The ACCU-CHEK Performa Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in venous whole blood or fresh capillary whole blood from the fingertips. The ACCU-CHEK Performa Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid in monitoring the effectiveness of glucose control. This system should only be used with single-use, auto-disabling lancing devices.

The ACCU-CHEK Performa Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. This system is also not for neonatal use.

The ACCU-CHEK Performa test strips are for use with the ACCU-CHEK Performa meter to quantitatively measure glucose (sugar) in venous whole blood or fresh capillary whole blood samples from the fingertips.

Device Description

The ACCU-CHEK Performa blood glucose monitoring system is a blood glucose monitoring system that makes use of the ACCU-CHEK Performa test strips, the ACCU-CHEK Performa meter, the ACCU-CHEK Inform II Control Solutions (cleared under K121679), and the ACCU-CHEK Inform II Linearity Test Kit (cleared under K121679). This system is a multi-patient use blood glucose monitoring system intended to be used in a professional environment to quantitatively measure glucose in venous whole blood and fresh capillary whole blood samples drawn from the fingertips.

AI/ML Overview

The ACCU-CHEK Performa Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in venous or fresh capillary whole blood. The system is for in vitro diagnostic use in professional healthcare settings and should only be used with single-use, auto-disabling lancing devices. It is not for the diagnosis or screening of diabetes, nor for neonatal use.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Not explicitly stated as criteria, but inferred from data presentation as performance targets)	Reported Device Performance (ACCU-CHEK Performa System)
Method Comparison (vs. YSI Glucose Analyzer):
For glucose concentrations < 75 mg/dL:
Within ±5 mg/dL	17/19 (89.5%)
Within ±10 mg/dL	18/19 (94.7%)
Within ±15 mg/dL	19/19 (100%)
For glucose concentrations ≥ 75 mg/dL:
Within ±5 %	50/86 (58.1%)
Within ±10 %	78/86 (90.7%)
Within ±15 %	84/86 (97.7%)
Within ±20 %	85/86 (98.8%)
Repeatability (Within Lot) Precision:
For targets < 75 mg/dL: SD ≤ 5.0 mg/dL	All reported SDs for means < 75 mg/dL (37.1 mg/dL) are 1.7 mg/dL, which is ≤ 5.0 mg/dL.
For targets ≥ 75 mg/dL: CV ≤ 5.0%	All reported CVs for means ≥ 75 mg/dL (81.1, 134.6, 216.2, 345.3 mg/dL) are 4.7%, 3.4%, 3.3%, 3.6%, 3.0% respectively, all are ≤ 5.0%.
Reproducibility (Intermediate/Day-to-Day) Precision:
(No specific criteria provided, but data is presented for comparison)	For control solutions:
	Low mean (45.8 mg/dL): SD 1.5 mg/dL, CV 3.2%
	Mid mean (118.8 mg/dL): SD 2.7 mg/dL, CV 2.3%
	High mean (310.8 mg/dL): SD 6.6 mg/dL, CV 2.1%

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

Sample Size for Method Comparison (Test Set):
- For glucose concentrations < 75 mg/dL: 19 samples.
- For glucose concentrations ≥ 75 mg/dL: 86 samples.
Sample Size for Repeatability Precision: 100 measurements per blood level (5 blood levels), totaling 500 measurements.
Sample Size for Reproducibility Precision: 100 measurements per control solution level (3 control levels), totaling 300 measurements.
Data Provenance: The document does not explicitly state the country of origin or whether the data is retrospective or prospective. It is implied to be prospective clinical and laboratory testing conducted in support of the 510(k) submission.

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

The document does not provide information on the number of experts, their qualifications, or their involvement in establishing ground truth for the test set. For blood glucose monitoring systems, the "ground truth" or reference method is typically a laboratory-based analyzer (e.g., YSI Glucose Analyzer), not expert consensus.

4. Adjudication Method for the Test Set

Not applicable. For blood glucose measurement, the comparison is typically against a highly accurate laboratory reference method, not an adjudicated clinical assessment.

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 a blood glucose monitoring system, which typically involves a single user and an automated reading, not a multi-reader visual interpretation task. There is no AI component described in the context of improving human reader performance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Yes, the performance data presented (method comparison, repeatability, reproducibility) represents the standalone performance of the device (ACCU-CHEK Performa Blood Glucose Monitoring System) against a laboratory reference standard (YSI Glucose Analyzer) and its own internal precision metrics. The device is designed for automated glucose measurement.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for the method comparison study was established using a "reference method" instrument, likely a YSI Glucose Analyzer, as is standard practice for blood glucose monitoring systems. Although not explicitly named in the results table, it's mentioned under "Results for glucose concentrations less than 75 mg/dL" and "Results for glucose concentrations greater than or equal to 75 mg/dL," implying comparison to a highly accurate laboratory analyzer.

8. The Sample Size for the Training Set

The document does not provide information on the sample size used for the training set. For blood glucose meters, "training" often refers to the calibration and algorithm development process by the manufacturer, which utilizes extensive internal data, but this data is not typically disclosed in 510(k) summaries in terms of sample size.

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

The document does not explicitly detail how the ground truth for any "training set" was established. However, for blood glucose meters, the development and calibration of the device's algorithms (which could be considered analogous to "training") would typically involve:

Measuring glucose levels in various blood samples using a highly accurate laboratory reference method (like a YSI Glucose Analyzer).
Using these reference values to calibrate the meter's internal algorithm to accurately translate the electrochemical signal from the test strip into a glucose concentration reading.
Extensive testing across various glucose ranges, hematocrit levels, and interfering substances.

Summary

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

Auqust 29, 2014

ROCHE DIAGNOSTICS NATHAN CARRINGTON DIRECTOR OF REGULATORY AFFAIRS 9115 HAGUE ROAD INDIANAPOLIS MD 46250

Re: K133741

Trade/Device Name: ACCU-CHEK Performa Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW. LFR Dated: July 25, 2014 Received: July 29, 2014

Dear Mr. Nathan Carrington:

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

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Indications for Use

510(k) Number (if known) K133741

Device Name

ACCU-CHEK Performa Blood Glucose Monitoring System

Indications for Use (Describe)

The ACCU-CHEK Performa Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. This system is also not for neonatal use.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

Introduction

According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.

1. Submitter Name, Address, Contact

Roche Diagnostic Corporation 9115 Hague Rd. Indianapolis, IN 46250 (317) 521-4793 Contact Person: Nathan Carrington Date Prepared: August 26, 2014

2. Device Name

Proprietary names:	ACCU-CHEK Performa System
	ACCU-CHEK Performa Test Strip
	ACCU-CHEK Performa Meter

Classification name: Glucose dehydrogenase, glucose test system (21 C.F.R. § 862.1345); Class II

NBW, Blood Glucose Test System, Over-the-Counter LFR, Glucose Dehydrogenase

3. Predicate Device

ACCU-CHEK Inform II System (K121679), concurrence received on 11 October 2012.

The ACCU-CHEK Inform II blood glucose monitoring system is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings.

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4. Device Description

The ACCU-CHEK Performa System consists of the following:

ACCU-CHEK Performa Meter
ACCU-CHEK Performa test strips ●
ACCU-CHEK Inform II control solutions (K121679) ●
ACCU-CHEK Inform II Linearity Test Kit (K121679)

The components of the ACCU-CHEK Performa blood glucose monitoring system are shown below:

Image /page/4/Picture/8 description: The image shows a blood glucose meter with labels pointing to different parts of the device. The front of the meter has a display screen that shows results, messages, and test results stored in memory. There are also right and left arrow buttons to enter memory, adjust settings, and scroll through results, as well as a test strip slot to insert the test strip. The back of the meter has an infrared window to transfer data to a computer, a power/set button to turn the meter on or off and set options, and a battery door that can be opened by pushing the tab in the direction of the arrow.

Code Kev Slot -Insert code kev into this opening.

510(k) Summary

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Image /page/5/Figure/0 description: The image shows different components of the ACCU-CHEK blood glucose monitoring system. These components include a test strip container, a test strip, a code key, a battery, and control and linearity solutions. The test strip has a yellow window where blood or control solution is applied, and the battery should be inserted with the (+) symbol facing up. The control and linearity solutions include ACCU-CHEK Inform II control solution levels 1-2 and ACCU-CHEK Inform II Linearity Test Kits containing linearity solution levels 1-6.

5. Intended Use

The ACCU-CHEK Performa Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. This system is also not for neonatal use.

6. Substantial Equivalence

The ACCU-CHEK Performa System is substantially equivalent to the ACCU-CHEK Inform II System. Below is a table that provides a comparison between the ACCU-CHEK Performa System and its predicate device.

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Similarities Table

System Feature/Claim	Detail
Test Strip	Same: The Performa and Inform II test strips are identical.
Test Strip ProductionProcesses and Lot-ReleaseCriteria	Same: The Performa and Inform II test strips are identical.
Meter firmware formeasurement sequence andblood glucose calculationalgorithm	Same: The fundamental scientific technology for themeasurement of blood glucose has not changed from thepredicate.
Meter Analog and Digitaldevice integrated circuitsused for glucosemeasurement	Same
Meter measurement enginemicroprocessor	Same
Underdose detection andsystem fail-safes	Same
Meter production site andassembly methodology	Same
Meter production test andcalibration methods	Same
Integrity Check for Strip	Same: Early in the measurement sequence, the metermeasures the resistance of the gold on the un-dosed strip toassure that it has been properly inserted and that the qualityis not compromised. The meter measures the backgroundconductivity and electrical current prior to dosing to assurethat the reagent quality is not compromised or that the stripwas not prematurely dosed.

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Similarities Table (continued)

SystemFeature/Claim	ACCU-CHEK Performa BloodGlucose Monitoring System	ACCU-CHEK Inform II BloodGlucose Monitoring SystemPredicate(K121679)
Indications forUse	Quantitative measurement ofglucose (sugar) in venous wholeblood or fresh capillary wholeblood samples.	Quantitative measurement ofglucose (sugar) in venous wholeblood, arterial whole blood,neonatal heelstick, or freshcapillary whole blood samples.
Test Principle	Amperometric Detection	Amperometric Detection
Enzyme	Mut. Q-GDH	Mut. Q-GDH
SampleHematocrit	10 to 65%	10 to 65%
MaximumAltitude	10,000 feet	10,000 feet
Sample Volume	0.6 µL	0.6 µL
Test Time	5 seconds	5 seconds
OperatingTemperature andRelativeHumidity	16 to 35°C(61 to 95°F)10 to 80% r.h.	16 to 35°C(61 to 95°F)10–80% r.h.
Coding	Lot-specific blood glucosemeasurement parameters areprogrammed into ROM code key	Lot-specific blood glucosemeasurement parameters areprogrammed into ROM key
Precision	For response targets below 75mg/dL, the SD is ≤ 5.0 mg/dL,and for response targets ≥ 75mg/dL, the CV is ≤ 5.0%.	For response targets below 75mg/dL, the SD is ≤ 5.0 mg/dL,and for response targets ≥ 75mg/dL, the CV is ≤ 5.0%.
Double Dosing	No	No
Alternate SiteTesting	No	No
SystemFeature/Claim	ACCU-CHEK Performa BloodGlucose Monitoring System	ACCU-CHEK Inform II BloodGlucose Monitoring SystemPredicate(K121679)
Closed and OpenVial Shelf LifeStability	18 months	18 months
Control Solutions	Aqueous, 2 levels, uses ACCU-CHEK Inform II ControlSolutions	Aqueous, 2 levels, uses ACCU-CHEK Infrom II ControlSolutions
Linearity Kit	Aqueous, 6 levels, uses ACCU-CHEK Inform II Linearity TestKit	Aqueous, 6 levels, uses ACCU-CHEK Inform II Linearity TestKit
PrimaryPackaging	Standard flip top vial	Standard flip top vial
Limitations ofProcedure	Galactose >15 mg/dL will causeoverestimation of blood glucoseresults.	Galactose >15 mg/dL will causeoverestimation of blood glucoseresults.
	Lipemic Samples >1800 mg/dL	Lipemic Samples >1800 mg/dL
	Intravenous administration ofascorbic acid which results inblood concentrations of ascorbicacid >3 mg/dL will causeoverestimation of blood glucoseresults	Intravenous administration ofascorbic acid which results inblood concentrations of ascorbicacid >3 mg/dL will causeoverestimation of blood glucoseresults

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Similarities Table (continued)

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Differences Table

SystemFeature/Claim	ACCU-CHEK Performa BloodGlucose Monitoring System	ACCU-CHEK Inform II BloodGlucose Monitoring SystemPredicate(K121679)
Meter PhysicalAppearanceIncluding Sizeand Weight	3.7 in x 2.1 in x 0.9 in (LWH),0.14 lbs93 mm x 52 mm x 22 mm(LWH), 62 g	7.60 in x 3.74 in x 1.73 in(LWH), 0.83 lbs193 mm x 95 mm x 44 mm(LWH), 376 g
Ergonomics ofUser Interface	Two buttons located on the faceof the meter; power button on topedge of the meter.	Power button located on the faceof the meter; touch-sensitivedisplay.
Code Key Port	Code key inserts directly intocode key slot in meter.	Code key inserts into code keyreader which transfers data tometer via IR communication
Battery	One 3-volt lithium type CR2032coin cell	3.7 V rechargeable battery pack(lithium technology)
DataManagementFeatures	Simplified for basic bloodglucose testing.	Additional firmware for addedfeatures, such as the tracking ofpatient information
Bar CodeScanner	None	Present
Transmission ofRetrospectiveData to ExternalDevices	None	Wirelessly to WLAN through RFcommunication or to dockingstation base unit through IR dataport
Measuring Range	20 – 600 mg/dL	10 – 600 mg/dL

7. Data demonstrating substantial equivalence

Performance testing on the ACCU-CHEK Performa System demonstrated that the device meets the performance requirements for its intended use. The data demonstrate that the system is substantially equivalent to the predicate device.

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Below is the method comparison data for the system:

Results for glucose concentrations less than 75 mg/dL

Within +5 mg/dL	Within +10 mg/dL	Within + 15 mg/dL
17/19 (89.5%)	18/19 (94.7%)	19/19 (100%)

Results for glucose concentrations greater than or equal to 75 mg/dL

Within +5 %	Within +10 %	Within + 15 %	Within + 20 %
50/86 (58.1%)	78/86 (90.7%)	84/86 (97.7%)	85/86 (98.8%)

Below is the repeatability (wtihin lot) precision for the system:

Blood	1	2	3	4	5
N	100	100	100	100	100
Mean [mg/dL]	37.1	81.1	134.6	216.2	345.3
SD [mg/dL]	1.7	2.7	4.4	7.9	10.2
CV [%]	4.7	3.4	3.3	3.6	3.0

Below is the reproducibility (intermediate or day-to-day) precision for the system:

Control solutions	Low	Mid	High
N	100	100	100
Mean [mg/dL]	45.8	118.8	310.8
SD [mg/dL]	1.5	2.7	6.6
CV [%]	3.2	2.3	2.1

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.