What is the regulatory pathway for ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE?

510(k) clearance (submission type: Traditional).

What are the predicate devices for ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE?

Roche Glucose Hexokinase (K953847).

Who can help prepare an FDA 510(k) submission like ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE

Q: Who is the manufacturer of ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE?

Bayer Healthcare, Diagnostics Division filed the 510(k) submission for ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE (K042015).

Q: What is the FDA product code for ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE?

CGA. It is classified under 21 CFR 862.1345 as a Class 2 device in the Clinical Chemistry panel.

K042015 · Bayer Healthcare, Diagnostics Division · CGA · Sep 29, 2004 · Clinical Chemistry

Device Facts

Record ID	K042015
Device Name	ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE
Applicant	Bayer Healthcare, Diagnostics Division
Product Code	CGA · Clinical Chemistry
Decision Date	Sep 29, 2004
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1345
Device Class	Class 2
Attributes	Pediatric

Intended Use

The Bayer ADVIA 1650 Glucose Oxidase and Glucose Hexokinase II assays are in vitro diagnostic devices for use in the quantitative determination of glucose levels in human cerebrospinal fluid (CSF), serum, plasma, and urine on the ADVIA® 1650 Chemistry System. Such measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia and insulin overdose.

Device Story

The Bayer ADVIA Chemistry Glucose assays (Hexokinase and Oxidase) are in vitro diagnostic reagents used on the ADVIA 1650 Chemistry system. The device processes human CSF, serum, plasma, or urine samples. The Hexokinase assay uses a multi-component liquid reagent system (ATP, NAD, hexokinase, G6PDH) to catalyze glucose phosphorylation, resulting in NADH production proportional to glucose concentration. The Glucose Oxidase assay uses a single reagent (glucose oxidase, peroxidase, phenol, indicator) to produce a red-violet quinoneimine dye. Both assays measure absorbance changes via spectrophotometry. Used in clinical laboratory settings by trained personnel, the output is a quantitative glucose concentration value. This data assists clinicians in diagnosing and managing carbohydrate metabolism disorders. The device provides a diagnostic tool for monitoring glucose levels across multiple matrices.

Clinical Evidence

Bench testing only. Precision studies followed NCCLS EP5-A guidelines using CSF quality controls over 12 days (n=42-43), showing total imprecision CVs of 2.7-3.4%. Linearity was confirmed with ≤5% deviation across reportable ranges (0-700 mg/dL for Hexokinase; 0-750 mg/dL for Oxidase). Method comparison against the predicate using 55-56 patient CSF samples yielded R-values of 0.987 (Hexokinase) and 0.994 (Oxidase), with slopes of 1.026 and 0.973 respectively.

Technological Characteristics

In vitro diagnostic reagent assays for automated chemistry analyzer. Glucose Oxidase and Hexokinase II enzymatic methods. Analytical ranges: 0-750 mg/dL (Oxidase) and 0-700 mg/dL (Hexokinase).

Indications for Use

Indicated for quantitative glucose determination in human CSF, serum, plasma, and urine to diagnose and treat carbohydrate metabolism disorders, including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and insulin overdose.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Roche Glucose Hexokinase (K953847)

Related Devices

K011963 — ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY · Bayer Corp. · Nov 20, 2001
K052163 — ADVIA IMS GLUCOSE ASSAY · Bayer Healthcare, LLC · Oct 11, 2005
K062239 — GLUCOSE HK NEW FORMULATION TEST SYSTEM · Roche Diagnostics Corp. · Sep 11, 2006
K980026 — GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) · Trace America, Inc. · Mar 10, 1998
K990981 — GLUCOSE, HEXOKINASE (R1), MODEL GL101-01, GLUCOSE HEXOKINASE (R2), MODEL GL101-02 · A.P. Total Care, Inc. · May 25, 1999

Submission Summary (Full Text)

{0}------------------------------------------------ ## SEP 2 9 2004 ### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Glucose methods for ADVIA® 1650TM This summary of 510(k) safety and effectiveness information is being submitted in accordance This summary of 910(th) sales) and 1 and 1990 and 21 CFR 807.92. The assigned 510(k) number is: K642015 #### 1. Intended Use The Bayer ADVIA 1650 Glucose Oxidase and Glucose Hexokinase II assays are in vitro The Dayer AD TIA 1000 Of to occasion in the sure glucose levels in human cerebrospinal fluid (CSF), serum, plasma, and urine on the ADVIA® 1650 Chemistry System. Such measurements (CDF), seruin, phalma, and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypogleemia, idiopathic hypoglycemia and insulin overdose. #### 2. Predicate Device | Product Name | Reagent Part # | Calibrator Part # | |--------------------------|-------------------|-------------------| | Roche Glucose Hexokinase | 20763020 | 10759350 | #### Device / Method 3. | Product Name | Reagent Part #/ BAN # | Calibrator Part #/ BAN # | |-----------------------------------------|--------------------------|-----------------------------| | Bayer ADVIA® 1650 Glucose Hexokinase | B01-4597-01/ 04005536 | T03-1291-62/ 09784096 | | Bayer ADVIA® 1650 Glucose Oxidase | B01-4130-01/ 04903429 | T03-1291-62/ 09784096 | Imprecision | ADVIA 1650 Glucose Oxidase | | ADVIA 1650 Glucose Hexokinase II | | Roche Glucose Hexokinase | | |-------------------------------|---------------------|-------------------------------------|---------------------|--------------------------|---------------------| | Level (mg/dL) | Within-run CV(%) | Level (mg/dL) | Within-run CV(%) | Level (mg/dL) | Within-run CV(%) | | 58.0 | 1 | 60.2 | 1.2 | 31 | 1.6 | | 34.2 | 1.1 | 36.9 | 1.7 | 59 | 1.8 | {1}------------------------------------------------ | Specimen Type | Comparison System (x) | N | Regression Equation | Syx | r | Sample Range mg/dL | |-------------------------|--------------------------|----|------------------------|-----|-------|-----------------------| | Glucose (Oxidase) | Roche (On Integra) | 56 | $Y = 0.97x + 4.47$ | 7.6 | 0.994 | 37-530 | | Glucose (Hexokinase) | Roche (On Integra) | 55 | $Y = 1.03x - 1.25$ | 6.4 | 0.987 | 39-214 | ## Correlation (Y=ADVIA 1650, X=comparison system) Interfering Substances Interfering substances are not expected in cerebrospinal fluid samples. Analytical Range Glu-HKII: 0- 700 mg/dL Glu-Ox: 0- 750 mg/dL Carter 7/20/04 Date Andres Holle Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097 {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The logo is black and white. Public Health Service SEP 2 9 2004 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Mr. Andres Holle Manager, Regulatory Affairs Bayer Healthcare LLC. Diagnostics Division 511 Benedict Avenue Tarrytown, NY 10591 k042015 Re: R042019 Trade/Device Name: Glucose Hexokinase II assay for the ADVIA® 1650 Chemistry System Glucose Oxidase assay for the ADVIA® 1650 Chemistry System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CGA, CFR Dated: July 15, 2004 Received: August 5, 2004 Dear Mr. Holle: We have reviewed your Section 510(k) premarket notification of intent to market the device w & nowe 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 1 ou may, diereleve, marrer of the Act include requirements for annual registration, listing of general controls proficiouring 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 it may or subject to back of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA can oo louits in there announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be devised alat termination that your device complies with other requirements of the Act that I Drederal statutes and regulations administered by other Federal agencies. You must or any I odoral statutes and regirements, including, but not limited to: registration and listing (21 {3}------------------------------------------------ #### Page 2 This letter will allow you to begin marketing your device as described in your Section 510(k) I ms lotter will and will your to be finding of substantial equivalence of your device to a legally premaince noticate 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 fou don't on the promotion and advertising of your device, please contact the Office of of quebelle on the preside 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, Jean M. Cooper, MS, DVM. Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Indications for Use 510(k) Number (if known): KOL 2015 Device Name: Glucose Hexokinase II assay for the ADVIA® 1650 Chemistry System Indications For Use: The Bayer ADVIA® 1650 Glucose Hexokinase II assay is an in vitro diagnosic device The Bayer ADVAN® TUSO Glaoooo Hoxokhabo in human cerebrospinal fluid (CSF), for use in the first for use in the quantitutive actornination on the ADVIA® 1650 Chemistry system. serum, plasma (illinian nopalin), the diagnosis and treatment of carbohydrate Such measurements are about the claghester the clayments, idiopathic hypoglycemia and insulin overdose. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (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) Albert Cert Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and 510(k) k042015 {5}------------------------------------------------ # Indications for Use 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: Glucose Oxidase assay for the ADVIA® 1650 Chemistry System Indications For Use: The Bayer ADVIA® 1650 Glucose Oxidase assay is an in vitro diagnostic device for use The Bayer ADVIA® 7000 Glucose in human cerebrospinal fluid (CSF), serum, in the quantitative determination of glucose in human cerebrospinal fluid (CSF), serum, in the quantitative determination of groups in haman seems . Such measurements are plasma and urine on the ADVIA® 1650 Chemistry system. Such measurements are plasma and urne on the ADVIA® 1000 Onehabelism disorders including used in the diagnosis and treatment of carbohydrate and insulin used in the diagnosis and treathent of Sarbonyards in the months and insulin overdose. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (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) Alberto Lutz Division Sign-Off Page 1 of ____________________________________________________________________________________________________________________________________________________________________ Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K042015