(285 days)
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.
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.
The document describes the non-clinical testing and performance of the VITROS Chemistry Products GLU Slides (modified) to demonstrate its substantial equivalence to the legally marketed predicate device, the VITROS Chemistry Products GLU Slides (current).
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a table format with specific thresholds. Instead, it presents results from various analytical performance studies, implying that the obtained performance (e.g., correlation coefficients, precision values, LOB/LOD/LOQ) met the internal criteria for demonstrating equivalence to the predicate device. For the purpose of this response, I will list the reported performance values from the "Non-Clinical Testing Analytical Performance" section, as these are the data used to prove the device meets the underlying requirements for equivalence.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance (Modified VITROS GLU Slides) |
|---|---|---|
| Method Comparison (vs. Predicate) | Strong correlation to predicate (slope near 1, intercept near 0, high R) | |
| Serum (N=113) slope | N/A (implied close to 1) | 1.01 |
| Serum (N=113) y-intercept | N/A (implied close to 0) | -0.80 mg/dL |
| Serum (N=113) Correlation | N/A (implied close to 1) | 1.000 |
| Urine (N=105) slope | N/A (implied close to 1) | 1.03 |
| Urine (N=105) y-intercept | N/A (implied close to 0) | -0.81 mg/dL |
| Urine (N=105) Correlation | N/A (implied close to 1) | 0.999 |
| CSF (N=165) slope | N/A (implied close to 1) | 1.04 |
| CSF (N=165) y-intercept | N/A (implied close to 0) | -2.74 mg/dL |
| CSF (N=165) Correlation | N/A (implied close to 1) | 1.000 |
| Precision (Within Lab CV%) | N/A (implied low CV% for different concentrations) | |
| Serum (29.4 mg/dL) | N/A | 1.3 % |
| Serum (90.3 mg/dL) | N/A | 1.6 % |
| Serum (287.2 mg/dL) | N/A | 1.2 % |
| Serum (571.2 mg/dL) | N/A | 0.9 % |
| Urine (31.6 mg/dL) | N/A | 1.5 % |
| Urine (301.4 mg/dL) | N/A | 1.5 % |
| Urine (574.5 mg/dL) | N/A | 1.0 % |
| CSF (37.2 mg/dL) | N/A | 1.5 % |
| CSF (49.2 mg/dL) | N/A | 1.3 % |
| CSF (88.9 mg/dL) | N/A | 1.2 % |
| CSF (283.0 mg/dL) | N/A | 1.3 % |
| CSF (609.3 mg/dL) | N/A | 0.7 % |
| Limit of Quantitation (LoQ) | 20 mg/dL for all fluid types (specified for a properly operating system) | |
| Serum LoQ | 20 mg/dL | 9 mg/dL |
| Urine LoQ | 20 mg/dL | 18 mg/dL |
| CSF LoQ | 20 mg/dL | 20 mg/dL |
| Linearity | Linear across the measuring range for each fluid type | Linear across the measuring range of each fluid type |
| Matrix Comparison (Plasma vs. Serum) | Serum, EDTA, sodium and lithium heparin, and sodium fluoride/potassium oxalate plasma deemed suitable. | Suitable for use |
| Interfering Substances | Substances exhibiting bias less than stated acceptance criteria are cited as non-interfering. | Various substances identified with or without interference. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Sizes for Test Set (Method Comparison):
- Serum: 113 observations
- Urine: 105 observations
- CSF: 165 observations
- Sample Sizes for Test Set (Precision):
- Minimum of 80 observations (2 replicates per run, 2 runs per day over 20 days) for serum, urine, and CSF specimens. The tables show 88 observations over 22 days for each pool/control.
- Sample Sizes for Test Set (LoB/LoD/LoQ) and Linearity: Not explicitly stated as distinct sample sizes, but implied to be sufficient for CLSI protocols. For linearity, 14 concentration levels with six replicate determinations for each body fluid type.
- Data Provenance: The document does not specify the country of origin of the data. It indicates these were human samples for method comparison ("human serum, urine and CSF samples") and various pools/controls for precision testing. It implies these were collected prospectively for the purpose of the study to compare the modified device against the current predicate by following CLSI protocols.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This section is not applicable to this document. The device is an in vitro diagnostic (IVD) chemistry product that quantitatively measures glucose concentration. The "ground truth" for its performance studies is established by quantitative comparisons to a predicate device (e.g., method comparison), statistical analysis of precision, and adherence to established analytical performance guidelines (CLSI protocols), not by expert consensus or interpretation of images.
4. Adjudication Method for the Test Set
This is not applicable for this type of IVD device. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation (e.g., radiology studies) where disagreement among reviewers needs resolution to establish a consensus ground truth. This document describes analytical performance studies of a quantitative measurement device.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. This document describes an IVD device for quantitative glucose measurement, not an AI-assisted diagnostic tool that involves human readers or interpretation of cases.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
This is not applicable in the context of "algorithm only." The device itself is an automated chemical analyzer component (slides) for measuring glucose. The performance studies describe the standalone analytical performance of the device (modified VITROS GLU Slides) when used on VITROS Systems, primarily compared to the predicate device and assessed for its inherent analytical characteristics (precision, linearity, limits). There is no "human-in-the-loop" component in the direct measurement process itself beyond loading samples and running the system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in these studies is primarily established by:
- Comparison to a Legally Marketed Predicate Device: For method comparison, the results generated by the predicate VITROS Chemistry Products GLU Slides (current) are used as the reference "truth" to assess the modified device's equivalence.
- CLSI Protocol Standards: For precision, linearity, and detection limits, the "ground truth" is defined by adherence to CLSI (Clinical and Laboratory Standards Institute) protocols and the statistical methodologies they outline for establishing these performance characteristics. This involves statistical calculations and comparisons to pre-defined statistical acceptance criteria (even if not explicitly listed in the table, they are inherent in CLSI guidelines).
8. The Sample Size for the Training Set
This is not applicable. The document describes the analytical performance studies of a modified IVD assay. There is no mention of machine learning or AI components that would require a "training set" in the conventional sense. The "training" of the device is through its manufacturing and calibration, not through a data-driven model.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no "training set" in the context of this device's development as described.
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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.
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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
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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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1. 510(k) Summary
Submitter Information
| Name | Ortho-Clinical Diagnostics, Inc. |
|---|---|
| Address | 100 Indigo Creek DriveRochester, New York 14626 |
| Phone number | (585) 453-4253 |
| Fax number | (585) 453-3368 |
| EstablishmentRegistrationNumber | 1319809 |
| Name ofcontact 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
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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 | ||
|---|---|---|
| DeviceCharacteristic | New DeviceVITROS GLU Slide(Modified) | Predicate DeviceVITROS GLU Slide[K955286](Current) |
| Intended Use | No Change. | For in vitro diagnostic use only.VITROS® Chemistry Products GLUSlides quantitatively measureglucose (GLU) concentration inserum, plasma, urine, andcerebrospinal fluid. |
| Sample volume | $6 \mu L$ | $10 \mu L$ |
| Concentrationsof SlideReactiveIngredients percm-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 (dyeprecursor) $0.11$ mg. |
| Amount of SlideReactiveIngredients perSlide (test) | Glucose oxidase(Aspergillus sp.) $0.77$ U;peroxidase (horseradish root)$3.6$ U; 1,7-dihydroxynaphthalene (dyeprecursor) $67 \mu g$ and 4-aminoantipyrinehydrochloride (dyeprecursor) $0.11$ 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 (dyeprecursor) $0.14$ mg. |
Summary of the technological characteristics of the device compared to the nredicate device
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| DeviceCharacteristic | New DeviceVITROS GLU Slide(Modified) | Predicate DeviceVITROS GLU Slide[K955286](Current) |
|---|---|---|
| DeviceDescription | No Change | The VITROS GLU assay isperformed using the VITROSChemistry Products GLU Slides andthe VITROS Chemistry ProductsCalibrator Kit 1 on the VITROSSystems. The VITROS GLU Slide isa multi-layered, analytical elementcoated on a polyester support. Themethod is based on an enzymaticdetection. All reactions necessary fora single quantitative measurement ofglucose take place within the multi-layered analytical element of aVITROS GLU Slide. A drop ofsample fluid is metered onto the slideand a reaction occurs whichultimately results in the oxidation ofdye precursors by peroxidase. Theconcentration of glucose in thesample is determined by measuringthe intensity of the dye usingreflectance spectrophotometry. |
| Basic Principle | No Change | Enzymatic Endpoint test usingreflectance spectrophotometry. |
| Sample type | No Change | Serum, plasma, urine, andcerebrospinal fluid |
| Assay Range | No Change | Serum: 20.0-625.0 mg/dLUrine and CSF: 20.0-650.0 mg/dL |
| Incubation timeand temperature | No Change | 5 minutes at 37°C |
Summary of the technological characteristics of the device compared to the predicate device
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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 | MeanConc. | Withinday SD* | Within labSD** | Within LabCV% | 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 | MeanConc. | Withinday SD* | Within labSD** | Within LabCV% | 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)
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| CSF | MeanConc. | Withinday SD* | Within labSD** | Within LabCV% | 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.
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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 | < 30 mg/dL |
| 24-hour | < 500 mg/day* |
| CSF | 40 - 70 mg/dL |
*Glucose concentration (md/dL) x 24-hour volume (dL) = mg/day
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Interfering Substances
Specimens Not Recommended
Urine with the following preservatives:
- . Acetic acid
- . Hydrochloric acid
The VITROS Chemistry Products GLU Slide assay was screened for interfering substances following CLSI Protocol EP07-A2, Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition.
The presence of N-Acetylcysteine, cholesterol, glutathione, dextran and total protein in serum are known to cause bias in assay results.
High levels of ascorbic acid in urine will cause a large negative bias, potentially resulting in values less than the measuring range. The degree of bias is proportional to the ascorbic acid concentration.
The presence of hemoglobin in CSF is known to cause a positive bias in assay results.
Substances exhibiting bias less than the stated acceptance criteria have been cited as substances that do not interfere. It is possible that other interfering substances may be encountered. These results are representative; however results may differ somewhat due to test-to-test variation. The degree of interference at concentrations other than those listed may not be predictable.
Conclusion:
The conclusions drawn from the nonclinical tests (discussed above) demonstrate the modified VITROS Chemistry Products GLU Slides assay is as safe, effective, and perform as well as the predicate device, current VITROS Chemistry Products GLU Slides assay. The information submitted in the premarket notification is complete and supports a substantial equivalence decision.
§ 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.