(257 days)
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No
The device is a chemical reagent for a laboratory analyzer and the description focuses on chemical composition and analytical performance metrics, not AI/ML algorithms.
No.
The device is a reagent used for the quantitative determination of glucose, which aids in diagnosis rather than treating a disease or condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "to aid in the diagnosis of diabetes, liver disease and certain endocrine disorders." This directly indicates its role in diagnosis.
No
The device description explicitly states it is a "solution containing sufficient Glucose Oxidase, surfactants and other ingredients," which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of glucose in serum, plasma, urine and cerebrospinal fluid". These are biological specimens taken from the human body.
- Purpose: The purpose is "to aid in the diagnosis of diabetes, liver disease and certain endocrine disorders". This is a diagnostic purpose.
- Device Description: The device is a "solution containing sufficient Glucose Oxidase, surfactants and other ingredients necessary for optimum system operation". This is a reagent designed to react with a biological sample to produce a measurable result.
- Performance Studies: The document includes performance studies like precision, linearity, sensitivity, analytical specificity, and patient comparison, which are typical for IVD devices to demonstrate their analytical and clinical performance.
All these characteristics align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
The GenChem Glucose Oxidase Reagent is for the quantitative determination of glucose in serum, plasma, urine and cerebrospinal fluid on the Beckman SYNCHRON CX3® System to aid in the diagnosis of diabetes, liver disease and certain endocrine disorders.
Product codes (comma separated list FDA assigned to the subject device)
CGA
Device Description
The Device is a solution containing sufficient Glucose Oxidase, surfactants and other ingredients necessary for optimum system operation on the Beckman CX3® Analyzer.
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)
Precision/Reproducibility: Within-Day and Day-to-Day precision was determined according to NCCLS EP5-A. Control sera and spiked urine pools were each assayed in triplicate, two times per day over 10 days on a SYNCHRON CX3® System. Estimates of within run and total imprecision were calculated as described in NCCLS publication EP3-T.
Linearity/assay reportable range: Linearity was performed according to NCCLS Guideline EP6-A. Commercially available linearity standards ranging from 0 to 800 mg/dL were analyzed in triplicate on the Beckman SYNCHRON CX3® and the results analyzed by the Least Squares method. The results gave a slope of 1.012 with an intercept of 0.1.97, a standard error of estimate of 6.83 and r^2 = 1.000. Samples exceeding these limits should be diluted with normal saline and reanalyzed. Multiply the result by the appropriate dilution factor.
Analytical Specificity: Determined according to NCCLS EP7-A. Hemoglobin levels up to 500 mg/dL, Bilirubin levels up to 20 mg/dL, and Lipemia levels up to 1800 mg/dL were tested and did not show any adverse effect on a stock sample with a glucose level of 96 mg/dL. Stock solutions of the substance to be tested were prepared at 20x concentrations and 0.5 ml of this stock was placed in a 10 ml volumetric flask and made up to volume with the base pool. The control stock was prepared similarly but with water as the diluent. Heparin, Lithium Heparin, Ammonium Heparin, and EDTA, sodium fluoride and potassium oxalate are acceptable anticoagulants.
Patient Comparison: Serum, plasma and CSF specimens, and urine specimens spiked with glucose were collected from adult patients and assayed using GenChem and Beckman glucose reagents on a SYNCHRON CX3® System. Results were compared by least squares linear regression and the following statistics were obtained.
Serum: N=79, Range (mg/dL) = 29-341, Intercept = -1.2, Slope = 1.011, R2 Value = 0.999
Plasma: N=80, Range (mg/dL) = 30-350, Intercept = 1.0, Slope = 1.000, R2 Value = 0.999
Urine: N=81, Range (mg/dL) = 1-359, Intercept = -2.1, Slope = 1.012, R2 Value = 0.999
CSF: N=45, Range (mg/dL) = 3-186, Intercept = 1.0, Slope = 0.973, R2 Value = 0.999
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SENSITIVITY: The sensitivity of this method is 5.0 mg/dL and was documented through the repetitive assay of a diluted serum control. The observed sensitivity limit, calculated as three standard deviations of a 21 replicate within run precision study, is 0.255 mg/dL and is below the claimed limit of 5.0 mg/dL.
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.
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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§ 862.1345 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
510(k) SUMMARY K040974
1.0 Submitted By:
C.C. Allain, Ph.D. Chief Scientific Officer GenChem, Inc. 471 W. Lambert Road, Ste 107 Brea, CA 92821 Telephone: (714) 529-7125 FAX: (714) 529-3339
June 1, 2004 2.0 Date of Preparation:
Regulatory Information: 3.0
- 3.1 Regulation section:
- 21 CFR § 862.1345, Glucose Oxidase Reagent for Beckman 3.2 Synchron CX3® System
- Clasification : Class II 3.3
- 3.4 Product Code: CGA
- 3.5 Panel: Clinical Chemistry (75)
4.0 Device Description:
The Device is a solution containing sufficient Glucose Oxidase, surfactants and other ingredients necessary for optimum system operation on the Beckman CX3® Analyzer.
Substantial Equivalence Information: 5.0
- a. Predicate Device Name: Beckman Glucose Reagent for the CX3.
- b. Predicate K Number: K761060
- Comparison with Predicate: Both Reagents are similar in design, function and ﻦ chemical principle as well as ingredient composition and concentration.
- Performance Characteristics: All studies were performed on the Beckman 6.0 CX3 Synchron Analyzer.
- 6.1 Precision/Reproducibility: Within-Day and Day-to-Day precision was determined according to NCCLS EP5-A. Results are summarized below:
1
Control sera and spiked urine pools were each assayed in triplicate, two times per day over 10 days on a SYNCHRON CX3® System. Estimates of within run and total imprecision were calculated as described in NCCLS publication EP3-T.
Precision of Glucose Recoveries in (mg/dL)
| Sample | Within Run | Total | ||||
|---|---|---|---|---|---|---|
| n | mean | SD | %CV | SD | %CV | |
| Serum1 | 60 | 51 | 0.7 | 1.4 | 1.1 | 2.1 |
| Serum 2 | 60 | 220 | 1.3 | 0.6 | 2.3 | 1.1 |
| Serum 3 | 60 | 387 | 2.3 | 0.6 | 5.1 | 1.3 |
| CSF 1 | 60 | 57 | 0.7 | 1.2 | 1.4 | 2.4 |
| CSF 2 | 60 | 33 | 0.6 | 1.9 | 1.4 | 4.1 |
| Urine 1 | 59 | 24 | 0.7 | 2.9 | 1.4 | 5.8 |
| Urine 2 | 60 | 315 | 3.2 | 1.0 | 5.1 | 1.6 |
Two additional control sera were spiked with glucose and assayed as described above using ORDAC sample dilution.
Precision of ORDAC Glucose Recoveries (mg/dL)
| Within Run | Total | |||||
|---|---|---|---|---|---|---|
| Sample | n | mean | SD | %CV | SD | %CV |
| Serum 1 | 60 | 557 | 8.1 | 1.5 | 10.0 | 1.8 |
| Serum 2 | 60 | 770 | 7.1 | 0.9 | 11.8 | 1.5 |
Linearity/assay reportable range: 6.2
Linearity was performed according to NCCLS Guideline EP6-A. Commercially available linearity standards ranging from 0 to 800 mg/dL were analyzed in triplicate on the Beckman SYNCHRON CX3® and the results analyzed by the Least Squares method. The results gave a slope of 1.012 with an intercept of 0.1.97, a standard error of estimate of 6.83 and r2 = 1.000. Samples exceeding these limits should be diluted with normal saline and reanalyzed. Multiply the result by the appropriate dilution factor.
| Specimens | range | Conventional units | SI Units |
|---|---|---|---|
| All | Normal | 5 to 450 mg/dL | 0.3 to 25 mmol/L |
| All | ORDAC | 450 to 900 mg/dL | 25 to 50 mmol/L |
6.3 SENSITIVITY:
The sensitivity of this method is 5.0 mg/dL and was documented through the repetitive assay of a diluted serum control. The observed sensitivity limit, calculated as three standard deviations of a 21 replicate within run
2
precision study, is 0.255 mg/dL and is below the claimed limit of 5.0 mg/dL.
Analytical Specificity: 6.4
Determined according to NCCLS EP7-A. Hemoglobin levels up to 500 mg/dL, Bilirubin levels up to 20 mg/dL, and Lipemia levels up to 1800 mg/dL were tested and did not show any adverse effect on a stock sample with a glucose level of 96 mg/dL. Stock solutions of the substance to be tested were prepared at 20x concentrations and 0.5 ml of this stock was placed in a 10 ml volumetric flask and made up to volume with the base pool. The control stock was prepared similarly but with water as the diluent. Heparin, Lithium Heparin, Ammonium Heparin, and EDTA, sodium fluoride and potassium oxalate are acceptable anticoagulants.
Patient Comparison 7.0
Serum, plasma and CSF specimens, and urine specimens spiked with glucose were collected from adult patients and assayed using GenChem and Beckman glucose reagents on a SYNCHRON CX3® System. Results were compared by least squares linear regression and the following statistics were obtained.
| VALUE | SERUM | PLASMA | URINE | CSF |
|---|---|---|---|---|
| Intercept | -1.2 | 1.0 | -2.1 | 1.0 |
| Slope | 1.011 | 1.000 | 1.012 | 0.973 |
| R2 Value | 0.999 | 0.999 | 0.999 | 0.999 |
| N | 79 | 80 | 81 | 45 |
| Range (mg/dL) | 29-341 | 30 - 350 | 1 - 359 | 3 - 186 |
Expected Values/ Reference Range: 8.0
The expected values for glucose are listed below. Use these ranges only as guides. Each laboratory should establish its own reference ranges.
| Reference Ranges3 | |||
|---|---|---|---|
| Specimens | Conventional Units | SI Units | |
| Serum/Plasma | 70 - 105 mg/dL | 3.89 - 5.83 mmol/L | |
| Urine (Random) | 1 - 15 mg/dL | 0.1 - 0.8 mmol/L | |
| Urine (Timed) |