) Benzodiazepines & Tricyclic Antidepressants by HPLC.
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First, using the HVA by HPLC test, analytical sensitivity was: CR501 SD 0.018, CV 3.6%; CDM SD 0.020 CV 4.0%. Accuracy using HVA by HPLC test yielded a correlation coefficient of 0.9999, a y-intercept of 0.011, and a slope of 0.994. The HVA by HPLC test results for analytical sensitivity and method comparison given by the Clinical Data Management (CDM) System are comparable to those obtained using the CR501 integrator.
Second. using the urinary metanephrines by HPLC test for analytical sensitivity yielded the following: Metanephrine CR501 SD 0.986, CV 6.8%; Metanephrine CDM SD 0.796, CV 5.5%; Normetanephrine CR501 SD 1.118. CV 6.0%: Normetanephrine CDM SD 1.345 CV 7.6%; 3-Methoxytyramine CR501 SD 0.750, CV 9.6%; 3-Methoxytyramine CDM SD 0.546 CV 7.8%. CDM accuracy using the urinary metanephrines by HPLC was: Metanephrine CDM yielded a correlation coefficient of 0.9999, a v-intercept of -1.074, and a slope of 1.017; Normetanephrine CDM yeilded a correlation coefficient of 0.9999, a y-intercept of -2.867, and a slope of 1.023; 3-Methoxytyramine CDM yielded a correlation coefficient of 0.999, a y-intercept of -0.552, and a slope of 0.999. The urinary metanephrines by HPLC test results for sensitivity and method comparison given by the Clinical Data Management (CDM) System are comparable to those using the CR501 integrator
Third, using the VMA by HPLC test, analytical sensitivity was: CR501 VMA SD 0.010, CV 1.9%; CDM VMA SD 0.010, CV 1.9%. CDM VMA yielded a correlation coefficient of 0.9998, a yintercept of -0.002, and a slope of 0.994 The VMA by HPLC results for analytical sensitivity and method comparison given by the Clinical Data Management (CDM) System are comparable to those using the CR501 integrator.
Fourth, using the Plasma Catecholamines by HPLC test, analytical sensitivity was: Epinephrine CR501 SD 2.72, CV 18%; Epinephrine CDM SD 1.32, CV 13%; Norepinephrine CR501 SD 5.04.CV 14%: Norepinephrine CDM SD 3.74. CV 12%. Epinephrine CDM veilded a correlation coefficient 0.9998, a v-intercept -2.90, and a slope 0.979 and Norepinephrine CDM veilded a correlation coefficient 0.9999, a y-intercept -4.43, and a slope 1.003. The Plasma Catcholamines by HPLC test results for sensitivity and response comparison given by the Clinical Data Management (CDM) System are comparable to those using the CR501 integrator.
The fifth test used the bezodiazepines & tricyclic antidepressants by HPLC. Each of these tests measure mulitple analytes. The following data represent the means of the sensitivity and accuracy results. Using the Benzodiazepine by HPLC test method analytical sensitivity was: a mean CR501 SD 1.64; a mean CR501 CV 6.44%; a mean CDM SD 1.59; a mean CDM CV 5.92%. Accuracy for the Benzodiazepine by HPLC test method was: a mean correlation coefficient of 0.9998, a mean y-intercept -0.156, and a mean slope 0.9982.
Using the tricyclic antidepressants by HPLC test method, analytical sensitivity was: CR501 a mean SD 1.37 a mean CV 5.23%; CDM a mean SD 1.24 and a mean CV 4.74%. Accuracy for the tricyclic antidepressants by HPLC test method was: a mean correlation coefficient of 0.9997, a mean y-intercept 4.25 and a mean slope 0.955.
Equivalence was shown between the Clinical Data Management (CDM) system and the CR501 integrator in testing the following: 1) HVA by HPLC 2) Urinary Metanephrines by HPLC, 3) VMA by HPLC, 4) Plasma Catecholamines by HPLC, 5) Benzodiazepines & Tricyclic Antidepressants by HPLC.