K Number
K133741
Device Name
ACCU-CHEK Performa Blood Glucose Monitoring System
Manufacturer
Date Cleared
2014-08-29

(263 days)

Product Code
Regulation Number
862.1345
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
More Information

ACCU-CHEK Inform II System (K121679)

Not Found

No
The summary describes a standard blood glucose monitoring system based on chemical reaction and electrical measurement, with no mention of AI or ML.

No.
The device is used for quantitative measurement of glucose as an aid in monitoring the effectiveness of glucose control. It is a diagnostic device, not a therapeutic one.

Yes

The device measures glucose levels to aid in monitoring the effectiveness of glucose control. Although it explicitly states it should not be used for diagnosis or screening for diabetes, monitoring glucose levels is a direct diagnostic process related to diabetes management.

No

The device description explicitly states it 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... and the ACCU-CHEK Inform II Linearity Test Kit". This indicates the system includes hardware components (meter, test strips, control solutions, linearity test kit) in addition to any potential software.

Yes, the provided text explicitly states that the ACCU-CHEK Performa Blood Glucose Monitoring System is an IVD (In Vitro Diagnostic).

The "Intended Use / Indications for Use" section clearly states: "The ACCU-CHEK Performa Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use)..."

N/A

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

NBW, LFR

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.

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

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.

The system also includes a code kev slot to insert the code key.

Other 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

fingertips

Indicated Patient Age Range

Not for neonatal use.

Intended User / Care Setting

multiple-patient use in professional healthcare settings

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Method comparison data:
Results for glucose concentrations less than 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%)

Results for glucose concentrations greater than or equal to 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 the system (N=100 for each blood level):
Blood 1: Mean = 37.1 mg/dL, SD = 1.7 mg/dL, CV = 4.7%
Blood 2: Mean = 81.1 mg/dL, SD = 2.7 mg/dL, CV = 3.4%
Blood 3: Mean = 134.6 mg/dL, SD = 4.4 mg/dL, CV = 3.3%
Blood 4: Mean = 216.2 mg/dL, SD = 7.9 mg/dL, CV = 3.6%
Blood 5: Mean = 345.3 mg/dL, SD = 10.2 mg/dL, CV = 3.0%

Reproducibility (intermediate or day-to-day) precision for the system (N=100 for each control solution level):
Low control solution: Mean = 45.8 mg/dL, SD = 1.5 mg/dL, CV = 3.2%
Mid control solution: Mean = 118.8 mg/dL, SD = 2.7 mg/dL, CV = 2.3%
High control solution: Mean = 310.8 mg/dL, SD = 6.6 mg/dL, CV = 2.1%

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

ACCU-CHEK Inform II System (K121679)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 862.1345 Glucose test system.

(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

0

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.

1

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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 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.

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)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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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.

4

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 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.

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

5

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 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.

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/ClaimDetail
Test StripSame: The Performa and Inform II test strips are identical.
Test Strip Production
Processes and Lot-Release
CriteriaSame: The Performa and Inform II test strips are identical.
Meter firmware for
measurement sequence and
blood glucose calculation
algorithmSame: The fundamental scientific technology for the
measurement of blood glucose has not changed from the
predicate.
Meter Analog and Digital
device integrated circuits
used for glucose
measurementSame
Meter measurement engine
microprocessorSame
Underdose detection and
system fail-safesSame
Meter production site and
assembly methodologySame
Meter production test and
calibration methodsSame
Integrity Check for StripSame: Early in the measurement sequence, the meter
measures the resistance of the gold on the un-dosed strip to
assure that it has been properly inserted and that the quality
is not compromised. The meter measures the background
conductivity and electrical current prior to dosing to assure
that the reagent quality is not compromised or that the strip
was not prematurely dosed.

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Similarities Table (continued)

| System
Feature/Claim | ACCU-CHEK Performa Blood
Glucose Monitoring System | ACCU-CHEK Inform II Blood
Glucose Monitoring System
Predicate
(K121679) |
|------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | Quantitative measurement of
glucose (sugar) in venous whole
blood or fresh capillary whole
blood samples. | Quantitative measurement of
glucose (sugar) in venous whole
blood, arterial whole blood,
neonatal heelstick, or fresh
capillary whole blood samples. |
| Test Principle | Amperometric Detection | Amperometric Detection |
| Enzyme | Mut. Q-GDH | Mut. Q-GDH |
| Sample
Hematocrit | 10 to 65% | 10 to 65% |
| Maximum
Altitude | 10,000 feet | 10,000 feet |
| Sample Volume | 0.6 µL | 0.6 µL |
| Test Time | 5 seconds | 5 seconds |
| Operating
Temperature and
Relative
Humidity | 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 glucose
measurement parameters are
programmed into ROM code key | Lot-specific blood glucose
measurement parameters are
programmed into ROM key |
| Precision | For response targets below 75
mg/dL, the SD is ≤ 5.0 mg/dL,
and for response targets ≥ 75
mg/dL, the CV is ≤ 5.0%. | For response targets below 75
mg/dL, the SD is ≤ 5.0 mg/dL,
and for response targets ≥ 75
mg/dL, the CV is ≤ 5.0%. |
| Double Dosing | No | No |
| Alternate Site
Testing | No | No |
| System
Feature/Claim | ACCU-CHEK Performa Blood
Glucose Monitoring System | ACCU-CHEK Inform II Blood
Glucose Monitoring System
Predicate
(K121679) |
| Closed and Open
Vial Shelf Life
Stability | 18 months | 18 months |
| Control Solutions | Aqueous, 2 levels, uses ACCU-
CHEK Inform II Control
Solutions | Aqueous, 2 levels, uses ACCU-
CHEK Infrom II Control
Solutions |
| Linearity Kit | Aqueous, 6 levels, uses ACCU-
CHEK Inform II Linearity Test
Kit | Aqueous, 6 levels, uses ACCU-
CHEK Inform II Linearity Test
Kit |
| Primary
Packaging | Standard flip top vial | Standard flip top vial |
| Limitations of
Procedure | Galactose >15 mg/dL will cause
overestimation of blood glucose
results. | Galactose >15 mg/dL will cause
overestimation of blood glucose
results. |
| | Lipemic Samples >1800 mg/dL | Lipemic Samples >1800 mg/dL |
| | Intravenous administration of
ascorbic acid which results in
blood concentrations of ascorbic
acid >3 mg/dL will cause
overestimation of blood glucose
results | Intravenous administration of
ascorbic acid which results in
blood concentrations of ascorbic
acid >3 mg/dL will cause
overestimation of blood glucose
results |

8

Similarities Table (continued)

9

Differences Table

| System
Feature/Claim | ACCU-CHEK Performa Blood
Glucose Monitoring System | ACCU-CHEK Inform II Blood
Glucose Monitoring System
Predicate
(K121679) |
|-----------------------------------------------------------------|--------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| Meter Physical
Appearance
Including Size
and Weight | 3.7 in x 2.1 in x 0.9 in (LWH),
0.14 lbs
93 mm x 52 mm x 22 mm
(LWH), 62 g | 7.60 in x 3.74 in x 1.73 in
(LWH), 0.83 lbs
193 mm x 95 mm x 44 mm
(LWH), 376 g |
| Ergonomics of
User Interface | Two buttons located on the face
of the meter; power button on top
edge of the meter. | Power button located on the face
of the meter; touch-sensitive
display. |
| Code Key Port | Code key inserts directly into
code key slot in meter. | Code key inserts into code key
reader which transfers data to
meter via IR communication |
| Battery | One 3-volt lithium type CR2032
coin cell | 3.7 V rechargeable battery pack
(lithium technology) |
| Data
Management
Features | Simplified for basic blood
glucose testing. | Additional firmware for added
features, such as the tracking of
patient information |
| Bar Code
Scanner | None | Present |
| Transmission of
Retrospective
Data to External
Devices | None | Wirelessly to WLAN through RF
communication or to docking
station base unit through IR data
port |
| 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/dLWithin +10 mg/dLWithin + 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:

Blood12345
N100100100100100
Mean [mg/dL]37.181.1134.6216.2345.3
SD [mg/dL]1.72.74.47.910.2
CV [%]4.73.43.33.63.0

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

Control solutionsLowMidHigh
N100100100
Mean [mg/dL]45.8118.8310.8
SD [mg/dL]1.52.76.6
CV [%]3.22.32.1