(101 days)
In vitro test for the quantitative determination of glucose in serum, plasma, urine and cerebrospinal fluid (CSF).
Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia and pancreatic islet cell tumors.
The cassette COBAS INTEGRA Glucose HK Gen. 3 contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA SYSTEMS for the quantitative determination of glucose in serum, plasma, urine, and cerebrospinal fluid (CSF).
The test principle is an enzymatic reference method with hexokinase.
The provided text describes the COBAS INTEGRA Glucose HK Gen. 3 Assay but does not explicitly state acceptance criteria in a pass/fail format. Instead, it presents performance characteristics (precision, linearity, analytical sensitivity, interference, method comparison) and compares them to a predicate device to establish substantial equivalence.
Based on the provided information, here's a structured response:
1. Table of Acceptance Criteria and Reported Device Performance
As explicit acceptance criteria are not stated for the device per se, the table below compares the performance of the COBAS INTEGRA Glucose HK Gen. 3 Assay to its predicate device, COBAS INTEGRA Glucose HK Gen. 3 (K061048), which served as the benchmark for substantial equivalence. The implication is that the new device must perform comparably to or better than the predicate.
| Feature / Performance Metric | Predicate Device (K061048) Performance | COBAS INTEGRA Glucose HK Gen. 3 Assay Performance | Implicit Acceptance Standard (vs. Predicate) | Meets Std? |
|---|---|---|---|---|
| Measuring Range (Regular Applications) | 2.16 - 720 mg/dL | 4.32 - 720 mg/dL | Should be comparable or improved. The lower limit is slightly higher for the new device. | Yes* |
| Measuring Range (Stat Applications) | Not specified (only Regular) | 4.32 - 541 mg/dL | New feature, performance is reported. | NA |
| Precision - Serum (Regular Application) | ||||
| Repeatability (Within-Run CV%) | Level I: 0.41%, Level II: 0.47% | HS1: 0.69%, HS2: 0.78%, HS3: 0.70%, PNU: 0.58%, PPU: 0.59% | Comparable CV% values. | Yes |
| Intermediate (Between Run CV%) | Level I: 1.09%, Level II: 0.90% | HS1: 1.26%, HS2: 1.41%, HS3: 1.32%, PNU: 1.24%, PPU: 1.21% | Comparable or slightly higher CV%. | Yes |
| Precision - Serum (Stat Application) | Not specified | Repeatability: 0.57-0.74%, Intermediate: 1.07-1.40% | New feature, performance is reported. | NA |
| Precision - Urine (Regular Application) | ||||
| Repeatability (Within-Run CV%) | Level I: 1.35%, Level II: 0.64% | HS1: 2.28%, HS2: 1.05%, HS3: 0.53%, PNU: 0.58%, PPU: 0.59% | Comparable CV% values. | Yes |
| Intermediate (Between Run CV%) | Level I: 0.75%, Level II: 0.83% | HS1: 2.83%, HS2: 1.37%, HS3: 1.01%, PNU: 1.24%, PPU: 1.21% | Comparable or slightly higher CV%. | Yes |
| Precision - Urine (Stat Application) | Not specified | Repeatability: 0.57-2.71%, Intermediate: 1.07-3.20% | New feature, performance is reported. | NA |
| Precision - CSF (Regular Application) | ||||
| Repeatability (Within-Run CV%) | Level I: 1.13%, Level II: 1.49% | Level I: 1.13%, Level II: 1.49% | Identical CV% values. | Yes |
| Precision - CSF (Stat Application) | Not specified | Repeatability: 0.39-0.63% | New feature, performance is reported. | NA |
| Analytical Sensitivity (Lower Limits) | Lower Detection Limit: 2.16 mg/dL | Limit of Blank: 2.16 mg/dL, Limit of Detection: 4.32 mg/dL | Comparable. Limit of detection is slightly higher for the new device. | Yes* |
| Method Comparison - Serum (new vs. Stat application) | Not applicable (no Stat application in predicate) | Passing Bablok: y=0.997x + 0.033 mmol/L, $\tau = 0.999$, SD (md 95) = 0.067 | High correlation between regular and Stat application. | NA |
| Method Comparison - Urine (new vs. Stat application) | Not applicable (no Stat application in predicate) | Passing Bablok: y=1.00x + 0.002 mmol/L, $\tau = 0.996$, SD (md 95) = 0.082 | High correlation between regular and Stat application. | NA |
Note on "Yes": While the lower measuring range and detection limits for the new device are slightly different (higher lower limit for measuring range, higher limit of detection), these values are still within clinically acceptable ranges for glucose measurements and are explicitly stated, indicating the device meets its own defined performance specifications, and the differences are not deemed substantial enough to prevent equivalence. The 510(k) cleared the device, implying these differences were acceptable.
2. Sample sizes used for the test set and data provenance
- Precision Studies (Serum, Urine, CSF): The tables provide "Sample" categories (e.g., HS1, HS2, HS3, PNU, PPU, Level I, Level II) with their Mean (mg/dL) and CV (%). The exact number of individual samples within each of these categories tested for precision is not explicitly stated. However, precision studies in IVD usually involve replicate measurements (e.g., 20 replicates over multiple days) of a few representative samples at different concentration levels.
- Method Comparison - Serum: n=79 human serum samples
- Method Comparison - Urine: n=50 human urine samples
- Data Provenance: Not explicitly stated (e.g., country of origin). Given the manufacturer is Roche Diagnostics (Indianapolis, IN, USA), it is likely the studies involved samples sourced within the US or under similar regulatory guidelines. The data is prospective in the sense that it was collected specifically for the purpose of demonstrating the device's performance characteristics for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and their qualifications
This device is an in vitro diagnostic (IVD) assay for quantitative determination of glucose. For such devices, "ground truth" is typically established by comparing the device's results to a reference method or an established, legally marketed predicate device, as seen in the "Method Comparison" section. This does not involve human expert adjudication in the same way as, for example, image interpretation. Performance is assessed by comparing quantitative results against an accepted standard.
4. Adjudication method for the test set
Not applicable for this type of quantitative IVD assay. Performance is assessed through statistical comparison to a predicate device or reference method, and by demonstrating performance characteristics (precision, linearity, analytical sensitivity) meet established analytical requirements.
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
Not applicable. This is an automated in vitro diagnostic assay, not an AI-assisted diagnostic tool that involves human readers interpreting cases.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the studies reported are assessing the standalone performance of the assay (reagent system and instrument). The measurements are quantitative chemical analyses performed by the COBAS INTEGRA system using the Glucose HK Gen. 3 reagent, without human interpretation influencing the numerical result.
7. The type of ground truth used
For this IVD device, the "ground truth" for evaluating its performance (beyond foundational analytical studies):
- Precision: Internal consistency of the device's own measurements.
- Method Comparison: Comparison against the same reagent (COBAS INTEGRA Glucose HK Gen. 3) on the same analyzer (COBAS INTEGRA 800) but using the Stat application instead of Regular, to demonstrate concordance between the different applications of the device. This implies the regular application (and the predicate device it supersedes) serves as a de facto reference. The initial predicate device would have been validated against a more universally accepted glucose reference method.
8. The sample size for the training set
Not applicable in the context of an IVD assay like this. There is no machine learning "training set" for an enzymatic assay. The "training" in this context refers to the development and optimization of the reagent formulation and instrument parameters. The studies presented are performance validation studies.
9. How the ground truth for the training set was established
Not applicable for this type of device. The "ground truth" (i.e., true glucose concentration) for developing and validating an assay relies on well-characterized samples and reference methods. The provided document focuses on the validation of the device against an existing predicate/application.
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Glucose HK Gen. 3 Stat Assay
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| 510(k) Summary | 1092603 |
|---|---|
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence. |
| Submittername, address,contact | Roche Diagnostics9115 Hague RoadIndianapolis, IN 46250(317) 521 - 3831 |
| Contact Person: Kathie J. Goodwin | |
| Date Prepared: August 24th, 2009 | |
| Device Name | Proprietary names: COBAS INTEGRA Glucose HK Gen. 3 Assay |
| Common names: Glucose HK Gen. 3 | |
| Classification names: Glucose Test System | |
| Regulation Number: 21 CFR 862.1345 | |
| Product codes: CFR | |
| DeviceDescription | The cassette COBAS INTEGRA Glucose HK Gen. 3 contains an invitro diagnostic reagent system intended for use on COBASINTEGRA SYSTEMS for the quantitative determination of glucose inserum, plasma, urine, and cerebrospinal fluid (CSF). |
| The test principle is an enzymatic reference method with hexokinase. | |
| Intended use | In vitro test for the quantitative determination of glucose in serum, plasma,urine and cerebrospinal fluid (CSF). |
| Indications forUse | Glucose measurements are used in the diagnosis and treatment ofcarbohydrate metabolism disorders including diabetes mellitus, neonatalhypoglycemia, idiopathic hypoglycemia and pancreatic islet cell tumors. |
:
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Substantial equivalence The table below indicates the similarities between the modified COBAS INTEGRA Glucose HK Gen. 3 test and its predicate device COBAS INTEGRA Glucose HK Gen. 3, K061048.
Substantial equivalence -
comparison
| Feature | COBAS INTEGRA Glucose Gen. 3AssaySerum/Plasma Application | Predicate Device: COBASINTEGRA Glucose Gen. 3 AssaySerum/Plasma Application(K061048) |
|---|---|---|
| Intended Use | In vitro test for the quantitativedetermination of glucose in serum,plasma, urine, and cerebrospinal fluid(CSF) on COBAS INTEGRAsystems. | Same |
| Assay Protocol | Enzymatic reference method withHexokinase | Same |
| Sample Type | SerumPlasma: Li-heparin, K2-EDTA, K3-EDTA and fluoride plasma | Same |
| Calibrator | Calibrator f.a.s. | Same |
| CalibrationFrequency | Each lot and as required followingquality control procedures | Same |
| Controls | Precinorm U or Precinorm U PlusAndPrecipath U or Precipath U Plus | Same |
| Reagent Stability | Shelf life at 2 to 8°CIntegra 400/400 Plus: On-board in useat 10-15°C for 8 weeksIntegra 800: On-board in use at 8°Cfor 8 weeks | Same |
| MeasuringRange | Regular Applications:4.32 - 720 mg/dLStat Applications:4.32 - 541 mg/dL | Regular Applications:2.16 - 720 mg/dL |
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Substantial equivalence –
comparison
1/1
| comparisonFeature | COBAS INTEGRA Glucose Gen. 3 AssaySerum/Plasma Application | Predicate Device: COBAS INTEGRA Glucose Gen. 3 AssaySerum/Plasma Application (K061048) | ||||
|---|---|---|---|---|---|---|
| Precision - Serum/Plasma | Serum – Regular Application:Repeatability (Within-Run Precision) | Serum:Within-Run Precision | ||||
| Sample | Mean (mg/dL) | CV (%) | Sample | Mean (mg/dL) | CV (%) | |
| HS1 | 64.3 | 0.69 | Level I | 80.7 | 0.41 | |
| HS2 | 120 | 0.78 | Level II | 225 | 0.47 | |
| HS3 | 665 | 0.70 | ||||
| PNU | 90.8 | 0.58 | ||||
| PPU | 247 | 0.59 | ||||
| Intermediate (Between Run Precision) | Between Run | |||||
| Sample | Mean (mg/dL) | CV (%) | Sample | Mean (mg/dL) | CV (%) | |
| HS1 | 64.3 | 1.26 | Level I | 80.0 | 1.09 | |
| HS2 | 120 | 1.41 | Level II | 225 | 0.90 | |
| HS3 | 665 | 1.32 | ||||
| PNU | 90.8 | 1.24 | ||||
| PPU | 247 | 1.21 | ||||
| Serum - Stat Application:Repeatability (Within-Run Precision) | ||||||
| Sample | Mean (mg/dL) | CV (%) | ||||
| HS1 | 64.7 | 0.61 | ||||
| HS2 | 121 | 0.69 | ||||
| HS3 | 487 | 0.74 | ||||
| PNU | 91.4 | 0.58 | ||||
| PPU | 249 | 0.57 | ||||
| Intermediate (Between Run Precision) | ||||||
| Sample | Mean (mg/dL) | CV (%) | ||||
| HS1 | 64.7 | 1.08 | ||||
| HS2 | 121 | 1.40 | ||||
| HS3 | 487 | 1.10 | ||||
| PNU | 91.4 | 1.15 | ||||
| PPU | 249 | 1.07 |
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Substantial equivalence –
| Feature | COBAS INTEGRA Glucose Gen. 3 AssaySerum/Plasma Application | Predicate Device: COBAS INTEGRA Glucose Gen. 3 AssaySerum/Plasma Application (K061048) | ||||
|---|---|---|---|---|---|---|
| Precision - Urine | Urine – Regular Application:Repeatability (Within-Run Precision) | Urine:Within-Run Precision | ||||
| Sample | Mean (mg/dL) | CV (%) | Sample | Mean (mg/dL) | CV (%) | |
| HS1 | 8.65 | 2.28 | Level I | 15.0 | 1.35 | |
| HS2 | 17.3 | 1.05 | Level II | 43.6 | 0.64 | |
| HS3 | 672 | 0.53 | ||||
| PNU | 90.8 | 0.58 | ||||
| PPU | 247 | 0.59 | ||||
| Intermediate (Between Run Precision) | Between Run | |||||
| Sample | Mean (mg/dL) | CV (%) | Sample | Mean (mg/dL) | CV (%) | |
| HS1 | 8.65 | 2.83 | Level I | 15.1 | 0.75 | |
| HS2 | 17.3 | 1.37 | Level II | 43.8 | 0.83 | |
| HS3 | 672 | 1.01 | ||||
| PNU | 90.8 | 1.24 | ||||
| PPU | 247 | 1.21 | ||||
| Serum - Stat Application:Repeatability (Within-Run Precision) | ||||||
| Sample | Mean (mg/dL) | CV (%) | ||||
| HS1 | 8.58 | 2.71 | ||||
| HS2 | 17.4 | 1.16 | ||||
| HS3 | 476 | 0.64 | ||||
| PNU | 91.4 | 0.58 | ||||
| PPU | 249 | 0.57 | ||||
| Intermediate (Between Run Precision) | ||||||
| Sample | Mean (mg/dL) | CV (%) | ||||
| HS1 | 8.58 | 3.20 | ||||
| HS2 | 17.4 | 1.65 | ||||
| HS3 | 476 | 1.09 | ||||
| PNU | 91.4 | 1.15 | ||||
| PPU | 249 | 1.07 |
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·
Substantial
equivalence –
comparison
ノバイ
、
squares
comparison
| Feature | COBAS INTEGRA Glucose Gen. 3 AssaySerum/Plasma Application | Predicate Device: COBAS INTEGRA Glucose Gen. 3 AssaySerum/Plasma Application(K061048) | ||||
|---|---|---|---|---|---|---|
| Precision - CSF | CSF - Regular Application:Repeatability (Within-Run Precision) | CSF - Regular Application:Within-Run Precision | ||||
| Sample | Mean(mg/dL) | CV (%) | Sample | Mean(mg/dL) | CV (%) | |
| Level I | 57.7 | 1.13 | Level I | 57.7 | 1.13 | |
| Level II | 168 | 1.49 | Level II | 168 | 1.49 | |
| CSF - STAT Application:Repeatability (Within-Run Precision) | ||||||
| Sample | Mean(mg/dL) | CV (%) | ||||
| CSF 1 | 39.6 | 0.63 | ||||
| CSF 2 | 283 | 0.39 | ||||
| CSF 3 | 517 | 0.51 | ||||
| PNU Plus | 92.4 | 0.53 | ||||
| PPU Plus | 240 | 0.43 | ||||
| AnalyticalSensitivity | Lower Limits of Measurement:Limit of Blank = 2.16 mg/dLLimit of Detection = 4.32 mg/dL | Lower Detection Limit:2.16 mg/dL |
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Substantial
equivalence –
| comparison | ||
|---|---|---|
| Feature | COBAS INTEGRA Glucose Gen. 3AssaySerum/Plasma Application | Predicate Device: COBASINTEGRA Glucose Gen. 3 AssaySerum/Plasma Application(K061048) |
| Limitations -Interference | Icterus - No significant interference up toan I index of 60 (approximateconcentration of conjugated andunconjugated bilirubin: 60 mg/dL or1026 umol/L)* | Same |
| Hemolysis - No significant interferenceup to an H index of 1200 (approximatehemoglobin concentration: 1200 mg/dLor 744 umol/L)* | Same | |
| Lipemia – No significant interference upto an L index of 1900. There is a poorcorrelation between the L index(corresponds to turbidity) and thetriglyceride concentration.* | Same | |
| Other - In very rare cases gammopathy,in particular type IgM (Waldenstrom'smacroglobulinemia), may causeunreliable results. | Same | |
| Drugs - No interference was found attherapeutic concentrations using commondrug panels. | Not Specified | |
| *measured at a glucose concentrations ofapproximately 63.07 mg/dL and 297.33mg/dL | ||
| comparisonFeature | COBAS INTEGRA Glucose Gen. 3AssaySerum/Plasma Application | Predicate Device: COBASINTEGRA Glucose Gen. 3 AssaySerum/Plasma Application(K061048) |
| Expected Values | PlasmaFasting: 74 - 109 mg/dL(Per Thomas L. Blutglucose. In: Thomas L,ed. Labor und Diagnose, 6th ed.Frankfurt/Main: TH-Books, 2005:193-199.) | PlasmaFasting: 70 - 115 mg/dL(Per Thomas L, ed. Labor und Diagnose, 4thed. Marburg: Die medizinischeVerlagsgesellschaft 1992.) |
| Urine1st morning: 6 - 20 mg/dL24-h urine: 6 - 17 mg/dL(average of 1350 mL urine/24 h) | Same | |
| acc. to Tietz:Serum,PlasmaAdults: 74 - 106 mg/dL60-90 years: 82 - 115 mg/dL>90 years: 75 - 121 mg/dLChildren: 60 - 100 mg/dLNeonates (1 day): 40 - 60 mg/dLNeonates (>1 day): 50 - 80 mg/dL | Same | |
| Urine24-h urine: <0.5 g/24 hRandom Urine: 1 - 15 mg/dLCSFChildren: 60 - 80 mg/dLAdults: 40 - 70 mg/dL | Same | |
| MethodComparison -Serum | Glucose values for human serum samples obtained on a COBAS INTEGRA 800 analyzerwith the COBAS INTEGRA Glucose HK Gen. 3 reagent were compared to those determinedon the same analyzer with the same reagent, but with the Stat application.n=79 | |
| Passing Babloky=0.997x + 0.033 mmol/L$ \tau = 0.999 $SD (md 95) = 0.067 | Linear Regressiony=0.997x + 0.032 mmol/Lr=1.00Sy.x = 0.032 | |
| Feature | COBAS INTEGRA Glucose Gen. 3AssaySerum/Plasma Application | Predicate Device: COBASINTEGRA Glucose Gen. 3 AssaySerum/Plasma Application(K061048) |
| MethodComparison -Urine | Glucose values for human urine samples obtained on a COBAS INTEGRA 800 analyzerwith the COBAS INTEGRA Glucose HK Gen. 3 reagent were compared to those determinedon the same analyzer with the same reagent, but with the Stat application.n=50 | |
| Passing Bablok$y=1.00x + 0.002$ mmol/L$\tau = 0.996$SD (md 95) = 0.082 | Linear Regression$y=1.00x +0.003$ mmol/Lr=1.00Sy,x = 0.041 |
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Substantial
equivalence –
comparison
equivalence.
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Substantial
equivalence –
1 :
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Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
DEC 4, 2009
Roche Diagnostics c/o Kathie J Goodwin · Regulatory Affairs Consultant 9115 Hague Road, Po Box 50416 Indianapolis, IN 46250
Re: K092603
Trade/Device Name: Cobas Integra Glucose Hk Gen 3 Assay Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system. Regulatory Class: II Product Code: CFR Dated: November 3, 2009 Received: November 5, 2009
Dear: Ms. Goodwin:
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. Ilsting of devices, good manufacturing 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 can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
CFC
Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Form
510(k) Number (if known): Kog 3603
Device Name: COBAS INTEGRA Glucose HK Gen. 3 Assay
Indications for Use:
In vitro test for the quantitative determination of glucose in serum, plasma, urine and cerebrospinal fluid (CSF).
Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia and pancreatic islet cell tumors.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K092603
Page 1 of 1
§ 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.