(61 days)
Not Found
No
The description focuses on affinity chromatography and standard laboratory performance metrics, with no mention of AI/ML terms or methodologies.
No
The device is an in-vitro diagnostic test intended for quantitative determination of HbA₁c to monitor blood glucose levels in diabetics, not to treat a condition.
Yes
The device is intended for the quantitative determination of HbA1c, which is used by diabetics for monitoring blood glucose levels. This determination provides information crucial for the diagnosis and management of the disease, fitting the definition of a diagnostic device.
No
The device description explicitly states it is an "Instrument read, single use in vitro test," indicating it involves physical components (test cartridges and a reader instrument) in addition to any potential software for data processing or display.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states the intended use is for the "in-vitro quantitative determination of HbA₁c". "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs. It also specifies the sample type (blood) and the purpose (monitoring blood glucose levels in diabetics).
- Device Description: The description clearly labels it as an "in vitro test".
- Sample Type: The device uses blood samples (capillary or whole blood), which are biological specimens tested outside the body.
These points align directly with the definition of an In Vitro Diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or treatment.
N/A
Intended Use / Indications for Use
G5 I HbA₁c Test: The G5 I HbA₁c assay is an affinity chromatography method and is intended for the in-vitro quantitative determination of HbA₁c in capillary blood taken from a finger prick or whole blood in EDTA. The test is indicated for use by diabetics for monitoring the time averaged blood glucose levels of known diabetics as an indicator of overall glycaemic control. The G5 I HbA₁c assay is intended for use in a physicians/doctors office. The assay is not intended for use as a home use or for self-testing.
G5 II HbA1c Test: The G5 II HbA1c assay is an affinity chromatography method and is intended for the in-vitro quantitative determination of HbA1c in capillary blood taken from a finger prick. The test is indicated for use by diabetics for monitoring the time averaged blood glucose levels of known diabetics as an indicator of overall glycaemic control. The G5 II HbA1c assay is intended for use as a prescription home use test.
Product codes (comma separated list FDA assigned to the subject device)
LCP, GGM
Device Description
G5 I HbA₁c Test: Instrument read, single use in vitro test for the quantitative determination of glycated haemoglobin (GHb) in diabetics. The G5 I HbA1c Test System consists of the HbA1c test cartridge, the G5 Instrument, the G5 System Check Cartridge and the G5 HbA1c Quality Controls.
G5 II HbA1c Test: Instrument read, single use in vitro test for the quantitative determination of glycated haemoglobin (GHb) in diabetics. The G5 II HbA1c Test System consists of the HbA1c test cartridge, the G5 Instrument, the G5 System Check Cartridge and the G5 HbA1c Quality Controls.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Human Whole Blood (capillary blood from a finger prick or whole blood in EDTA)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
G5 I HbA₁c Test: physicians/doctors office
G5 II HbA1c Test: prescription home use
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)
Clinical Studies:
Clinical trial carried out at Southport DGH, UK to evaluate a rapid blood test for the measurement of Glycated protein in subjects with type I and type II diabetes mellitus. The data from 74 patients demonstrated that the G5 HbAre assay is substantially equivalent to the Glycosal assay with a correlation coefficient of 0.96 for fresh finger prick and 0.97 for stored EDTA blood.
POL Studies (G5 I):
Evaluation of the G5 HbAie test using non-laboratory participants. Three separate Physician Office Laboratory (POL) studies were carried out. Each consisting of 5 standards run in triplicate and at least 20 blood samples (EDTA stored blood and/or fresh finger prick) run by a trained operator and an untrained operator. Each site produced acceptable data for accuracy and precision, with correlation coefficients of >0.95. accuracy within ± 10% and CV less than 4.6%.
Home Use - Consumer Study (G5 II):
This study took place at 3 separate sites in the USA and compared untrained subjects to trained subjects. The untrained subjects using only the supplied packaging achieved acceptable correlation to the trained operators.
Non Clinical Laboratory Studies:
- Assessing the linearity of the G5 HbAir assay: A study was conducted to prove the G5 HbA1c is linear over the assay range. Results demonstrated that the assay is linear between 6 and 14% HbAIc.
- The effect of Haemoglobinopathies on the G5 HbA1c assay: This validation is covered by reference WG John. Glycated haemoglobin analysis. Ann Clin Biochem 1997; 34: 17-31. Boronate methodology is not affected by HbS, HbC. HbF or by high levels of carbamylated haemoglobin in Uremic patients.
- The Effect of Abnormal blood chemistries upon the accuracy of the GS HbA1c assay: The effect of abnormal blood chemistries, i e. raised lipids and raised bilirubin upon the determination of %HbAir needed to be investigated. Triglycerides up to 4.0 mmol/L and Bilirubin up to 345 umol/L do not affect the test result.
- The Effect of Interfering Drugs upon Accuracy of the G5 HbA1c assay: The effect of the commonly prescribed pharmaceutical drugs (aspirin, paracetemol, caffeine and anti-histamine) upon the performance of the G5 HbA1c test needed to be assessed. None of the listed compounds affected the HbA1c test result.
- Investigating the effect of labile HbA1c on the G5 HbA1c assay: This validation is covered by reference WG John. Glycated haemoglobin analysis. Ann Clin Biochem 1997: 34: 17-31. Boronate Methodology is not affected by Labile HbAic:
- Investigating the analysis of variance of reproducibility of the G5 HbA1c assay: A study was performed to investigate the analysis of variance of reproducibility of the G5 HbA1c assay. Using a normal and an abnormal control, which were assayed in duplicate twice during each day over a period of 20 days, it was demonstrated that the variance was acceptable, with an overall CV precision of less than 5%.
- Investigating the assay reproducibility (Inter batch variation) of the G5 HbA1c ASSAY: A study was performed to determine the intra and inter batch variation of the G5 HbAic assay. Using 3 %HbAic standards on 3 batches of G5 devices it was demonstrated that the G5 assay was acceptable in terms of repeatability and reproducibility with assay %CV's of less than 5%.
- Investigation into the use of stored blood for the G5 HbAic assay: It was demonstrated that the assay can be run acceptably with fresh finger prick, EDT A blood for up to 4 days after collection when the blood is stored at 2-8°C.
- Investigating the effect of Total Haemoglobin and Haematocrit on the G5 HDAit ASSAV: Results demonstrated that the assay performs acceptably within a haemoglobin range of 11-18g/dl and a haematocrit range of 35% to 55%.
- G5 HbA1c test cartridge stability: Results demonstrated that the assav is stable for at least 12 months at 2-8°C.
- Assessing the time required to equilibrate the G5 device to room temperature from 2-8°C: The results demonstrated that the minimum time required for equilibration is 2 hours.
- Assessing the acceptable time a device can be left after sample addition prior to insertion into the G5 reader: The results demonstrated that the device needed to be inserted immediately after sample addition.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation coefficient of 0.96 for fresh finger prick and 0.97 for stored EDTA blood in clinical studies.
Correlation coefficients of >0.95, accuracy within ± 10% and CV less than 4.6% in POL studies.
Overall CV precision of less than 5% for reproducibility.
Assay %CV's of less than 5% for inter batch variation.
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.
The Glycosal HbA₁c Test (for G5 I HbA₁c Test), Glycosal II HbA1c Test (for G5 II HbA1c Test)
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.
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
§ 864.7470 Glycosylated hemoglobin assay.
(a)
Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.(b)
Classification. Class II (performance standards).
0
| 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 | Owner/ Operator
Provalis Diagnostics Limited
Newtech Square
Deeside Industrial Park
Deeside
Flintshire CH5 2NT
UK | | |
| Contact Person: | Mrs Jan Barrack, Regulatory Affairs Manager | | |
| Telephone: | +44 1244 288888 | | |
| Facsimile: | +44 1244 833441 | | |
| Email: | JanBarrack@Provalis.com | | |
| USA contact person Tom Tsakeris | | | |
| Company | Devices and Diagnostics Consulting Group, Inc | | |
| Address: | 16809 Briardale Road,
Rockville,
MD 20855
USA | | |
| Telephone: | 301 330 2076 | | |
| Facsimile: | 301 330 2568 | | |
| Email: | DDCGI@Comcast.net | | |
| Date Prepared | 5th June 2004 | | |
1
| 2) Device name | Proprietary name: | G5 I HbA₁c Test |
|---|---|---|
| Common name: | Laboratory test for the detection of | |
| Glycated Haemoglobin in Human Whole | ||
| Blood. | ||
| Classification: | ASSAY, GLYCOSYLATED | |
| HAEMOGLOBIN | ||
| 3) Predicate | ||
| Device | The G5 I HbA₁c test is substantially equivalent to | |
| other products in commercial distribution for similar use, | ||
| including the Glycosal HbA₁c Test. | ||
| 4) Device | ||
| Description | Instrument read, single use in vitro test for the quantitative | |
| determination of glycated haemoglobin (GHb) in diabetics. | ||
| 5) Intended use | The G5 I HbA₁c assay is an affinity chromatography method | |
| and is intended for the in-vitro quantitative determination of | ||
| HbA₁c in capillary blood taken from a finger prick or whole | ||
| blood in EDTA. | ||
| The test is indicated for use by diabetics for monitoring the time | ||
| averaged blood glucose levels of known diabetics as an | ||
| indicator of overall glycaemic control. | ||
| The G5 I HbA₁c assay is intended for use in a | ||
| physicians/doctors office. The assay is not intended for use as a | ||
| home use or for self-testing. |
:
2
.
| 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. | | |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| 2) Submitter
name, address,
contact | Owner/ Operator
Provalis Diagnostics Limited
Newtech Square
Deeside Industrial Park
Deeside
Flintshire CH5 2NT
UK | | |
| Contact Person: | Mrs Jan Barrack, Regulatory Affairs Manager | | |
| Telephone: | +44 1244 288888 | | |
| Facsimile: | +44 1244 833441 | | |
| Email: | JanBarrack@Provalis.com | | |
| USA contact person Tom Tsakeris | | | |
| Company | Devices and Diagnostics Consulting Group, Inc | | |
| Address: | 16809 Briardale Road,
Rockville,
MD 20855
USA | | |
| Telephone: | 301 330 2076 | | |
| Facsimile: | 301 330 2568 | | |
| Email: | DDCGI@Comcast.net | | |
| Date Prepared | 5th June 2004 | | |
・
029
l
:
3
| 2) Device name | Proprietary name: G5 II HbA1c Test
Common name: Prescription Home Use Test for the detection of Glycated Haemoglobin in Human Whole Blood.
Classification: ASSAY, GLYCOSYLATED HAEMOGLOBIN |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 5) Predicate Device | The G5 II HbA1c test is substantially equivalent to other products in commercial distribution for similar use, including the Glycosal II HbA1c Test for prescription home use. |
| 6) Device Description | Instrument read, single use in vitro test for the quantitative determination of glycated haemoglobin (GHb) in diabetics. |
| 5) Intended use | The G5 II HbA1c assay is an affinity chromatography method and is intended for the in-vitro quantitative determination of HbA1c in capillary blood taken from a finger prick
The test is indicated for use by diabetics for monitoring the time averaged blood glucose levels of known diabetics as an indicator of overall glycaemic control.
The G5 II HbA1c assay is intended for use as a prescription home use test. |
Continued on next page
、
፡
4
Technological Similarities and Differences of the G5 I HbA1c and G5 II HbA1c tests to the Predicate Devices ..............................................................................................................................................................................
| Characteristic | Candidate Device
G5 I and G5 II HbA1c test | Primary Predicate
Device for G5 I
Glycosal™ HbA1c test | Primary Predicate
Device for G5 II
Glycosal™ II HbA1c test |
|---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Quantitative measurement
of the percent of Glycated
Hemoglobin. | Quantitative
measurement of the
percent of Glycated
Hemoglobin. | Quantitative measurement
of the percent of Glycated
Hemoglobin. |
| Indications for
Use | Used in the management
and treatment of Diabetes,
for monitoring long term
glycemic control. | Used in the management
and treatment of
Diabetes, for monitoring
long term glycemic
control. | Used in the management
and treatment of Diabetes,
for monitoring long term
glycemic control. |
| Risk to Patient | Not a critical analyte -
reflects glucose
monitoring over time | Not a critical analyte -
reflects glucose
monitoring over time | Not a critical analyte -
reflects glucose
monitoring over time |
| Detects | Glycated Hemoglobin
(GHb) | Glycated Hemoglobin
(GHb) | Glycated Hemoglobin
(GHb) |
| Methodology | Rapid Affinity
Chromatography test | Rapid Affinity
Chromatography test | Rapid Affinity
Chromatography test |
| Does the Device
perform a
Diagnostic
Interpretation? | No | No | No |
| Quantitative
Test? | Yes | Yes | Yes |
| Calibration | Not required by end-user;
each instrument is factory
calibrated | Not required by end-
user; each instrument is
factory calibrated | Not required by end-user;
each instrument is factory
calibrated |
| Total Test time
Procedural Steps | 7 minutes
- Add sample
- Place device in
instrument - Record result | 4 minutes
- Add sample
- Incubate sample for
60 seconds. - Pour sample
- Wash
- Elute fraction
- Record result | 4 minutes
- Add sample
- Incubate sample for 60
seconds - Pour sample
- Wash
- Elute fraction
- Record result |
| Visual Display
Testing
Environment | LCD readout
Physicians office/Doctors
Office (G5 I)
Prescription Home Use
(G5 II) | LCD readout
Physicians
Office/Doctors Office | LCD readout
Prescription Home Use
Patient Labelling |
:
,
5
6) Performance Characteristics
Clinical Studies
Clinical trial carried out at Southport DGH, UK to evaluate a rapid blood test for the measurement of Glycated protein in subjects with type I and type II diabetes mellitus
The data from 74 patients demonstrated that the G5 HbAre assay is substantially equivalent to the Glycosal assay with a correlation coefficient of 0.96 for fresh finger prick and 0.97 for stored EDTA blood.
POL Studies (G5 I)
..............................................................................................................................................................................
Evaluation of the G5 HbAie test using non-laboratory participants
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Three separate Physician Office Laboratory (POL) studies were carried out. Each consisting of 5 standards run in triplicate and at least 20 blood samples (EDTA stored blood and/or fresh finger prick) run by a trained operator and an untrained operator. Each site produced acceptable data for accuracy and precision, with correlation coefficients of >0.95. accuracy within ± 10% and CV less than 4.6%.
Home Use - Consumer Study (G5 II)
This study took place at 3 separate sites in the USA and compared untrained subjects to trained subjects. The untrained subjects using only the supplied packaging achieved acceptable correlation to the trained operators.
Non Clinical Laboratory Studies
Assessing the linearity of the G5 HbAir assay
A study was conducted to prove the G5 HbA1c is linear over the assay range. Results demonstrated that the assay is linear between 6 and 14% HbAIc.
The effect of Haemoglobinopathies on the G5 HbA1c assay
This validation is covered by reference WG John. Glycated haemoglobin analysis. Ann Clin Biochem 1997; 34: 17-31. Boronate methodology is not affected by HbS, HbC. HbF or by high levels of carbamylated haemoglobin in Uremic patients.
The Effect of Abnormal blood chemistries upon the accuracy of the GS HbA1c assay
in and the contraction of the contribution of the comments of the comments of the comments of the comments of the contribution of the many of the comments of the contribution
The effect of abnormal blood chemistries, i e. raised lipids and raised bilirubin upon the determination of %HbAir needed to be investigated. Triglycerides up to 4.0 mmol/L and Bilirubin up to 345 umol/L do not affect the test result.
6
The Effect of Interfering Drugs upon Accuracy of the G5 HbA1c assay
The effect of the commonly prescribed pharmaceutical drugs (aspirin, paracetemol, caffeine and anti-histamine) upon the performance of the G5 HbA1c test needed to be assessed. None of the listed compounds affected the HbA1c test result.
Investigating the effect of labile HbA1c on the G5 HbA1c assay
This validation is covered by reference WG John. Glycated haemoglobin analysis. Ann Clin Biochem 1997: 34: 17-31. Boronate Methodology is not affected by Labile HbAic:
Investigating the analysis of variance of reproducibility of the G5 HbA1c assay
A study was performed to investigate the analysis of variance of reproducibility of the G5 HbA1c assay. Using a normal and an abnormal control, which were assayed in duplicate twice during each day over a period of 20 days, it was demonstrated that the variance was acceptable, with an overall CV precision of less than 5%.
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Investigating the assay reproducibility (Inter batch variation) of the G5 HbA1c ASSAY
A study was performed to determine the intra and inter batch variation of the G5 HbAic assay. Using 3 %HbAic standards on 3 batches of G5 devices it was demonstrated that the G5 assay was acceptable in terms of repeatability and reproducibility with assay %CV's of less than 5%.
Investigation into the use of stored blood for the G5 HbAic assay
The effect of running G5 assays with stored whole blood (EDTA) needed to be examined to assess the use of stored whole blood as an alternative to fresh finger pricks. It was demonstrated that the assay can be run acceptably with fresh finger prick, EDT A blood for up to 4 days after collection when the blood is stored at 2-8°C.
Investigating the effect of Total Haemoglobin and Haematocrit on the G5 HDAit ASSAV
The effect of the variation in total haemoglobin and haematocrit on %HbAre needed to be established. Results demonstrated that the assay performs acceptably within a haemoglobin range of 11-18g/dl and a haematocrit range of 35% to 55%.
G5 HbA1c test cartridge stability
The stability of the G5 HbA1c assay needed to be established. Results demonstrated that the assav is stable for at least 12 months at 2-8°C.
7
Assessing the time required to equilibrate the G5 device to room temperature from 2-8°C
The minimum time required to equilibrate the G5 devices to room temperature before use needed to be established. The results demonstrated that the minimum time required for equilibration is 2 hours.
Assessing the acceptable time a device can be left after sample addition prior to insertion into the G5 reader
The acceptable time a device can be left after sample addition prior to insertion into the G5 reader needed to be assessed. The results demonstrated that the device needed to be inserted immediately after sample addition
G5 HbAre Quality Control Kit
Provalis use commercially available controls from Aalto scientific Ltd; Glycohemoglobin controls normal and abnormal. 510(k) K952720.
- Conclusion: These performance characteristics clearly indicate substantial equivalence of the G5 I HbA1c test with the Glycosal HbA1c test and the GS II HbA1c test with the Glycosal II HbA1c test and provides a comparative accuracy to other cleared and commonly accepted methods.
8
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 graphic of three overlapping human figures, which are meant to represent people. The graphic is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." arranged in a circular fashion.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 1 6 2004
Provalis Diagnostics Ltd. c/o Mr. Thomas M. Tsakeris Devices and Diagnostics Consulting Group, Inc. 16809 Briardale Rd. Rockville, MD 20855
K041635 Re:
Trade/Device Name: G5 II HbAic Test System G5 I HbAic Test System Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: LCP, GGM Dated: June 16, 2004 Received: June 16, 2004
Dear Mr. Tsakeris:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your became in a the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated 776 the enactment date of the Medical Device Amendments, or to commerce provision to may 20, 1977, in accordance with the provisions of the Federal Food, Drug, devices that have been roomstiled in ause approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, mereleve, maneve a f the Act include requirements for annual registration, listing of general controls providive, 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 n may be babject to back and 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 r loase oc advised that i Dr bristian that your device complies with other requirements of the Act that i Dr Haral statutes and regulations administered by other Federal agencies. You must or any I catal statutes and equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice erre rart 807), tabeling the quality systems (QS) regulation (21 CFR Part 820).
9
Page 2
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Sean M. Cooper, MS, DVM.
Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
10
Indications for Use
510(k) Number (if known): K041635
Device Name: G5 II HbA1c Test System
Indications For Use: Indications for Use: The G5 II HbA1c Test System is intended for testing blood taken from a fingerprick.
G5 II HbA1c Test System shows how good glucose control has been over a two to three month period.
The G5 II HbA1c Test System consists of the HbA1c test cartridge, the G5 Instrument, the G5 System Check Cartridge and the G5 HbA1c Quality Controls.
The G5 II HbA1c Test System is intended for prescription home use.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol Benson
Division Sign-Off
Office of In Vitro Diagnost Device Evalua
Page 1 of 2
510(k) K041635
11
Indications for Use
510(k) Number (if known): K041635
Device Name: G5 | HbA1c Test System
Indications For Use: Indications for Use: The G5 I HbA1c Test System is an affinity chromatography method and is intended for the in vitro quantitative determination of HbA1c in capillary blood taken from a fingerprick or whole blood in EDTA.
G5 | HbA1c Test System is indicated for monitoring the time averaged blood glucose levels of known diabetics, for professional use as an indicator of overall Glycaemic control.
The G5 I HbA1c Test System consists of the HbA1c test cartridge, the G5 Instrument, the G5 System Check Cartridge and the G5 HbA1c Quality Controls.
The G5 I HbA1c Test System is intended for use in a physicians/ doctors office.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol Bensen
Division Sign-Off
Office of In Vitto Diagi
510(K) K041635
Page 2 of 2