(178 days)
No
The device description details a standard enzymatic assay for glucose measurement, and there is no mention of AI or ML in the text.
No.
The device is an in vitro diagnostic reagent used for the quantitative determination of glucose; it is not intended for therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the N-ASSAY Glu-UL Reagent is for "quantitative determination of glucose... in the diagnosis and treatment of diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma." It also states "For in vitro diagnostic use only."
No
The device description clearly states it is a "reagent," which is a chemical substance used in a laboratory test. This is a physical component, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostic use only." This is the primary indicator that the device is intended for use outside of a living organism to examine specimens from the human body for the purpose of providing information for the diagnosis, monitoring, or treatment of a disease or condition.
Furthermore, the intended use describes the quantitative determination of glucose in various bodily fluids (serum, plasma, urine, and cerebrospinal fluid) for the diagnosis and treatment of specific medical conditions related to glucose levels. This aligns perfectly with the definition of an IVD.
N/A
Intended Use / Indications for Use
The intended use for the N-ASSAY Glu-UL Reagent is for the quantitative determination of glucose in serum, plasma, urine, and cerebrospinal fluid in the diagnosis and treatment of diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. For in vitro diagnostic use only.
Product codes
CFR
Device Description
The N-ASSAY Glu-UL reagent is based on an enzymatic hexokinase/glucose-6phosphate dehydrogenase method, shows good correlation with similar glucose reagents, practically no interference by coexistent substances, high sensitivity with good reproducibility, wide assay range, and is a convenient ready-to-use liquid type reagent.
In this method, serum D-glucose is phosphorylated by hexokinase (HK) in the presence of adenosine triphosphate (ATP) to produce glucose-6-phosphate (G-6-P) and adenosine diphosphate (ADP). Glucose-6-phosphate dehydrogenase (G-6-PDH) specifically oxidizes G-6-P to 6-Phosphogluconate with the concurrent reduction of nicotinamide adenine dinucleotide phosphate (NADP) to nicotinamide adenine dinucleotide phosphate reduced (NADPH). The NADPH produced absorbs light at 340 nm (main) and 405 nm (sub) and can be detected spectrophotometrically. The increase in absorbance measured at 340 nm (main) and 405 (sub), due to the formation of the NADPH, is directly proportional to the glucose concentration in the sample.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
In comparison studies against the predicate assay, a correlation coefficient of 0.99587 and a regression equation y = 0.8861 x + 4.7012 was obtained with serum samples. Precision studies indicate acceptable values can be obtained on a day to day basis. The minimum detectable level of this method is 1 mg/dl. The N-ASSAY Glu UL reagent is linear to 1,000 mg/dl.
For urine and CSF samples, the liquid Crestat N-ASSAY Glu-UL Reagent was compared to the Boehringer Mannheim Glucose assay (K812303) which is also based on an enzymatic hexokinase method. Using urine samples, a correlation coefficient of 0.9989 and a regression equation y = 1.038 x + 1.528 was obtained. Using CSF samples, a correlation coefficient of 0.9923 and a regression equation of y = 1.080 x + -1.233 was obtained. The limit of quantitation is 0.3 mg/dl.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
correlation coefficient of 0.99587 (serum samples), regression equation y = 0.8861 x + 4.7012 (serum samples), minimum detectable level 1 mg/dl, linear to 1,000 mg/dl (glucose concentration).
correlation coefficient of 0.9989 (urine samples), regression equation y = 1.038 x + 1.528 (urine samples).
correlation coefficient of 0.9923 (CSF samples), regression equation y = 1.080 x + -1.233 (CSF samples), limit of quantitation is 0.3 mg/dl.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
SEP 3 1998
CRESTAT DIAGNOSTICS, INC.
25549 Adams Avenue Murrieta, CA 92562
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
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.
The assigned 510(k) number is:
March 2, 1998 Date:
Submitted by: Colin Getty KAMIYA BIOMEDICAL COMPANY 910 Industry Drive, Seattle WA 98188 TEL: 206-575-8068; FAX: 206-575-8094
Crestat Diagnostics, Inc. For: 25549 Adams Avenue Murrieta. CA 92562
N-ASSAY Glu-UL (Glucose Assay Reagent) Product:
Blood qlucose determinations are one of the most frequently performed clinical chemistry laboratory procedures and are commonly used as an aid in the diagnosis and treatment of diabetes. Early methods were based on the reducing properties of glucose: however, these methods are susceptible to positive errors caused by nonglucose-reducing substances present in normal blood. Chemical methods using otoluidine offered improved specificity, but other sugars not normally present in serum can also react with o-toluidine and be a potential source of error. Enzymatic methods using purified enzymes which act on glucose provided greater specificity.
The N-ASSAY Glu-UL reagent is based on an enzymatic hexokinase/glucose-6phosphate dehydrogenase method, shows good correlation with similar glucose reagents, practically no interference by coexistent substances, high sensitivity with good reproducibility, wide assay range, and is a convenient ready-to-use liquid type reagent.
In this method, serum D-glucose is phosphorylated by hexokinase (HK) in the presence of adenosine triphosphate (ATP) to produce glucose-6-phosphate (G-6-P) and adenosine diphosphate (ADP). Glucose-6-phosphate dehydrogenase (G-6-PDH) specifically oxidizes G-6-P to 6-Phosphogluconate with the concurrent reduction of nicotinamide adenine dinucleotide phosphate (NADP) to nicotinamide adenine dinucleotide phosphate reduced (NADPH). The NADPH produced absorbs light at 340 nm (main) and 405 nm (sub) and can be detected spectrophotometrically. The increase in absorbance measured at 340 nm (main) and 405 (sub), due to the formation of the NADPH, is directly proportional to the glucose concentration in the sample.
1
CRESTAT DIAGNOSTICS, INC.
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS (Continued)
The safety and effectiveness of the liquid Crestat N-ASSAY Glu-UL Reagent is demonstrated by its substantial equivalence to the Medical Analysis Systems Glucose liguid reagent (K853464) which is also based on an enzymatic hexokinase/glucose-6phosphate dehydrogenase method. Both test systems are intended to quantitatively measure glucose in human serum.
In comparison studies against the predicate assay, a correlation coefficient of 0.99587 and a regression equation y = 0.8861 x + 4.7012 was obtained with serum samples. Precision studies indicate acceptable values can be obtained on a day to day basis. The minimum detectable level of this method is 1 mg/dl. The N-ASSAY Glu UL reagent is linear to 1,000 mg/dl.
For urine and CSF samples, the liquid Crestat N-ASSAY Glu-UL Reagent was compared to the Boehringer Mannheim Glucose assay (K812303) which is also based on an enzymatic hexokinase method. Using urine samples, a correlation coefficient of 0.9989 and a regression equation y = 1.038 x + 1.528 was obtained. Using CSF samples, a correlation coefficient of 0.9923 and a regression equation of y = 1.080 x + -1.233 was obtained. The limit of quantitation is 0.3 mg/dl.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the HHS logo, which consists of a stylized caduceus with three snakes intertwined around a staff. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the logo. The seal is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 3 1998
Crestat Diagnostics, Inc. Colin Getty C/O KAMIYA Biomedical Company 910 Industry Drive Seattle, Washington, 98188
K980883 Re : N-ASSAY Glu-UL Requlatory Class: II Product Code: CFR June 30, 1998 Dated: Received: July 2, 1998
Dear Mr. Getty:
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 The general controls provisions of the Act of the Act. include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 Requlations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 requlation may result in regulatory In addition, FDA may publish further announcements action. 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 requlations.
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Page 2
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 regulation (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
Enclosure ... ...
4
INDICATIONS FOR USE STATEMENT
12980883 510(k) Number (if known): __
N-ASSAY Glu-UL (Glucose Assay Reagent) Device Name:
Indications For Use:
The intended use for the N-ASSAY Glu-UL Reagent is for the quantitative determination of glucose in serum, plasma, urine, and cerebrospinal fluid in the diagnosis and treatment of diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. For in vitro diagnostic use only.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cun
(Division Sign-Off) Division of Clinical Laborato 510(k) Number .
Prescription Use
(Per 21 CFR 801.109)
OR
5
Over-The-Counter Use
Optional Format 1-2-96)