The Synermed Glucose Reagent is for the in vitro quantitative measurement of glucose in serum on the Synermed IR-1200 Chemistry Analyzer. Glucose measurements are used in the diagnosis and treatment of carbolygrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia and of pancreatic islet cell carcinoma.

The Synermed IR-1200 Chemistry Analyzer is intended for in vitro diagnostic use as a multiparameter chemistry instrument that quantitates the levels of constituents in serum. The analyzer is an automated, random eccess, computer controlled, clinical chemistry analyzer for clinical chemistry tests. The instrument provides in vitro quantitative measurements for glucose in serum. The device is intended for use only in clinical laboratories.

Device Description

Synermed IR-1200 Glucose Reagent

The Synermed Glucose is ready to use. The composition of the Synermed Glucose Oxidase Reagent is as follows: 280 umol/L N-sulfopropyl-N-ethyl-3, 5-dimethylaniline, 280 umol/L ampyrone, 1400 U/L peroxidase (horseradish) and 18,000 U/L glucose oxidase.

Synermed IR-1200 Chemistry Analyzer

The IR-1200 Chemistry Analyzer is a multiparameter chemistry instrument that quantitates the levels of analytes in serum using spectrophotometric measurement. The system uses Synermed liquid-stable reagent systems that have been previously cleared by FDA.

The IR-1200 Chemistry Analyzer is a discrete analyzer with STAT priority capabilities and an externalized computer. The instrument features a user-friendly software operating system, optical unit, precision pipetting and electronic system. Twelve wavelengths are included ranging from 340 nm to 800 nm. The instrument's capabilities include: sample pipetting, reagent pipetting, anti-interference, mixing, pre-heating, reaction monitoring, calculation, display and printing of results. After the measurement is complete, the system rinses and dries the cuvettes. The system automates the manual functions and, as a result, it enhances efficiency, diminishes errors, thus improving the accuracy and precision of test results.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Synermed Glucose Reagent and Synermed IR-1200 Chemistry Analyzer:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the performance of the Synermed Glucose Reagent on the Synermed IR-1200 Chemistry Analyzer. While it doesn't explicitly list "acceptance criteria" as a separate, pre-defined column, the "Results" sections and the discussions of "non-significant interference" imply the criteria used for evaluation. Therefore, I will reconstruct the table with implied acceptance criteria based on the reported results.

Study/Parameter	Implied Acceptance Criteria (Based on Study Description/Results)	Reported Device Performance
Precision/Reproducibility	CV% to be within acceptable limits (specific percentage not explicitly stated as 'criteria' but evaluated)	For glucose, CV% ranged from 0.09% to 1.2% (total precision) across different concentrations.
Linearity/Reportable Range	R² > 0.99 (common for linearity studies) and a linear relationship across the claimed measuring range.	R² = 0.9999 for glucose. Tested range: 6.5-900 mg/dL. Claimed range: 8-885 mg/dL.
Analytical Specificity (Interference)	Bias of < 10% between spiked and unspiked samples for non-significant interferents.	Identified ascorbic acid, methyldopa, ofloxacin, salicyluric acid, and uric acid as interferants at certain concentrations (bias ≥ 10%). Specific non-interfering concentrations are reported.
Detection Limit (LoB, LoD, LoQ)	LoB, LoD, LoQ to be within claimed measuring range (LoQ should be ≤ lower limit of claimed range).	LoB = 2.8 mg/dL, LoD = 3.65 mg/dL, LoQ = 8.0 mg/dL. Claimed range: 8-885 mg/dL.
Comparison Studies (Method Comparison)	High correlation (e.g., Coefficient > 0.98), slope close to 1, and intercept close to 0 when compared to a predicate device.	Correlation Coefficient = 0.9994, Slope = 0.988, Intercept = -0.178. Sample range tested: 15-885 mg/dL.

2. Sample Size Used for the Test Set and Data Provenance:

Precision/Reproducibility:
- Sample Size: 5 concentrations of pooled patient serum, with 80 measurements at each concentration (run in duplicate twice a day for twenty days). Total = 400 measurements (5 concentrations * 80 measurements/concentration). While 80 measurements per concentration are mentioned, it's 2 duplicates per day * 20 days.
- Data Provenance: Not explicitly stated, but "pooled patient serum" suggests human biological samples. No mention of country of origin or whether it was retrospective/prospective.
Linearity/Reportable Range:
- Sample Size: 13 concentrations across the measuring range, with four replicates at each concentration. Total = 52 measurements (13 concentrations * 4 replicates). Sample preparation involved "intermixing a high serum pool with a low serum pool."
- Data Provenance: Not explicitly stated. The use of "serum pool" implies human samples.
Analytical Specificity (Interference):
- Sample Size: Serum pools spiked with interferents at two analyte levels (80 mg/dL and 120 mg/dL glucose) and at two concentrations of interferent. Specific numbers of samples are not detailed beyond "serum pools."
- Data Provenance: Not explicitly stated. Use of "serum pools" implies human samples.
Detection Limit (LoB, LoD, LoQ):
- Sample Size: Not explicitly stated, but the study "evaluated following CLSI EP17-A" suggests a scientifically rigorous approach with sufficient replicates, though the exact number isn't provided.
- Data Provenance: Not explicitly stated.
Comparison Studies (Method Comparison):
- Sample Size: 115 samples for glucose. 15 of these were "modified to cover the entire claimed measuring range" by intermixing patient serum pools.
- Data Provenance: Not explicitly stated, but "patient serum pools" and "patient serum samples" indicate human biological samples. No mention of country of origin or whether it was retrospective/prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This document describes the performance of a quantitative laboratory diagnostic device (chemistry analyzer and reagent). For such devices, "ground truth" is typically established by:

Reference Methods: Highly accurate and precise laboratory methods, often traceable to international standards (e.g., NIST).
Predicate Devices: Comparison to an already FDA-cleared device provides a benchmark.

The studies presented here rely on these types of "ground truth":

For linearity, the "expected values" are derived from known dilutions.
For comparison studies, the "ground truth" is the measurement obtained from the predicate device (Hitachi 717 chemistry analyzer) using the same previously cleared reagent systems.

Therefore, no human experts were used to establish a subjective "ground truth" in the way they might be for interpreting medical images. The "ground truth" is analytical, derived from established laboratory methodologies and reference measurements. The Synermed IR Cal II calibrator is stated to be traceable to NIST standard number 917-C, which provides a form of metrological ground truth.

4. Adjudication Method for the Test Set:

Not applicable. As explained above, the "ground truth" is analytical/measurement-based, not based on human interpretation or consensus. There is no need for an adjudication method for these types of studies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This type of study involves multiple human readers interpreting cases/images, often with and without AI assistance, to assess the impact of AI on human performance. This document concerns a chemistry analyzer and reagents, which are distinct from image-based AI diagnostics.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, all presented studies are standalone (algorithm only). The Synermed IR-1200 Chemistry Analyzer is an automated instrument. The performance reported (precision, linearity, specificity, detection limits, method comparison) reflects the intrinsic analytical capabilities of the device itself, without human interpretation or intervention affecting the measurement results. The results are quantitative outputs directly from the instrument.

7. Type of Ground Truth Used:

The ground truth used is primarily measurement-based and comparative:

Reference Values/Standards: For linearity, expected values from known dilutions. For calibration, traceability to NIST standards.
Predicate Device Measurements: In the method comparison study, the measurements from the predicate Hitachi 717 chemistry analyzer serve as the comparative ground truth.
Defined Analytical Procedures: Ground truth for precision, linearity, and detection limit studies are established through rigorous adherence to CLSI (Clinical and Laboratory Standards Institute) protocols, which are industry standards for analytical validation.

8. Sample Size for the Training Set:

This document describes the validation of a chemistry analyzer and reagent, which are based on established chemical reactions and spectrophotometric measurements. There is no mention of a "training set" in the context of machine learning or AI model development because the device does not employ a learning algorithm that requires training. Its operational parameters are based on fixed scientific principles and engineering designs.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this type of device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

INFRARED LABORATORY SYSTEMS, LLC (DBA SYNERMED) JULIE PASCHAL REGULATORY AFFAIRS SPECIALIST 17408 TILLER COURT SUITE 1900 WESTFIELD IN 40674

June 24, 2016

Re: K153692

Trade/Device Name: Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer Regulation Number: 21 CFR 8862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: CGA, JJE Dated: June 20, 2016 Received: June 21, 2016

Dear Ms. Paschal:

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.

Katherine Serrano -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) K153692

Device Name Synermed Glucose Reagent Synermed IR-1200 Chemistry Analyzer

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

1. Company Information

Infrared Laboratory Systems, LLC 17408 Tiller Court Suite 1900 Westfield, Indiana 46074 Telephone; (317) 896-1565 FAX: (317) 896-1566

2. Contact Information

Julie Paschal Regulatory Affairs Specialist Telephone: 336-235-3057 Email: jpaschal(@slplabs.com

1. Date Prepared: June 20, 2016
1. Device Trade Name: Synermed Glucose Reagent; Synermed IR-1200 Chemistry Analyzer
1. Common Name: Glucose test system; Chemistry Analyzer
1. Classification Name: Glucose test, Class II; Discrete photometric chemistry analyzer for

clinical use, Class I

1. Classification Regulation: 21CFR862.1345, 21CFR862.2160

8. Classification Product Code: CGA, JJE

1. Panel: Chemistry (75)

10. Reagent Device Classification:

ProCode	ClassificationRegulation	Classification Name	Device Class	Panel
CGA	862.1345	Glucose test system	Class II	75
JJE	862.2160	Discrete photometricchemistry analyzer forclinical use	Class I	75

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K-number	Manufacturer	Product
K872494	BoehringerMannheimCorp (Roche)	Hitachi 717chemistryanalyzer
K903063	Synermed	SynermedGlucoseReagent

11. Identification of Predicates:

12. Device Description

Synermed IR-1200 Glucose Reagent

Synermed IR-1200 Chemistry Analyzer

13. Intended Use

Synermed Glucose Reagent

The Synermed Glucose Reagent is for the in vitro quantitative measurement of glucose on serum on the Synermed IR-1200. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and of pancreatic islet cell carcinoma.

Synermed IR-1200 Chemistry Analyzer

The Synermed IR-1200 analyzer is intended for in vitro diagnostic use as a multiparameter chemistry instrument that quantitates the levels of constituents in serum. The analyzer is an automated, random access, computer controlled, clinical chemistry analyzer for clinical chemistry tests. The instrument provides in vitro quantitative measurements for glucose in serum. The device is intended for use only in clinical laboratories.

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14. Comparison of Technological Characteristics with the Predicate Device

The new device is substantially equivalent to the predicate because it has the same intended use and has the same or similar technological characteristics including safety and effectiveness. The same specimen type can be analyzed and both analyzers use spectrophotometry to detect the amount of absorbance which is proportional to the concentration of the analyte in the specimen. Both analyzers wash and reuse PMMA cuvettes as well as use temperature ranges and the incubation for the reaction occurs at 37°C. Analyzer performance was quantified using the same previously cleared reagent systems.

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Items	Candidate Device: Synermed IR-1200 Chemistry Analyzer	Predicate Device:Roche/BoehringerMannheimHitachi 717ChemistryAnalyzer
	Similarity/Difference
Intended Use	The Synermed IR-1200 chemistry analyzeris an automated clinical analyzer for invitro diagnostic use only in clinicallaboratories. It is intended to be used for avariety of assay methods. The analyzerprovides in vitro quantitativedeterminations for glucose in serumsamples.	Same
Environment	Clinical laboratory use only	Same
Specimen	Serum	Same
Power	220 VAC, 50/60 Hz	115 VAC, 60 Hz
Analytical Methods	Endpoint, kinetic	Same
Calibration Methods	Linear and Nonlinear calibration	Same
Throughput (Max)	800 photometric tests/ hour	600 photometrictests/ hour
Calibration/QC	Programmable Cal/QC, will repeatautomatically if out of range	Same
Photometer wavelength	340-800 (12 wavelengths)	Same
Linear Absorbance Range	0-3.3 Absorbance	0-3.2 Absorbance
Reaction Cuvettes	Reusable PMMA (Polymethylmethacrylate)	Same
Lightpath	0.5cm	0.6cm
Sample Volume	1.5-35μL	1-20μL
Reagent Volume	15-350μL	50-350μL
Reaction Volume	120-450μL	250-400μL

Differences

The Synermed IR-1200 can use smaller reagent and sample volumes than the Hitachi 717. The Synermed IR-1200 is smaller and weighs less than the Hitachi 717. The Synermed IR-1200 can use up to 4 reagents to perform an analysis while the Hitachi 717 can only use 2 reagents.

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Items	Candidate Device: SynermedIR-1200 Glucose Reagent	Predicate Device: Synermed GlucoseReagent
Similarity/Difference
Intended Use	For the quantitativemeasurement of glucose inserum.	For the quantitative measurementof glucose in serum and plasma.
Test Principle	Oxidase	Same
Sample Type	Serum	Serum and Plasma
Measuring Range	8-885 mg/dL	Same

15. Summary of Performance Testing

The purpose of the performance studies was to validate that the previously cleared reagents have the same performance characteristics on the proposed new analyzer (Synermed IR-1200) as compared to the previously cleared Hitachi 717. The sponsor has chosen the representative analyte Glucose using serum as the representative sample matrix.

Analytical Performance

a. Precision/Reproducibility

Verification of precision on the Synermed IR-1200 was accomplished by implementing the study protocol laid out in CLSI document EP05-A3. Five concentrations of pooled patient serum were run for glucose. Each aliquot was run in duplicate twice a day for twenty days for a total of 80 measurements at each concentration. The mean, standard deviation and coefficient of variation were determined for glucose at each concentration. Additionally, the percentage of imprecision and total error was calculated. The results are displayed in the tables below.

Results:

	Within Run Precision		Total Precision
Mean(mg/dL glucose)	S.D.(mg/dL)	C.V.(%)	S.D.(mg/dL)	C.V.(%)
44.6	0.25	0.5%	0.5	1.2%
120.7	1.35	1.1%	1.7	1.4%
180.8	1.74	0.9%	2.1	1.1%
375.2	0.6	0.1%	0.8	0.2%
626.03	0.6	0.09%	0.8	0.1%

Figure 1 - Glucose Mean, Standard Deviation & %CV for all 80 Results

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b. Linearity/Reportable Range

Linearity studies were designed using CLSI EP06-A. Samples were prepared by intermixing a high serum pool with a low serum pool to obtain thirteen concentrations across the measuring range with four replicates at each concentration. The observed values were compared to the expected values and the results of linear regression are summarized below.

Linearity Results:

Measurand	Slope	Intercept	R2	Sample RangeTested	Claimed MeasuringRange
Glucose (mg/dL)	0.9928	1.3499	0.9999	6.5-900	8-885

Calibrators

The Synermed IR Cal II was previously cleared in K940571 and is traceable to NIST standard number 917-C; no modification was made.

c. Analytical Specificity

Interference studies were performed according to CLSI EP07-A2. Effects of common endogenous substances including bilirubin, hemoglobin, triglycerides and uric acid were evaluated by spiking serum pools with interferent at two analyte levels and at two concentrations of interferent. Additionally, common medications known to potentially affect the glucose assav were also tested at two analyte levels and at two concentrations of interferent. The sponsor defined significant interference as a bias of ≥=10% between the spiked and unspiked samples. Finally, any substance seen to interfere with the glucose assav was further studied using the dose-response procedure laid out on CLSI EP07-A2. Synermed will still reference in the product insert Young, D.S., Effects of Drugs on Clinical Laboratory Tests, 5th ed. Vol.2 AACC Press, Washington, D.C., 2000. The test results are summarized below:

Effects of common endogenous substances including conjugated bilirubin (0.76 and 20 mg/dL), unconjugated bilirubin (0.76 and 20mg/dL), hemoglobin (100 and 500 mg/dL), triglycerides (176.99 and 3274.34mg/dL) and uric acid (11.77 and 23.54mg/dL) were evaluated at two different glucose concentrations (80 mg/dL and 120 mg/dL) for interference. Furthermore, the following exogenous substances: ascorbic acid (1.22 and 6.02mg/dL), acetaminophen (20.11 and 200.18ug/mL), genatmicin (7.51 and 10.05ug/mL), ibuprofen (40.08 and 500.21ug/mL), L-dopa (0.41 and 1.24µg/ml/L), methyldopa (4.24 and 14.99µg/mL), N-acetylcysteine (0.08 and 0.25mg/dL), ofloxacin (8.78 and 17.5mg/L), salicyluric acid 0.2 and 0.6ug/mL), tetracycline (3.78 and 16.27ug.mL) were evaluated at two different glucose concentrations (80 mg/dL and 120 mg/dL) for interference. The sponsor defined non-significant interference when the bias between the tested and control samples are within +/-10%.

The sponsor identified ascorbic acid, methyldopa, levofloxacin, salicyluric acid, uric acid as interferants (see table).

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Figure 2 - Results Summary, Dose-Response

The Synermed Glucose measurement procedure was evaluated for interference according to CLSI document EP07-A2. The following study results demonstrate that the following substances do not interfere with the Synermed Glucose assay at the highest concentration listed. A bias of < 9.99% is considered non-significant interference. *

Interfering Substance	Highest Tested Concentration ofSubstance Without SignificantInterference at GlucoseConcentration = 80mg/dL	Highest Tested Concentration ofSubstance Without SignificantInterference at GlucoseConcentration = 120mg/dL
Ascorbic Acid	4.82mg/dL	4.82mg/dL
Methyldopa	12.31µg/mL	12.31µg/mL
Ofloxacin	8.78mg/L	8.78mg/L
Salicyluric Acid	0.5µg/mL	0.6µg/mL
Uric Acid	20.6mg/dL	20.6mg/dL

*Upper limit of 95% confidence interval.

Glucose

Significant interference from uric acid was observed when testing at both concentrations of glucose. Additionally, significant interference was seen with the following exogenous substances: ascorbic acid, methyldopa and salicyluric acid. See table below:

Interferent	InterferentConcentration	% BiasSeen atGlucose80mg/dL	% BiasSeen atGlucose120mg/dL
AscorbicAcid	6.02mg/dL	-11.7	-13.0
Methyldopa	14.99ug/mL	-10	-11.1
SalicyluricAcid	0.6ug/mL	-13.7	-8.7 *notsignificant
Uric Acid	23.54mg/dL	-10.7	-11.5

Figure 3 – Significant Interferents and Their Bias

d. Detection Limit

Refer to the linearity data for the linearity results used to support the measuring range. Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantitation (LoQ) were evaluated following CLSI EP17-A. Results are summarized in the table below.

Results:

Measurand	LoB	LoD	LoQ	ClaimedRange
Glucose (Serum) (mg/dL)	2.8	3.65	8.0	8-885

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e. Comparison Studies

Method comparison was performed according to CLSI EP09-A3, 115 samples for glucose were tested on the IR-1200 and Hitachi 717 chemistry analyzers. Thirteen percent (15 of the 115) samples studied were modified to cover the entire claimed measuring range. Modification of samples was obtained by intermixing patient serum pools with disparate results.

Results:

Test	SampleType	Total #Samples	SampleRangeTested	ClaimedMeasuringRange	Slope	Intercept	CorrelationCoefficient
Glucose mg/dL	Serum	115	15-885	8-885	0.988	-0.178	0.9994

16. Expected Values/Reference Range

The sponsor has provided the following Expected Values in labeling: Glucose: 74-106 mg/dL

References:

Tietz NW, editor: Fundamentals of Clinical Chemistry, 6th ed., WB Saunders Co., PA, 2008.

17. Conclusions

The new device is substantially equivalent to the predicate because it has the same intended use and has the same or similar technological characteristics that do not raise new types of questions of safety and effectiveness.

Regulation Number and Section

§ 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.