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.

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.

AI/ML Overview

This submission pertains to the GenChem Glucose Oxidase Reagent for the quantitative determination of glucose. The study evaluates the device's performance against predefined criteria across various metrics.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance
Precision/Reproducibility
Serum Glucose (60mg/dL)	Low %CV for within-run and total imprecision	Within Run: 1.4%CV; Total: 2.1%CV
Serum Glucose (220mg/dL)	Low %CV for within-run and total imprecision	Within Run: 0.6%CV; Total: 1.1%CV
Serum Glucose (387mg/dL)	Low %CV for within-run and total imprecision	Within Run: 0.6%CV; Total: 1.3%CV
CSF Glucose (57mg/dL)	Low %CV for within-run and total imprecision	Within Run: 1.2%CV; Total: 2.4%CV
CSF Glucose (33mg/dL)	Low %CV for within-run and total imprecision	Within Run: 1.9%CV; Total: 4.1%CV
Urine Glucose (24mg/dL)	Low %CV for within-run and total imprecision	Within Run: 2.9%CV; Total: 5.8%CV
Urine Glucose (315mg/dL)	Low %CV for within-run and total imprecision	Within Run: 1.0%CV; Total: 1.6%CV
ORDAC Serum Glucose (557mg/dL)	Low %CV for within-run and total imprecision	Within Run: 1.5%CV; Total: 1.8%CV
ORDAC Serum Glucose (770mg/dL)	Low %CV for within-run and total imprecision	Within Run: 0.9%CV; Total: 1.5%CV
Linearity/Assay Reportable Range	Slope close to 1, Intercept close to 0, high R-squared	Slope: 1.012, Intercept: 0.1.97, R²: 1.000
Normal Range (All Specimens)	Accurate detection within 5 to 450 mg/dL	5 to 450 mg/dL (0.3 to 25 mmol/L)
ORDAC Range (All Specimens)	Accurate detection within 450 to 900 mg/dL	450 to 900 mg/dL (25 to 50 mmol/L)
Sensitivity	Value <= 5.0 mg/dL	Observed: 0.255 mg/dL (claimed: 5.0 mg/dL)
Analytical Specificity	No adverse effect from interfering substances	Hemoglobin (up to 500 mg/dL), Bilirubin (up to 20 mg/dL), Lipemia (up to 1800 mg/dL) showed no adverse effect.
Patient Comparison	Strong correlation with predicate (slope close to 1, intercept close to 0, high R²)	Serum: Slope 1.011, Intercept -1.2, R² 0.999 Plasma: Slope 1.000, Intercept 1.0, R² 0.999 Urine: Slope 1.012, Intercept -2.1, R² 0.999 CSF: Slope 0.973, Intercept 1.0, R² 0.999

2. Sample Sizes Used for the Test Set and Data Provenance

Precision/Reproducibility: Control sera and spiked urine pools were each assayed in triplicate, two times per day over 10 days. This means for each of the 9 samples (7 standard + 2 ORDAC), there were 60 individual measurements (3 tests/day * 2 times/day * 10 days).
Linearity/Assay Reportable Range: Commercially available linearity standards were analyzed in triplicate. No specific number of standards or replicates beyond "triplicate" is given.
Sensitivity: 21 replicates of a diluted serum control were performed.
Analytical Specificity: Stock solutions of interfering substances were prepared and added to a 96 mg/dL glucose stock sample. No specific number of samples or replicates is mentioned beyond the description of the preparation of a test and control stock.
Patient Comparison:
- Serum: 79 adult patient specimens
- Plasma: 80 adult patient specimens
- Urine: 81 adult patient specimens (spiked with glucose)
- CSF: 45 adult patient specimens
- Data Provenance: The document does not explicitly state the country of origin. The study appears to be prospective as it involves the collection and assaying of patient specimens and the generation of new experimental data on the device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

There were no experts used to establish a ground truth for the test set in this study. The ground truth for comparative effectiveness and performance in this context is the measurement obtained from the predicate device (Beckman Glucose Reagent for the CX3) or established laboratory methods (e.g., for linearity standards, sensitivity).

4. Adjudication Method for the Test Set

No adjudication method was used for the test set. The study compares the performance of the new device to a predicate device and established laboratory guidelines for precision, linearity, and sensitivity. Discrepancies would be identified through statistical analysis (e.g., linear regression for patient comparison, %CV for precision) rather than expert adjudication.

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 study concerns the performance of an in vitro diagnostic reagent, not a system that involves human interpretation of images or other data typically associated with MRMC studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, this was a standalone study. The device (Glucose Oxidase Reagent) is a chemical reagent used on an automated analyzer (Beckman SYNCHRON CX3® System). Its performance is evaluated intrinsically through laboratory tests (precision, linearity, sensitivity, specificity) and comparison to a predicate reagent, without human intervention in the interpretation of the results themselves. The results are quantitative values.

7. The Type of Ground Truth Used

The ground truth used in this study is primarily based on:

Reference Methods/Predicate Device: For patient comparison, the measurements from the predicate device (Beckman Glucose Reagent) on the same SYNCHRON CX3® System served as the reference.
Established Analytical Standards: For linearity, commercially available linearity standards with known concentrations were used.
Statistical Calculation: For sensitivity, the ground truth was derived from the statistical calculation of three standard deviations of a diluted serum control.
Known Concentrations: For analytical specificity, interfering substances at specified concentrations were added to a stock sample with a known glucose level.

Essentially, the ground truth is derived from existing, validated analytical methods and materials.

8. The Sample Size for the Training Set

There is no mention of a "training set" in the context of this submission. The device is a chemical reagent, not a machine learning algorithm that requires a training phase.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there was no training set.

Summary

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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:

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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

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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)	< 0.5 g/day	< 2.8 mmol/day
CSF	40 - 70 mg/dL	2.22 - 3.89 mmol/L

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is enclosed in a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 27 2004

C.C. Allain, Ph.D. Chief Scientific Officer GenChem, Inc. 471 W. Lambert Road, Suite 107 Brea, CA 92821

Re: K040974

Trade/Device Name: Glucose Oxidase Reagent Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CGA Dated: October 15, 2004 Received: October 15, 2004

Dear Dr. Allain:

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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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) rins leter will and my you w obgen finding of substantial equivalence of your device to a legally preshated 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, r you don't 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 Tou may 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,

Cornelia B. Lorke

Cornelia B. Rooks, MA Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number: K040974

Device Name: Glucose Oxidase Reagent

Indications For Use:

Prescription Use X_

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE

IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

ffice of In Vitro Diagn Device Evaluation and

51000 K040974

Regulation Number and Section

§ 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.