(84 days)
704035, 16-UV, 857429
BMD Glucose/HK Reagent, product no. 704035, Sigma Glucose (HK) Reagent, procedure no. 16-UV, BMD Glucose/HK Reagent, product for. 857429
No
The device description and performance studies focus on enzymatic reactions and standard analytical procedures, with no mention of AI or ML.
No.
The device is a reagent used for quantitative determination of glucose, which is a diagnostic purpose, not a therapeutic one.
Yes
Explanation: The device is a reagent for the quantitative determination of glucose in bodily fluids, which is used to aid in the diagnosis of conditions like diabetes.
No
The device is a reagent, which is a chemical substance used in a chemical reaction to detect, measure, or produce other substances. It is a physical component, 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, cerebrospinal fluid and urine." These are biological specimens taken from the human body.
- Device Description: The description details a chemical reagent used to perform an enzymatic reaction on these biological specimens to measure a specific analyte (glucose).
- Performance Studies: The performance studies describe testing the reagent's effectiveness using human specimens (serum, plasma, urine, CSF) and comparing results to other similar reagents.
- Predicate Devices: The mention of predicate devices (BMD Glucose/HK Reagent, Sigma Glucose (HK) Reagent) which are also IVDs further supports this classification.
- Intended User/Care Setting: While it mentions manual procedures or clinical analyzers, the context of measuring glucose in biological fluids points to a clinical laboratory or healthcare setting where diagnostic testing is performed.
All of these factors align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
HiChem Glucose/HK Reagent (product no. 70007) is for the quantitative determination of glucose in serum, plasma, cerebrospinal fluid and urine.
Product codes
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Device Description
The HiChem Glucose/HK Reagent determines glucose by enzymatic phosphorylation using ATP in the presence of hexokinase. The extent of this reaction, and the quantity of glucose in the specimen, is determined through the measurement of the resulting glucose-o-phosphate by producing NADH in the presence of glucose-o-phosphate dehydrogenase.
The HiChem Glucose Reagent is intended to be used either as a manual procedure or on clinical analyzers which ean automate the required manipulations. The reagent is supplied as two liquid-stable components which are combined, either before or during use, in the approximate ratio of 1 part Glucose Enzyme Reagent and 8 parts Glucose Reagent Buffer. The Glucose Enzyme Reagent can also be used as a start reagent and combined with the Reagent Buffer following sample addition.
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)
The effectiveness of the manual procedure is shown by the recovery of linearity standards, the precision of control recoveries, a comparison of servin and plasma recoveries to the Sigma Glucose (HK) Reagent, a comparison of urine and CSF recoveries to the BMD Glucose/HK Reagent and validation of the chemical additive and reconstituted stability claims.
The recovery of glucose using HiChem Glucose/HK Reagent as a manual method is linear to at least 500 mg/dL.
The effectiveness of the automated Hitachi 704 procedure is shown by the recovery of linearity standards, the precision of control recoveries, comparison of patient specimen recoveries to the BMD Glucose/HK Reagent and the recovery of serum controls over the claimed calibration stability period.
The recovery of glucose using HiChem Glucose/HK Reagent as an automated method is linear to at least 1000 mg/dL.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Manual Method:
(HiChem Results) = 2.1 mg/dL + 0.9769 x (Standard Value), r = 0.9999, Sy.x = 2.6 mg/dL.
Precision for manual method:
Low serum control: n=30, mean=95.6 mg/dL, within run SD=0.89 mg/dL, total SD=2.77 mg/dL
High serum control: n=30, mean=296.1 mg/dL, within run SD=2.78 mg/dL, total SD=4.41 mg/dL
Low urine pool: n=30, mean=18.7 mg/dL, within run SD=0.75 mg/dL, total SD=1.50 mg/dL
High urine pool: n=30, mean=274.2 mg/dL, within run SD=2.10 mg/dL, total SD=6.95 mg/dL
Low CSF control: n=30, mean=59.8 mg/dL, within run SD=0.78 mg/dL, total SD=2.9 mg/dL
High CSF control: n=30, mean=41.9 mg/dL, within run SD=1.11 mg/dL, total SD=2.8 mg/dL
Serum/Plasma Comparison (n=80): (HiChem Results) = 0.2 mg/dL + 1.013 x (Sigma Results), r = 0.999, Sy.x = 2.3 mg/dL.
Urine Comparison (n=36): (HiChem Results) = 4.1 mg/dL + 0.944 x (BMD Results), r = 0.998, Sy.x = 5.58 mg/dL.
CSF Comparison (n=37): (HiChem Results) = 1.9 mg/dL + 0.972 x (BMD Results), r = 0.997, Sy.x = 1.8 mg/dL.
Automated Method:
Sy.x = 2.7 mg/dL. (HiChem Results) = 1.4 mg/dL + 0.986 × (Standard Value), r = 1.0000,
Precision for automated method:
Low serum control: n=60, mean=86.5 mg/dL, within run SD=0.68 mg/dL, total SD=1.07 mg/dL
Mid. serum control: n=60, mean=294.0 mg/dL, within run SD=1.18 mg/dL, total SD=2.09 mg/dL
High serum control: n=60, mean=577.5 mg/dL, within run SD=2.18 mg/dL, total SD=5.39 mg/dL
Low urine pool: n=60, mean=23.5 mg/dL, within run SD=0.67 mg/dL, total SD=0.77 mg/dL
High urine pool: n=60, mean=669.5 mg/dL, within run SD=2.41 mg/dL, total SD=4.88 mg/dL
Low CSF control: n=58, mean=33.6 mg/dL, within run SD=1.02 mg/dL, total SD=1.13 mg/dL
High CSF control: n=59, mean=57.2 mg/dL, within run SD=0.78 mg/dL, total SD=1.26 mg/dL
Serum/Plasma Comparison (n=105): (HiChem Results) = -1.1 mg/dL + 1.004 × (BMD Results), r = 0.999, sy.x = 1.61 mg/dL
Urine Comparison (n=56): (HiChem Results) = -1.4 mg/dL + 0.989 × (BMD Results), r = 0.999, sy.x = 3.3 mg/dL.
CSF Comparison (n=40): (HiChem Results) = 0.1 mg/dL + 0.978 × (BMD Results), r = 0.999, sy.x = 1.1 mg/dL.
Predicate Device(s)
BMD Glucose/HK Reagent, product no. 704035, Sigma Glucose (HK) Reagent, procedure no. 16-UV, BMD Glucose/HK Reagent, product for. 857429
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
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SUMMARY OF 510(K) SAFETY AND EFFECTIVENESS INFORMATION
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.
HiChem Glucose/HK Reagent (product no. 70007) is for the quantitative determination of glucose in serum, plasma, cerebrospinal fluid and urine. The most common causes of abnormal glucose levels are diabetes, liver disease, and certain endocrine disorders.
The HiChem Glucose/HK Reagent determines glucose by enzymatic phosphorylation using ATP in the presence of hexokinase. The extent of this reaction, and the quantity of glucose in the specimen, is determined through the measurement of the resulting glucose-o-phosphate by producing NADH in the presence of glucose-o-phosphate dehydrogenase.
The HiChem Glucose Reagent is intended to be used either as a manual procedure or on clinical analyzers which ean automate the required manipulations. The reagent is supplied as two liquid-stable components which are combined, either before or during use, in the approximate ratio of 1 part Glucose Enzyme Reagent and 8 parts Glucose Reagent Buffer. The Glucose Enzyme Reagent can also be used as a start reagent and combined with the Reagent Buffer following sample addition.
The HiChem Glucose/HK Reagent calibrated with the HiChem Chemistry Standard, product 70023 is substantially equivalent to the BMD Glucose/HK Reagent, product no. 704035 calibrator Serum and Diluent, product no. 620213, both manufactured by Boehringer Mannheim Corp., Indianapolis, IN. and the Sigma Glucose (HK) Reagent, procedure no. 16-UV calibrated with Glucose/Urea Nitrogen Standard, product no. 16-300, both manufactured by Sigma Diagnostics, St. Louis, MO. Substantial equivalence between the HiChem and the other calibrators for the purpose of calibrating uca nitrogen methods is also shown. All three reagent/calibrator pairs support the same intended use (with the exception of the specimen limitations for the Sigma reagent) and produce equivalent results with the same clinical purpose. In addition, they are all based on the same methodology which determines glucose through the measurement of NADH production. Finally, all reagents are sold in a generic format with their use on various instruments supported through procedure supplements (application sheets).
The effectiveness of the manual procedure is shown by the recovery of linearity standards, the precision of control recoveries, a comparison of servin and plasma recoveries to the Sigma Glucose (HK) Reagent, a comparison of urine and CSF recoveries to the BMD Glucose/HK Reagent and validation of the chemical additive and reconstituted stability claims.
The recovery of glucose using HiChem Glucose/HK Reagent as a manual method is linear to at least 500 mg/dL as shown by the recovery of linearity standards which span the claimed linear range. Regression statistics are shown below.
(HiChem Results) = 2.1 mg/dL + 0.9769 x (Standard Value), r = 0.9999, Sy.x = 2.6 mg/dL.
Precision, demonstrated by replicate assay of commercially available control sera and urine pools, is shown below.
| Specimen | n | mean | within run SD | total SD |
|---|---|---|---|---|
| Low serum control | 30 | 95.6 mg/dL | 0.89 mg/dL | 2.77 mg/dL |
| High serum control | 30 | 296.1 mg/dL | 2.78 mg/dL | 4.41 mg/dL |
| Low urine pool | 30 | 18.7 mg/dL | 0.75 mg/dL | 1.50 mg/dL |
| High urine pool | 30 | 274.2 mg/dL | 2.10 mg/dL | 6.95 mg/dL |
| Low CSF control | 30 | 59.8 mg/dL | 0.78 mg/dL | 2.9 mg/dL |
| High CSF control | 30 | 41.9 mg/dL | 1.11 mg/dL | 2.8 mg/dL |
Glucose recoveries of 80 mixed serum and plasma specimens are compared between the HiChem and Sigma reagents. Glucose recoveries of 36 spiked urine specimens and 37 CSF specimens are compared between the
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- Diagnostics Division
HiChom
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HiChem Glucose/HK Reagent and the BMD Glucose/HK Reagent used on the Hitachi 704. All reagents were calibrated with their recommended calibrators. Least squares regression statistics are shown below.
| Serum/Plasma Comparison
| (HiChem Results) = 0.2 mg/dL + 1.013 x (Sigma Results) | r = 0.999, | Sy.x = 2.3 mg/dL. |
|---|---|---|
| Urine Comparison | ||
| (HiChem Results) = 4.1 mg/dL + 0.944 x (BMD Results) | r = 0.998, | Sy.x = 5.58 mg/dL. |
| CSF Comparison | ||
| (HiChem Results) = 1.9 mg/dL + 0.972 x (BMD Results) | r = 0.997, | Sy.x = 1.8 mg/dL. |
The use of heparin, EDTA, fluoride, oxalate and iodoacetate are shown to be acceptable chemical additives by comparison of spiked and unspiked serum pools. In all cases, the biases observed were less than 2 mg/dL.
The stability of the combined working reagent over 3 months at 2-8℃ and 10 days at 18-25℃ are documented through the recovery of serum controls and linearity standards which span the claimed linear range of the method. In all cases, the observed shifts in standard recovery were less than 1.8%.
The effectiveness of the automated Hitachi 704 procedure is shown by the recovery of linearity standards, the precision of control recoveries, comparison of patient specimen recoveries to the BMD Glucose/HK Reagent and the recovery of serum controls over the claimed calibration stability period.
The recovery of glucose using HiChem Glucose/HK Reagent as an automated method is linear to at least 1000 mg/dL as shown by the recovery of linearity standards which span the claimed linear range. Regression statistics are shown below.
Sy.x = 2.7 mg/dL. (HiChem Results) = 1.4 mg/dL + 0.986 × (Standard Value), r = 1.0000,
Precision, demonstrated by replicate assay of commercially available control sera and urine pools, is shown below.
| Specimen | n | mean | within run SD | total SD |
|---|---|---|---|---|
| Low serum control | 60 | 86.5 mg/dL | 0.68 mg/dL | 1.07 mg/dL |
| Mid. serum control | 60 | 294.0 mg/dL | 1.18 mg/dL | 2.09 mg/dL |
| High serum control | 60 | 577.5 mg/dL | 2.18 mg/dL | 5.39 mg/dL |
| Low urine pool | 60 | 23.5 mg/dL | 0.67 mg/dL | 0.77 mg/dL |
| High urine pool | 60 | 669.5 mg/dL | 2.41 mg/dL | 4.88 mg/dL |
| Low CSF control | 58 | 33.6 mg/dL | 1.02 mg/dL | 1.13 mg/dL |
| High CSF control | 59 | 57.2 mg/dL | 0.78 mg/dL | 1.26 mg/dL |
Glucose recoveries of 105 mixed serum and plasma specimens, 56 spiked urine specimens and 40 CSF specimens, compared between the HiChem and BMD reagents using least squares regression, yield the following statistics.
| Serum/Plasma Comparison
| (HiChem Results) = -1.1 mg/dL + 1.004 × (BMD Results) | r = 0.999, | sy.x = 1.61 mg/dL |
|---|---|---|
| Urine Comparison | ||
| (HiChem Results) = -1.4 mg/dL + 0.989 × (BMD Results) | r = 0.999, | sy.x = 3.3 mg/dL. |
| CSF Comparison | ||
| (HiChem Results) = 0.1 mg/dL + 0.978 × (BMD Results) | r = 0.999, | sy.x = 1.1 mg/dL. |
The calibration stability claim of one month is documented through the recovery of serum controls which span from 43 to 570 mg/dL glucose. In all cases, the observed shifts in recoveries over 47 days without callbration are less than the greater of 2 mg/dL or 2%.
The HiChem Glucose/HK Reagent, calibrated with the HiChem Chemistry Standard, is shown to be safe and effective and substantially equivalent to the Sigma Glucose (FK) Reagent, procedure no. 16-UV, callingted with Sigma Glucose/Urea Nitrogen Standard, product no. 16-300 and the BMD Glucose/HK Reagent, product for. 857429, calibrated with Precical Calibrator Serum and Diluent, product no. 620213.
Wynne Stacking
Wynn Stocking Regulatory Affairs Manager