(285 days)
Not Found
No
The device description and performance studies focus on the chemical reaction and optical measurement of glucose concentration, with no mention of AI or ML.
No
The device is described as "For in vitro diagnostic use only" and measures glucose concentration to aid in the "diagnosis and treatment" of certain conditions. It does not exert a therapeutic effect on the patient.
Yes.
The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only" and explains that the glucose measurements are "used in the diagnosis and treatment of carbohydrate metabolism disorders."
No
The device description clearly describes a physical, multilayered analytical element (a slide) that undergoes a chemical reaction and is measured by reflected light. This is a hardware component, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For in vitro diagnostic use only."
- Sample Type: The device is used to measure glucose in biological samples (serum, plasma, urine, and cerebrospinal fluid) which are collected from the human body but tested outside of the body. This is the definition of in vitro.
- Diagnostic Purpose: The glucose measurements are used "in the diagnosis and treatment of carbohydrate metabolism disorders," which is a diagnostic application.
N/A
Intended Use / Indications for Use
For in vitro diagnostic use only. VITROS Chemistry Products GLU Slides are used on VITROS Systems to quantitatively measure glucose (GLU) concentration in serum, plasma, urine and cerebrospinal fluid.
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.
Product codes (comma separated list FDA assigned to the subject device)
CGA
Device Description
The VITROS GLU Slide is a multilayered, analytical element coated on a polyester support. A drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. The oxidation of sample glucose is catalyzed by glucose oxidase to form hydrogen peroxide and gluconate. This reaction is followed by an oxidative coupling catalyzed by peroxidase in the presence of dye precursors to produce a dye. The intensity of the dye is measured by reflected light.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
For in vitro diagnostic use only.
Prescription Use (Part 21 CFR 801 Subpart D)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method comparison Predicate vs Feature: Human serum, urine and CSF samples were tested with the modified VITROS Chemistry Products GLU Slides (feature) and compared to the current VITROS Chemistry Products GLU Slides (predicate). Results followed CLSI Protocol EP09-A3.
Sample sizes: Serum (113 observations), Urine (105 observations), CSF (165 observations).
Correlation: Serum (1.000), Urine (0.999), CSF (1.000).
Key results: Linear correlation found between modified and predicate devices for all sample types.
Precision: Long term precision testing followed CLSI Protocol EP05-A3, using the modified VITROS Chemistry Products GLU Slides on the VITROS Systems. The test included a minimum of 80 observations (2 replicates per run, 2 runs per day over 20 days) for serum, urine and CSF specimens.
For Serum: Mean Conc. (mg/dL) - 29.4 (Pool 1), 90.3 (PV I), 287.2 (PV II), 571.2 (Pool 2). Within lab CV% - 1.3, 1.6, 1.2, 0.9 respectively.
For Urine: Mean Conc. (mg/dL) - 31.6 (Control 1), 301.4 (Control 2), 574.5 (Pool 1). Within lab CV% - 1.5, 1.5, 1.0 respectively.
For CSF: Mean Conc. (mg/dL) - 37.2 (Pool 1), 49.2 (Liquid PV I), 88.9 (Liquid PV II), 283.0 (Pool 2), 609.3 (Pool 3). Within lab CV% - 1.5, 1.3, 1.2, 1.3, 0.7 respectively.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics reported are:
Correlation: Serum (1.000), Urine (0.999), CSF (1.000)
Slope: Serum (1.01), Urine (1.03), CSF (1.04)
y-intercept: Serum (-0.80), Urine (-0.81), CSF (-2.74)
Precision (Within Lab CV%):
Serum: 1.3%, 1.6%, 1.2%, 0.9%
Urine: 1.5%, 1.5%, 1.0%
CSF: 1.5%, 1.3%, 1.2%, 1.3%, 0.7%
Limit of Blank (LOB): Serum 1 mg/dL, Urine 7 mg/dL, CSF 4 mg/dL
Limit of Detection (LOD): Serum 2 mg/dL, Urine 8 mg/dL, CSF 5 mg/dL
Limit of Quantitation (LOQ): Serum 9 mg/dL, Urine 18 mg/dL, CSF 20 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.
Not Found
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).
Not Found
§ 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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 18. 2017
ORTHO CLINICAL DIAGNOSTICS DARLENE PHILLIPS MANAGER REGULATORY AFFAIRS 100 INDIGO CREEK DRIVE ROCHESTER NY 14626
Re: K163433
Trade/Device Name: VITROS Chemistry Products GLU Slides Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: CGA Dated: August 15, 2017 Received: August 16, 2017
Dear Darlene Phillips:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kellie B. Kelm -S
for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K163433
Device Name VITROS Chemistry Products GLU Slides
Indications for Use (Describe)
For in vitro diagnostic use only. VITROS Chemistry Products GLU Slides are used on VITROS Systems to quantitatively measure glucose (GLU) concentration in serum, plasma, urine and cerebrospinal fluid.
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.
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
1. 510(k) Summary
Submitter Information
| Name | Ortho-Clinical Diagnostics, Inc. |
|---|---|
| Address | 100 Indigo Creek Drive |
| Rochester, New York 14626 | |
| Phone number | (585) 453-4253 |
| Fax number | (585) 453-3368 |
| Establishment | |
| Registration | |
| Number | 1319809 |
| Name of | |
| contact person | Darlene J Phillips |
| Date prepared | September 18, 2017 |
| Name of devices | |
| Trade or proprietary names | VITROS Chemistry Products GLU Slides |
| Common or usual name | VITROS GLU Slides assay |
| Common or usual name | Glucose oxidase, glucose |
| Classification name | Glucose test system |
| Classification panel | Clinical Chemistry |
| Regulation | 21 CFR 862.1345 |
| Product Code | CGA |
Legally marketed device(s) to which equivalence is claimed
The VITROS® Chemistry Products GLU Slides (modified) are substantially equivalent to the VITROS® Chemistry Products GLU Slides (current). The FDA cleared the VITROS® Chemistry Products GLU Slides on May 17, 1996 (K955286).
Reason for 510(k) submission
The device modification is a proportional reduction in the amount of reagent used to manufacture each VITROS GLU Slide (or test). Each modified VITROS GLU Slide will have approximately 30% less ingredients compared to the current VITROS GLU Slide as a result of a smaller surface area. Since the reduction in ingredients per slide is due to a smaller surface area, the proportional concentration of ingredients of the modified VITROS GLU slide will be unchanged compared to the current VITROS GLU Slide. This device modification reduces the sample volume required per test from 10 µL per test to 6 µL per test.
Device description
The VITROS GLU Slide is a multilayered, analytical element coated on a polyester support. A drop of patient sample is deposited on the slide and is evenly distributed
4
by the spreading layer to the underlying layers. The oxidation of sample glucose is catalyzed by glucose oxidase to form hydrogen peroxide and gluconate. This reaction is followed by an oxidative coupling catalyzed by peroxidase in the presence of dye precursors to produce a dye. The intensity of the dye is measured by reflected light.
Intended Use/ Indications for Use
For in vitro diagnostic use only. VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid using VITROS Systems. 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 Conditions for Use Statement: For prescription use only.
Comparison with Predicate Devices:
| predicate device | ||
|---|---|---|
| Device | ||
| Characteristic | New Device | |
| VITROS GLU Slide | ||
| (Modified) | Predicate Device | |
| VITROS GLU Slide[K955286] | ||
| (Current) | ||
| Intended Use | No Change. | For in vitro diagnostic use only. |
| VITROS® Chemistry Products GLU | ||
| Slides quantitatively measure | ||
| glucose (GLU) concentration in | ||
| serum, plasma, urine, and | ||
| cerebrospinal fluid. | ||
| Sample volume | $6 \mu L$ | $10 \mu L$ |
| Concentrations | ||
| of Slide | ||
| Reactive | ||
| Ingredients per | ||
| cm-squared | No Change | Glucose oxidase (Aspergillus sp.) |
| $0.77$ U; peroxidase (horseradish root) | ||
| $3.6$ U; 1,7- dihydroxynaphthalene | ||
| (dye precursor) $67 \mu g$ and 4- | ||
| aminoantipyrine hydrochloride (dye | ||
| precursor) $0.11$ mg. | ||
| Amount of Slide | ||
| Reactive | ||
| Ingredients per | ||
| Slide (test) | Glucose oxidase | |
| (Aspergillus sp.) $0.77$ U; | ||
| peroxidase (horseradish root) | ||
| $3.6$ U; 1,7- | ||
| dihydroxynaphthalene (dye | ||
| precursor) $67 \mu g$ and 4- | ||
| aminoantipyrine | ||
| hydrochloride (dye | ||
| precursor) $0.11$ mg. | Glucose oxidase (Aspergillus sp.) | |
| $0.99$ U; peroxidase (horseradish root) | ||
| $4.7$ U; 1,7- dihydroxynaphthalene | ||
| (dye precursor) $86 \mu g$ and 4- | ||
| aminoantipyrine hydrochloride (dye | ||
| precursor) $0.14$ mg. |
Summary of the technological characteristics of the device compared to the nredicate device
5
| Device
Characteristic | New Device
VITROS GLU Slide
(Modified) | Predicate Device
VITROS GLU Slide[K955286]
(Current) |
|------------------------------------|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Description | No Change | The VITROS GLU assay is
performed using the VITROS
Chemistry Products GLU Slides and
the VITROS Chemistry Products
Calibrator Kit 1 on the VITROS
Systems. The VITROS GLU Slide is
a multi-layered, analytical element
coated on a polyester support. The
method is based on an enzymatic
detection. All reactions necessary for
a single quantitative measurement of
glucose take place within the multi-
layered analytical element of a
VITROS GLU Slide. A drop of
sample fluid is metered onto the slide
and a reaction occurs which
ultimately results in the oxidation of
dye precursors by peroxidase. The
concentration of glucose in the
sample is determined by measuring
the intensity of the dye using
reflectance spectrophotometry. |
| Basic Principle | No Change | Enzymatic Endpoint test using
reflectance spectrophotometry. |
| Sample type | No Change | Serum, plasma, urine, and
cerebrospinal fluid |
| Assay Range | No Change | Serum: 20.0-625.0 mg/dL
Urine and CSF: 20.0-650.0 mg/dL |
| Incubation time
and temperature | No Change | 5 minutes at 37°C |
Summary of the technological characteristics of the device compared to the predicate device
6
Non-Clinical Testing Analytical Performance:
Method comparison Predicate vs Feature
To demonstrate substantial equivalence with the predicate, human serum, urine and CSF samples were tested with the modified VITROS Chemistry Products GLU Slides (feature) and the results obtained were compared to those obtained using the current VITROS Chemistry Products GLU Slides (predicate). Method Comparison testing followed CLSI Protocol EP09-A3, Measurement Procedure Comparison and Bias Estimation Using Patient Samples. The correlation between the predicate and the modified VITROS GLU Slides on the VITROS 4600 Chemistry System is summarized below.
| No. Obs. | Slope | y-intercept | Correlation | |
|---|---|---|---|---|
| Serum | 113 | 1.01 | -0.80 | 1.000 |
| Urine | 105 | 1.03 | -0.81 | 0.999 |
| CSF | 165 | 1.04 | -2.74 | 1.000 |
Units (mg/dL)
Precision
Long term precision testing followed CLSI Protocol EP05-A3, Evaluation of Precision Performance of Quantitative Methods; Approved Guideline—Third Edition, using the modified VITROS Chemistry Products GLU Slides on the VITROS Systems. The test included a minimum of 80 observations (2 replicates per run, 2 runs per day over 20 days) for serum, urine and CSF specimens. The long term precision of the modified VITROS GLU Slides on the VITROS 4600 Chemistry System is summarized below.
Precision
| Serum | Mean
Conc. | Within
day SD* | Within lab
SD** | Within Lab
CV% | No.
Obs. | No. Days |
|--------------|---------------|-------------------|--------------------|-------------------|-------------|----------|
| Serum Pool 1 | 29.4 | 0.24 | 0.39 | 1.3 | 88 | 22 |
| PV I | 90.3 | 0.63 | 1.47 | 1.6 | 88 | 22 |
| PV II | 287.2 | 1.56 | 3.35 | 1.2 | 88 | 22 |
| Serum Pool 2 | 571.2 | 3.28 | 4.99 | 0.9 | 88 | 22 |
Units (mg/dL)
| Urine | Mean
Conc. | Within
day SD* | Within lab
SD** | Within Lab
CV% | No.
Obs. | No.
Days |
|--------------|---------------|-------------------|--------------------|-------------------|-------------|-------------|
| Control 1 | 31.6 | 0.34 | 0.47 | 1.5 | 88 | 22 |
| Control 2 | 301.4 | 2.84 | 4.48 | 1.5 | 88 | 22 |
| Urine Pool 1 | 574.5 | 4.05 | 5.46 | 1.0 | 88 | 22 |
Units (mg/dL)
7
| CSF | Mean
Conc. | Within
day SD* | Within lab
SD** | Within Lab
CV% | No.
Obs. | No.
Days |
|--------------|---------------|-------------------|--------------------|-------------------|-------------|-------------|
| CSF Pool 1 | 37.2 | 0.29 | 0.56 | 1.5 | 88 | 22 |
| Liquid PV I | 49.2 | 0.45 | 0.64 | 1.3 | 88 | 22 |
| Liquid PV II | 88.9 | 0.58 | 1.11 | 1.2 | 88 | 22 |
| CSF Pool 2 | 283.0 | 1.69 | 3.55 | 1.3 | 88 | 22 |
| CSF Pool 3 | 609.3 | 2.58 | 4.03 | 0.7 | 88 | 22 |
Units (mg/dL)
- Within Day precision was determined using two runs per day with two replications.
** Within Lab precision was determined using a single lot of slides and calibrating weekly.
Limit of Blank, Detection and Quantitation (LoB/LoD/LoQ)
The Limit of Blank (LOB), Limit of Detection (LOD), and Limit of Quantitation (LOO) of the VITROS GLU assay were determined according to CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures. The following limits of the modified VITROS GLU Slides assay are summarized below:
Limit of Blank, Detection and Quantitation Calculated
| Fluid Type | LOB (mg/dL) | LOD (mg/dL) | LOQ (mg/dL) |
|---|---|---|---|
| Serum | 1 | 2 | 9 |
| Urine | 7 | 8 | 18 |
| CSF | 4 | 5 | 20 |
The Limit of Quantitation is defined as the lowest amount of analyte in the sample that can be quantitatively determined with stated acceptable precision and trueness, under stated experimental conditions. A properly operating VITROS System should exhibit a LoQ value of 20 mg/dL with serum, plasma, urine and CSF specimens.
Linearity
Linearity was determined following CLSI EP06-A: Evaluation of the Linearity of Quantitative Measurement Procedures: a Statistical Approach: Approved Guideline. A high GLU pool was intermixed with a low pool to generate 14 concentration levels each tested in six replicate determinations for each body fluid type, serum, urine and CSF. Linear results were compared to 2nd and 3rd order polynomial fits against a pre-specified allowable error. Analysis by linear regression indicated that the assay is linear across the measuring range of each fluid type.
8
Matrix Comparison
The performance of plasma specimens were compared to serum using a paired serum/plasma blood draw.
The results indicated that serum (stored removed from the clot), EDTA, both sodium and lithium heparin, and sodium fluoride/potassium oxalate plasma are suitable for use with the VITROS Chemistry Products GLU Slides assay.
Measuring Range and Expected Values
The modification does not impact the measuring range and expected values of the modified VITROS GLU Slides assays. Current claims will apply as summarized below. Each laboratory should confirm the validity of these intervals for the population it serves.
Measuring (Reportable or Dynamic) Range
| Serum | 20.0 – 625.0 mg/dL |
|---|---|
| Urine | 20.0 – 650.0 mg/dL |
| CSF | 20.0 – 650.0 mg/dL |
Expected Values
| Serum | |
|---|---|
| Fasting Adults | 74 - 106 mg/dL |
| Urine | |
| Random |