(448 days)
Not Found
No
The description focuses on the chemical reagents and calibrators used in a standard in vitro diagnostic assay for HbA1c, with no mention of AI or ML technologies.
No.
This device is an in vitro diagnostic (IVD) test for quantitative determination of HbA1c, used for monitoring blood glucose control in diabetic patients, not for treating any condition.
Yes
The device is intended for the quantitative in vitro diagnostic determination of hemoglobin A1c (HbA1c) in human whole blood, which is used for monitoring long term blood glucose control in diabetic patients. This clearly indicates its use in diagnosing and monitoring a medical condition.
No
The device description explicitly states it consists of reagents and calibrators, which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the ELITech Clinical Systems HbA1c is intended for "quantitative in vitro diagnostic determination of hemoglobin A1c (HbA1c) in human whole blood". It also mentions the calibrator and control sets are for "in vitro diagnostic use".
- Device Description: The description details reagents, calibrators, and controls used to perform a test on a biological sample (human whole blood) outside of the body.
- Anatomical Site: The test is performed on "human whole blood", which is a biological sample.
All of these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
N/A
Intended Use / Indications for Use
ELITech Clinical Systems HbA1c is intended for use in the quantitative in vitro diagnostic determination of hemoglobin A1c (HbA1c) in human whole blood on Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings.
HbA1c measurements are used for the monitoring of long term blood glucose control in diabetic patients.
ELITech Clinical Systems HbA1c CALIBRATOR SET is a calibrator with 4 different levels of values for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems HbA1c on Vital Scientific Selectra/Flexor analyzers as specified in the instructions for use.
ELITech Clinical Systems HbA1c CONTROL L+ H is a quality control with 2 levels of values (Low and High values) for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems HbA1c on Vital Scientific Selectra/Flexor analyzers as specified in the instructions for use.
Product codes (comma separated list FDA assigned to the subject device)
LCP, JIT, JJX
Device Description
The device for this submission is available as a kit only. It consists of 3 reagents. Reagent R1 contains suspended latex particles in a buffer with stabilizers and sodium azide. Reagent R2a and Reagent R2b are mixed to prepare a working reagent, Reagent 2. This mixture contains Mouse anti-human HbA1c monoclonal antibody and Goat anti-mouse IgG polyclonal antibody in a buffer containing stabilizers and sodium azide. Reagent R3, a hemolysis reagent, is an aqueous solution containing sodium azide.
The device for this submission is available as kit only. It consists of 4 different levels of calibrator at 0.5 mL volume. Each level consists of lyophilized hemolysates prepared from human erythrocytes. HbA1c CALIBRATOR SET is prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HI according to FDA-approved methods.
ELITech Clinical Systems HbA1c Control L + H is a two level quality control product consisting of lyophilized hemolysates prepared from human erythrocytes containing constituents at desired levels. HbA1c CONTROL L+ H is prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Human whole blood
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not intended for use in Point of Care 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)
Comparison to Predicate device:
Method comparison: y=0.926x + 0.1 %, r= 0.984
Precision:
Within run: Level 4.4 % CV= 1.1 %, Level 6.7 % CV= 0.9 %, Level 9.5 % CV= 1.0 %
Total: Level 4.4 % CV= 2.3 %, Level 6.7 % CV= 1.9 %, Level 9.5 % CV= 2.9 %
Limitations: No significant interference for unconjugated bilirubin (up to 30 mg/dL), conjugated bilirubin (up to 29.5 mg/dL), triglycerides (up to 2000 mg/dL), Acetylsalicylic acid (up to 200 mg/dL), Rhumatoid factor (up to 1000 IU/mL), Ascorbic acid (up to 20 mg/dL). Interference due to Vitamin E has not been assessed. Hemoglobin variants: HbC, HbS, HbD, HbE and HbA2: No significant interference. High concentration of HbF lead to a underestimation of HbA1c. Chemically modified Hemoglobin: Carbamylated hemoglobin: No significant interference up to 10 mmol/L of added sodium cyanate. Acetylated hemoglobin: No significant interference up to 10 mmol/L of added aspirin. Labile HbA1c: No significant interference up to 1000 mg/dL of added glucose. It has been reported that results may be unreliable with patients who suffer from alcoholism (formation of acetaldehyde hemoglobin).
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.
Hemoglobin A1c Reagent Set (K031539)
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
§ 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
Section 5 : 510(k) Summary
MAY 19 2011
According to the requirements of 21 CFR 807.92, the following information Introduction provides sufficient detail to understand the basis for a determination of substantial equivalence.
The assigned 510(k) number is : K100547
| Submitter | SEPPIM S.A.S. |
|---|---|
| Address | Zone Industrielle, 61500 SEES, FRANCE |
| Phone number | + 33 (0)2 33 81 21 00 |
| Fax number | + 33 (0)2 33 28 77 51 |
| Contact | Valérie GOURDON (Email: v.gourdon@elitechgroup.com) |
| Date of Preparation | February 8th, 2010 |
Device names
| REAGENT : | |
|---|---|
| Trade/proprietary Name: | ELITech Clinical Systems HbA1c |
| Common or Usual Name: | Glycosylated Hemoglobin "HbA1c" |
| Device Class | Class II |
| Classification name | Assay, Glycosylated Hemoglobin (Sec.864.7470) |
| Product code | LCP; Assay, Glycosylated Hemoglobin |
| Predicate device | Hemoglobin A1c Reagent Set (K031539) |
|---|---|
| ------------------ | -------------------------------------- |
| Device description | The device for this submission is available as a kit only. It consists of 3 reagents. Reagent R1 contains suspended latex particles in a buffer with stabilizers and sodium azide. Reagent R2a and Reagent R2b are mixed to prepare a working reagent, Reagent 2. This mixture contains Mouse anti-human HbA1c monoclonal antibody and Goat anti-mouse IgG polyclonal antibody in a buffer containing stabilizers and sodium azide. Reagent R3, a hemolysis reagent, is an aqueous solution containing sodium azide. |
|---|---|
| -------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Intended Use | ELITech Clinical Systems HbA1c is intended for use in the quantitative in vitro diagnostic determination of hemoglobin A1c (HbA1c) in human whole blood on Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings. |
|---|---|
| -------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Indication for use | HbA1c measurements are used for the monitoring of long term blood glucose control in diabetic patients. |
|---|---|
| -------------------- | --------------------------------------------------------------------------------------------------------- |
1
Comparison to Predicate device
| ELITech Clinical Systems | Predicate device | ||
|---|---|---|---|
| Device (HbA1c) | (Pointe Scientific Hemoglobin | ||
| A1c Reagent Set) | |||
| Intended use | ELITech Clinical Systems | ||
| HbA1c is intended for use in the | |||
| quantitative in vitro diagnostic | |||
| determination of hemoglobin | |||
| A1c (HbA1c) in human whole | |||
| blood on Vital Scientific | |||
| Selectra/Flexor analyzers. It is | |||
| not intended for use in Point of | |||
| Care settings. | For the quantitative determination | ||
| of hemoglobin A1c (HbA1c) in | |||
| human blood. For in vitro | |||
| diagnostic use only. | |||
| Indication for Use | HbA1c measurements are used | ||
| for the monitoring of long term | |||
| blood glucose control in diabetic | |||
| patients. | The determination of hemoglobin | ||
| A1c is most commonly performed | |||
| for the evaluation of glycemic | |||
| control in diabetes. Hemoglobin | |||
| A1c values provide an indication | |||
| of glucose levels over the | |||
| preceding 4-8 weeks. A higher | |||
| hemoglobin A1c value indicates | |||
| poorer glycemic control. | |||
| Assay protocol | Immuno-turbidimetry enhanced | ||
| by latex particles using a two- | |||
| reagent reaction sequence. | Same. | ||
| Composition | Reagent R1 : | ||
| Suspended latex particles 0.13%; | |||
| Buffer, stabilizers ; sodium azide in vitro diagnostic use in the calibration of quantitative ELITec | |||
| Clinical Systems HbA1c on Vital Scientific Selectra/Flexor analyzers as specified i |
5
Comparison to Predicate device
| | ELITech Clinical Systems Device
(HbA1c CALIBRATOR SET) | Predicate Device
(Pointe Scientific Hemoglobin A1c Calibrator Set) |
|--------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | ELITech Clinical Systems HbA1c CALIBRATOR SET is a calibrator with 4 different levels of values for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems HbA1c on Vital Scientific Selectra/Flexor analyzers as specified in the instructions for use. | For the purpose of calibrating results in the quantitative determination of human hemoglobin A1c (HbA1c) in blood by automated immunoassay. For in vitro diagnostic use only. |
| Format | Lyophilized hemolysates from human erythrocytes. | Hemolysate prepared from packed human erythrocytes. |
| Levels | Four (4) levels | Four (4) levels |
| Handling | Reconstitute each calibrator using 0.5 mL of deionized water. Gently mix for 10 minutes or until all material has dissolved. Each Control should be hemolysis before use | Same |
| Stability | Prior to reconstitution : To store at 2-8 °C and protected from light until the expiry date
After reconstitution : Calibrators are stable 30 days when stored at 2-8 °C - After opening, the vials should be kept correctly and tightly capped to prevent contamination and evaporation | Same |
Conclusion The performance data and other information conclude that the safety and effectiveness of the device is not compromised, and that it met all acceptance criteria, demonstrating that the device is substantially equivalent to his respective predicate device:
6
.
| Device names | |
|---|---|
| CONTROLS: | |
| Trade/proprietary Name: | |
| Common or Usual Name: | ELITech Clinical Systems HbA1c CONTROL L + H |
| Single (Specified) analyte control, Assayed, "HbA1c CONTROL L + H" | |
| Device Class | Class I |
| Classification name | Quality control material (assayed and unassayed). (Sec.862.1660) |
| Product code | JJX- Single (specified) analyte controls (assayed and unassayed) |
| Predicate device | Hemoglobin A1c Control Set (K031539) |
| Device description | ELITech Clinical Systems HbA1c Control L + H is a two level quality control products |
| consisting of lyophilized hemolysates prepared from human erythrocytes containing | |
| constituents at desired levels. | |
| HbA1c CONTROL L+ H is prepared exclusively from the blood of donors tested | |
| individually and found to be negative for HbsAg and to antibodies to HCV and HIV | |
| according to FDA-approved methods. |
- ELITech Clinical Systems HbA1c CONTROL L+ H is a quality control with 2 levels of Intended Use values (Low and High values) for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems HbA1c on Vital Scientific Selectra/Flexor analyzers as specified in the instructions for use.
Comparison to Predicate device
| | ELITech Clinical Systems Device
(HbA1c CONTROL L+H) | Predicate Device
(Pointe Scientific Hemoglobin A1c
Control Set) |
|--------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | ELITech Clinical Systems HbA1c
CONTROL L+ H is a quality control with 2
levels of values (Low and High values) for
in vitro diagnostic use in accuracy control
of quantitative ELITech Clinical Systems
HbA1c on Vital Scientific Selectra/Flexor | For the purpose of monitoring
accuracy and precision in the
quantitative determination of human
hemoglobin A1c (HbA1c) in blood
by automated immunoassay. For in
vitro diagnostic use only. |
7
| | ELITech Clinical Systems Device
(HbA1c CONTROL L+H ) | Predicate Device
(Pointe Scientific Hemoglobin A1c
Control Set) |
|-----------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| | analyzers as specified in the instructions
for use. | |
| Format | Lyophilized hemolysates from human
erythrocytes. | Hemolysate prepared from packed
human erythrocytes. |
| Levels | Two (2) levels | Two (2) levels |
| Handling | Reconstitute each control using 0.5 mL of
deionized water, Gently mix for 10
minutes or until all material has dissolved.
Each Control should be hemolysis before
use | Same |
| Stability | Prior to reconstitution : To store at 2-8 °C
and protected from light until the expiry
date | Same |
| | After reconstitution : Controls are stable
30 days when stored at 2-8 °C
- After opening, the vials should be kept
correctly and tightly capped to prevent
contamination and evaporation | |
Conclusion The performance data and other information conclude that the safety and effectiveness of the device is not compromised, and that it met all acceptance criteria, demonstrating that the device is substantially equivalent to his respective predicate device.
8
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/8/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the upper half of the circle.
SEPPIM S.A.S c/o Debra Hutson ELITechGroup Epoch Biosciences 21720 23rd Dr. SE. Suite 150 Bothell, Washington 98021
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Image /page/8/Picture/5 description: The image shows the date May 19, 2011. The month is written in all caps. The day is written as a single digit. The year is written as four digits.
Re: K100547
Trade Name: ELITech Clinical Systems HbA1c Reagent, ELITech Clinical Systems HbA1c Calibrator Set, ELITech Clinical Systems HbA1c Control L+H Regulation Number: 21CFR 864.7470 Regulation Name: Glycosylated Hemoglobin Assay Regulatory Class: Class II Product Codes: LCP, JIT, JJX Dated: April 18, 2011 Received: April 19, 2011
Dear Ms Hutson:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
9
Page 2 -
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office - of-Surveillance and-Biometrics/Division-of-Postmarket-Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
G.C.
Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
10
Indications for Use Form
510(k) Number (if known): K100547
Device Name: ELITech Clinical Systems HbA1c
Indications for Use:
ELITech Clinical Systems HbA1c is intended for use in the quantitative in vitro diagnostic determination of hemoglobin A1c (HbA1c) in human whole blood on Vital Scientific SelectralFlexor analyzers.It is not intended for use in Point of Care settings.
HbA1c measurements are used for the monitoring of long term blood glucose control in diabetic patients.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K100547
Page 1 of 3
11
Indications for Use Form
510(k) Number (if known): j/100547
Device Name: ELITech Clinical Systems HbA1c calibrator set
Indications for Use:
ELITech Clinical Systems HbA1c Calibrator set is a calibrator with 4 different levels of values for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems HbA1c on Vital Scientific Selectra/Flexor analyzers as specified in the instructions for use.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K10054
Page 2 of 3
12
Indications for Use Form
510(k) Number (if known): K100547
Device Name: ELITech Clinical Systems HbA1c Control L+ H
Indications for Use:
ELITech Clinical Systems HbA1c Control L+H is a quality control with.2 levels of values (Low and High values) for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems HbA1c on Vital Scientific SelectralFlexor analyzers as specified in the instructions for use.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) `1