(54 days)
The Glucose Flex® reagent cartridge for the Dimension® clinical chemistry system is an in vitro diagnostic device intended to quantitatively measure glucose in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
The Glucose Flex® reagent cartridge (GLUC) for the Dimension® clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of glucose in human serum, plasma, urine, and cerebrospinal fluid. The technology is Enzymatic: Hexokinase- glucose-6 phosphate dehydrogenase. Detection is Bichromatic endpoint measurement- NADH (340 & 383 nm). Reaction Time is 120 seconds. Reagents are Liquid.
Here's a breakdown of the acceptance criteria and study details for the Glucose Flex® reagent cartridge (GLUC) based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria in terms of specific slope, intercept, or correlation coefficient ranges. However, the study aims to demonstrate substantial equivalence to the predicate device (GLU Flex® reagent cartridge) through split-sample comparison. The reported performance is presented as correlation statistics.
| Sample Type | Acceptance Criteria (Implied for Substantial Equivalence to Predicate) | Reported Device Performance (GLUC vs. Predicate GLU) |
|---|---|---|
| Serum/Plasma | (Not explicitly stated, but aiming for close to 1.00 slope and 0.00 intercept, with high correlation) | Slope: 1.01, Intercept: 0.01, Correlation Coefficient: 0.999 |
| Urine | (Not explicitly stated, but aiming for close to 1.00 slope and 0.00 intercept, with high correlation) | Slope: 1.01, Intercept: -1.05, Correlation Coefficient: 1.000 |
| Cerebrospinal Fluid | (Not explicitly stated, but aiming for close to 1.00 slope and 0.00 intercept, with high correlation) | Slope: 1.00, Intercept: -0.54, Correlation Coefficient: 1.000 |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- Serum/Plasma: 162 samples
- Urine: 64 samples
- Cerebrospinal Fluid: 70 samples
- Data Provenance: The data used was from "clinical patient samples." The country of origin is not specified, but given the submitter (Dade Behring Inc., Newark, DE) and the FDA submission, it can be inferred to be from the United States or a region with similar clinical practices. The data is retrospective as it involves "clinical patient samples" that were already collected and tested for the comparison.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For in vitro diagnostic devices like glucose test systems, the "ground truth" for the test set is typically established by comparing the device's results to a well-established, highly accurate reference method or a legally marketed predicate device. The document explicitly states a "split sample comparison" with the predicate device, implying the predicate device serves as the reference, but it doesn't mention human experts establishing ground truth for individual samples.
4. Adjudication Method for the Test Set
This information is not applicable/provided in the context of this type of study. Adjudication methods like 2+1 or 3+1 are typically used in imaging or clinical trial settings where human interpretation of results might vary. For a quantitative in vitro diagnostic device comparing its performance to a predicate, the comparison is direct numerical data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for devices that assist human readers (e.g., AI in radiology). The Glucose Flex® reagent cartridge is an in vitro diagnostic test system that provides a quantitative measurement directly, without human interpretation in the same way an imaging study would require.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is an inherently standalone device. The "algorithm" here is the enzymatic reaction and detection process within the clinical chemistry system. The performance presented (correlation statistics) represents the device's measurement capabilities directly, without a human-in-the-loop to interpret or modify its output as part of the primary measurement.
7. The Type of Ground Truth Used
The ground truth for this study was established using comparison to a legally marketed predicate device, specifically the "GLU Flex® reagent cartridge also on the Dimension® clinical chemistry system." The "split sample comparison" means that portions of the same patient samples were tested on both the new device (GLUC) and the predicate device (GLU), and the results were then statistically compared.
8. The Sample Size for the Training Set
The document does not provide information about a separate training set. For in vitro diagnostic devices like this, the development process might involve internal studies and method optimization, but a distinct "training set" with established ground truth as understood in machine learning contexts is typically not described in these 510(k) summaries for chemical analyzers. The provided data is for the performance evaluation that supports the 510(k) submission.
9. How the Ground Truth for the Training Set Was Established
As no training set is described, this information is not applicable/provided.
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'JUN - 2 2003
DADE BEHRING INC. P.O. Box 6101 Newark, DE 19714
Summary of Safety and Effectiveness Information
DADE BEHRING
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.
| Submitter's Name: | Lorraine PiestrakDade Behring Inc.P.O. Box 6101Newark, DE 19714-6101 |
|---|---|
| Date of Preparation: | April 8, 2003 |
| Name of Product: | Glucose Flex® reagent cartridge (GLUC) |
| FDA Classification Name: | Glucose Test System |
| Predicate Device: | Dimension® Glucose Method (K860021) |
Device Description:
Intended Use: The Glucose Flex® reagent cartridge (GLUC) for the Dimension® clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of glucose in human serum, plasma, urine, and cerebrospinal fluid.
Comparison to Predicate Device:
| Item | GLUC Flex® reagent cartridge | GLU Flex® reagent cartridge |
|---|---|---|
| Sample Type | Serum, plasma, urine, andcerebrospinal fluid | Serum, plasma, urine, andcerebrospinal fluid |
| Technology | Enzymatic:Hexokinase- glucose-6phosphate dehydrogenase | Enzymatic:Hexokinase- glucose-6-phosphate dehydrogenase |
| Detection | Bichromatic endpointmeasurement- NADH(340 & 383 nm) | Bichromatic endpointmeasurement- NADPH(340 & 383 nm) |
| Reaction Time | 120 seconds | 180 seconds |
| Reagents | Liquid | Tablets |
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Comments on Substantial Equivalence:
Split sample comparison between the GLUC Flex® reagent cartridge on the Dimension® clinical chemistry system and the GLU Flex® reagent cartridge also on the Dimension® clinical chemistry system gave the following correlation statistics, when tested with clinical patient samples:
| Sample Type | Slope | Intercept | Correlation Coefficient | n |
|---|---|---|---|---|
| Serum/Plasma | 1.01 | 0.01 | 0.999 | 162 |
| Urine | 1.01 | -1.05 | 1.000 | 64 |
| Cerebrospinal Fluid | 1.00 | -0.54 | 1.000 | 70 |
The Glucose Flex® reagent cartridge (GLUC) is substantially equivalent in Conclusion: principle and performance to the Glucose Flex® reagent cartridge (GLU) assay based on the split sample comparison discussed above.
Lorraine Pestiak
Lorraine Piestrak Regulatory Affairs and Compliance Manager Date: April 8, 2003
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES * USA" is arranged in a circular fashion around the bird image.
JUN - 2 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Lorraine Piestrak Regulatory Affairs and Compliance Manager Dade Behring Inc. P.O. Box 6101 Newark, DE 19714
Re: K031135
Trade/Device Name: Glucose Flex® reagent cartridge (GLUC) Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CFR Dated: April 8, 2003 Received: April 9, 2003
Dear Ms. Piestrak:
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).
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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,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications For Use Statement
Device Name: Glucose Flex® reagent cartridge (GLUC)
Indications for Use:
The Glucose Flex® reagent cartridge for the Dimension® clinical chemistry system is an in vitro diagnostic device intended to quantitatively measure glucose in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
Dan Cooper
Division Sign-Off
Division Sign-Off
Office of In Vitro Diagnostic Device i Evaluation and Safety
Lornanie Pestiace
Lórraine Piestrak Regulatory Affairs and Compliance Manager
April 8, 2003
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) 有限制的地球流量是最高质量的需要用品质量发展的机构机构合合同品质量需要
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-the-counter Use
(Optional format 1-2-96)
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.