(68 days)
Not Found
No
The summary describes a reagent kit for a chemistry analyzer and does not mention any AI or ML components. The performance studies are standard analytical chemistry evaluations.
No.
This device is an in vitro diagnostic reagent kit used for measuring hemoglobin A1c, which is a diagnostic tool for monitoring diabetes, not a device that provides therapy or treatment.
Yes
The text states that the "Determination of hemoglobin A1c provides an important diagnostic tool for monitoring the efficiency of dietary control and therapy during treatment of diabetes mellitus."
No
The device description clearly states it is a "reagent kit" containing cartridges 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 explicitly states it's for the "quantitative determination of hemoglobin A1c (HbA1c2) concentration as a percentage of total hemoglobin in human whole blood." This involves testing a biological sample (whole blood) outside of the body to provide information about a patient's health status (long-term glucose control in patients with diabetes mellitus).
- Device Description: The device is a "reagent kit" designed for use with a "SYNCHRON LX® System(s)." Reagents are substances used in chemical reactions, and systems like the SYNCHRON LX are laboratory instruments used for analyzing biological samples.
- Performance Studies: The performance studies describe testing the reagent kit with human samples ("Normal Sample," "Abnormal Sample") and comparing the results to other methods used for HbA1c measurement.
All of these characteristics 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 diagnostic purposes.
N/A
Intended Use / Indications for Use
The Hemoglobin A1c2 (HbA1c2) reagent kit, when used in conjunction with SYNCHRON LX® System(s) and SYNCHRON® Systems HbA1c2 Calibrators, is intended for the quantitative determination of hemoglobin A1c (HbA1c2) concentration as a percentage of total hemoglobin in human whole blood.
Measurement of hemoglobin A1c is accepted as a method to measure long-term glucose control in patients with diabetes mellitus (a chronic disorder associated with disturbances in carbohydrate, fat, and protein metabolism and characterized by hyperglycemia). Determination of hemoglobin A1c provides an important diagnostic tool for monitoring the efficiency of dietary control and therapy during treatment of diabetes mellitus.
Product codes (comma separated list FDA assigned to the subject device)
LCP
Device Description
The SYNCHRON LX® System(s) HbA1c2 reagent is designed for optimal performance on the SYNCHRON LX® System(s). The reagent kit contains two A1c2 80-test cartridges, one Hb2 160-test cartridge and one 2 mL bottle each of Hb/A1c2 Calibrator Level 2, A1c2 Calibrator Levels 3, 4 and 5.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison, stability, linearity, and imprecision experiments.
Method Comparison Study Results:
Instrument: SYNCHRON LX; Slope: 0.911; Intercept: 0.46; r: 0.991; n: 80; Comparison Method: SYNCHRON HbA1c
Instrument: SYNCHRON LX; Slope: 1.042; Intercept: -0.56; r: 0.994; n: 80; Comparison Method: Tosoh A1c
SYNCHRON LX System HbA1c2 Reagent Imprecision Results:
Within-Run Imprecision
Sample: Normal; Mean (%): 5.5; S.D. (%): 0.07; %C.V.: 1.2; N: 80
Sample: Abnormal; Mean (%): 9.8; S.D. (%): 0.09; %C.V.: 1.0; N: 80
Total Imprecision
Sample: Normal; Mean (%): 5.5; S.D. (%): 0.14; %C.V.: 2.6; N: 80
Sample: Abnormal; Mean (%): 9.8; S.D. (%): 0.27; %C.V.: 2.8; N: 80
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.
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
NOV 17 2004
510(k) Summary SYNCHRON LX® Systems Hemoglobin A1c2 (HbA1c2) Reagent
1.0 Submitted By:
Kim Walker Regulatory Affairs Manager Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 Brea, California 92822-8000 Telephone: (714) 961-4912 FAX: (714) 961-4123
2.0 Date Submitted:
September 8, 2004
3.0 Device Name(s):
3.1 Proprietary Names
SYNCHRON LX® Systems Hemoglobin A1c2 (HbA1c2) Reagent
3.2 Classification Name
Glycosylated hemoglobin assay (21 CFR § 864.7470)
4.0 Predicate Device:
| Candidate | Predicate | Manufacturer | Docket
Number |
|------------------------------------------|--------------------------------------|--------------------------|------------------|
| SYNCHRON LX
Systems
HbA1c2 Reagent | SYNCHRON
Systems
HbA1c Reagent | Beckman
Coulter, Inc. | K010748 |
5.0 Description:
The SYNCHRON LX® System(s) HbA1c2 reagent is designed for optimal performance on the SYNCHRON LX® System(s). The reagent kit contains two A1c2 80-test cartridges, one Hb2 160-test cartridge and one
1
2 mL bottle each of Hb/A1c2 Calibrator Level 2, A1c2 Calibrator Levels 3, 4 and 5.
6.0 Intended Use:
The Hemoglobin A1c2 (HbA1c2) reagent kit, when used in conjunction with SYNCHRON LX® System(s) and SYNCHRON® Systems HbA1c2 Calibrators, is intended for the quantitative determination of hemoglobin A1c (HbA1c2) concentration as a percentage of total hemoglobin in human whole blood.
7.0 Comparison to Predicate(s):
The following tables show similarities and differences between the predicate identified in Section 4.0 of this summary.
| Reagent | Aspect/Characteristic | Comments |
|---|---|---|
| HbA1c2 | Intended Use | Same as Beckman |
| Reagent | Liquid Stable Reagent | SYNCHRON HbA1c |
| Reagent | ||
| Analytical Range | ||
| Sample Type | ||
| Reference Intervals | ||
| Shelf Life Stability | ||
| Anticoagulants Used | ||
| Storage Temperature (+2°C to +8°C) | ||
| Interferences | ||
| Specificity | ||
| Sensitivity | ||
| Sample Size | ||
| Methodology | ||
| Formulation | ||
| Calibration |
Similarities to the Predicate
2
| Reagent | Aspect/
Characteristic | Comments |
|-------------------|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| HbA1c2
Reagent | Sample Preparation | HbA1c2 does not require any sample
preparation whereas HbA1c requires manual
(off-line) sample preparation; the system
automatically prepares the sample (on-line).
However, HbA1c2 can be prepared off-line as
well. |
| | Limitations | Additional limitations have been added to the
HBA1c2 assay that relate to Erythrocyte
Sedimentation Rate and proper mixing of whole
blood. |
| | Reactive
Ingredients | HbA1c2 contains Hemolyzing Reagent in the
reagent cartridge itself whereas HbA1c reagent
required a customer to hemolyze a sample off-
line with separately purchased Hemolyzing
Reagent. |
Differences From The Predicate
8.0 Summary of Performance Data:
.
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison, stability, linearity, and imprecision experiments.
Method Comparison Study Results
| Instrument | Slope | Intercept | r | n | Comparison Method |
|---|---|---|---|---|---|
| SYNCHRON LX | 0.911 | 0.46 | 0.991 | 80 | SYNCHRON HbA1c |
| SYNCHRON LX | 1.042 | -0.56 | 0.994 | 80 | Tosoh A1c |
3
| Sample | Mean
(%) | S.D.
(%) | %C.V. | N |
|------------------------|-------------|-------------|-------|----|
| Within-Run Imprecision | | | | |
| Normal | 5.5 | 0.07 | 1.2 | 80 |
| Abnormal | 9.8 | 0.09 | 1.0 | 80 |
| Total Imprecision | | | | |
| Normal | 5.5 | 0.14 | 2.6 | 80 |
| Abnormal | 9.8 | 0.27 | 2.8 | 80 |
SYNCHRON LX System HbA1c2 Reagent Imprecision Results
This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image is a circular seal with the logo of the U.S. Department of Health and Human Services. The seal features the department's emblem, which is a stylized caduceus with three snakes intertwined around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper half of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 1 7 2004
Ms. Kim Walker Regulatory Affairs Manager Beckman Coulter, Inc. 200 S. Kraemer Boulevard P.O. Box 8000 Brea, CA 92822-8000
Re: K042459
Trade/Device Name: SYNCHRON LX® Systems Hemoglobin A1c2 (HbA1c2) Reagent Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: LCP Dated: September 8, 2004 Received: September 10, 2004
Dear Ms. Walker:
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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
5
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,
Sincerely, yours,
Cornelia B. Parks
Cornelia B. Rooks, MA Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K042459
SYNCHRON LX® Systems Hemoglobin A1c2 (HbA1c2) Device Name: Reagent
Indications for Use:
The Hemoglobin A1c2 (HbA1c2) reagent kit, when used in conjunction with SYNCHRON LX® System(s) and SYNCHRON® Systems HbA1c2 Calibrators, is intended for the quantitative determination of hemoglobin A1c (HbA1c2) concentration as a percentage of total hemoglobin in human whole blood.
Measurement of hemoglobin A1c is accepted as a method to measure long-term glucose control in patients with diabetes mellitus (a chronic disorder associated with disturbances in carbohydrate, fat, and protein metabolism and characterized by hyperglycemia). Determination of hemoglobin A1c provides an important diagnostic tool for monitoring the efficiency of dietary control and therapy during treatment of diabetes mellitus.
Prescription Use X (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)
Division Sign-Off
Division Sign-Off
Page 1 of ﻠﺴ
Office of In Vitro Diagnostic Device Evaluation and Safety
510k K042459
Beckman Coulter, Inc., Section 510(k) Notification SYNCHRON LX® Systems Hemoglobin A1c2 (HbA1c2) Reagent K042459 Revised Indications for Use, September 2004