Who else makes this device?

Name: Advia® Chemistry GLUH_3 Glucose Hexokinase_3 Reagents
Brand: Advia® Chemistry GLUH_3 Glucose Hexokinase_3 Reagents

Clinical Chemistry › Test SystemsHexokinase, Glucose

Advia® Chemistry GLUH_3 Glucose Hexokinase_3 Reagents

ADVIA Chemistry Glucose Hexokinase 3 is an in vitro diagnostic reagent for measuring glucose on the ADVIA 1650 Chemistry system. It accepts human serum, plasma, urine and cerebrospinal…

Registry build 21.09.26

ADVIA Chemistry Glucose Hexokinase 3 is an in vitro diagnostic reagent for measuring glucose on the ADVIA 1650 Chemistry system. It accepts human serum, plasma, urine and cerebrospinal fluid. Glucose measurements support diagnosis and treatment of carbohydrate-metabolism disorders, including diabetes and hypoglycemia.

The assay uses two reagents. The sample first mixes with a buffered reagent containing ATP and NAD, providing an initial absorbance reading. Addition of the second reagent initiates enzymatic glucose conversion; the change in absorbance at 340 and 410 nm is proportional to glucose concentration.

Listed Item

Glucose – ADVIA Chem. – RGT – 6×660/6×470 tests

Calibration and Range

The method uses hexokinase and glucose-6-phosphate dehydrogenase enzymes. Its reportable range is 4 to 700 mg/dL. Calibration uses the Siemens Chemistry Calibrator, with traceability to NIST standard reference material 965a.

2manufacturers in China registered for this device type

1catalogue number

2510(k) clearances naming this product code

2recalls on this code

Who Else Makes It

Concentrated in Guangdong (1), Jiangsu (1).

Chinese manufacturers registered for FDA product code CFR
Manufacturer	City	Province	Registered as	Device types
Shenzhen Mindray BIO-Medical Electronics Co., Ltd.	Shenzhen	Guangdong	Specification developer	61
Roche Diagnostics (Suzhou) Ltd.	Suzhou	Jiangsu	Manufacturer	3

Record

Regulatory record for Advia® Chemistry GLUH_3 Glucose Hexokinase_3 Reagents
Listed by	Siemens Healthcare Diagnostics Inc, United States
FDA product code	CFR
Device type	Hexokinase, Glucose
Device class	Class 2
Regulation	21 CFR 862.1345
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
510(k)	K101854
Record published	2016-09-24
Record revised	2023-07-06 (version 6)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	lot or batch number, expiry date
Storage	Special storage condition: Do not freeze; Storage environment temperature 2 to 8 °C

Catalogue Numbers

Catalogue numbers for Advia® Chemistry GLUH_3 Glucose Hexokinase_3 Reagents
Catalogue number	Size	Status
10335891		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Gluc-HK	Randox Laboratories Limited	6
Glucoquant GlucoseHK	Roche Diagnostics Gmbh	3
Glucose HK	Roche Diagnostics Gmbh	3
AU	Beckman Coulter, Inc.	3
Teco Diagnostics Glucose (Hexokinase) Reagent Set	Teco Diagnostics	2
Yumizen C1200 Glucose HK	Horiba ABX SAS	2
Architect	Abbott Laboratories	2
Alinity	Abbott Medical	2
Teco Diagnostics Glucose (Hexokinase) Liquid Reagent	Teco Diagnostics	2
Atellica CH GluH_3	Siemens Healthcare Diagnostics Inc	2
Pointe Scientific, Inc.	Horiba Instruments Incorporated	2
Architect	Abbott Medical	2

Showing 12 of 43. All products under Hexokinase, Glucose

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K120681	2012-05-15
K101854	2011-03-07

Recalls

2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2017-06-29	Class II	Device Design	Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely depressed results.	19,245	2020-04-23
2017-06-29	Class II	Device Design	Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely depressed results.	80,466	2020-04-23

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.