(339 days)
No
The description focuses on a chemical assay and analyzer, with no mention of AI or ML terms or functionalities. The performance study is a standard correlation analysis, not indicative of AI/ML model evaluation.
No.
This device is an in vitro diagnostic assay used to measure glycated hemoglobin, which is used in the management of diabetes, but it does not directly treat or cure the disease.
Yes
The device measures glycated hemoglobin, which is used in the management of diabetes mellitus, indicating its role in providing information for diagnosing and monitoring a medical condition.
No
The device description clearly states it is an "assay" and uses an "analyzer" (Abbott IMx analyzer), which are hardware components used to perform a chemical test on a biological sample (whole blood). This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is "intended to measure glycated hemoglobin in human anticoagulated whole blood." This is a measurement performed in vitro (outside the body) on a biological sample (whole blood).
- Device Description: The description further clarifies that it's a "quantitative determination of percent glycated-hemoglobin in human anticoagulated whole blood." This reinforces the in vitro nature of the test.
- Purpose: The measurement of glycated hemoglobin is used "in the management of diabetes mellitus," which is a diagnostic and monitoring purpose.
These characteristics align directly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Abbott IMx® Glycated Hemoglobin II assay is an Ion Capture Assay intended to measure glycated hemoglobin in human anticoagulated whole blood. Measurement of glycated hemoglobin is used in the management of diabetes mellitus.
Product codes (comma separated list FDA assigned to the subject device)
LCP
Device Description
The Abbott IMx Glycated Hemoglobin II assay is a boronate affinity binding assay using Ion Capture separation for the quantitative determination of percent glycated-hemoglobin in human anticoagulated whole blood (EDTA, lithium heparin, or sodium heparin) on the Abbott IMx analyzer. Glycated hemoglobin measurements are used in the management of diabetes mellitus. The Abbott IMx Glycated Hemoglobin II assay is calibrated with Abbott IMx Glycated Hemoglobin II Calibrators. Abbott IMx Glycated Hemoglobin II Controls are assayed for the verification of the accuracy and precision of the Abbott IMx Analyzer.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A correlation study was done to compare the two assays. The results are presented in the following table:
Regression Method: Least Squares
n: 247
r: 0.976
Slope: 0.94
Intercept: 0.45
Regression Method: Passing-Bablok
n: 247
r: 0.976
Slope: 0.98
Intercept: 0.13
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
510(k) Summary
Abbott IMx ® Glycated Hemoglobin II
Submitter: Abbott Laboratories Abbott Diagnostics Division 200 Abbott Park Road Abbott Park, IL 60064 (847) 938-7707
Contact Person: Katherine M. Wortley
Date Prepared: April 26, 2000
Product Trade and Common Name: Abbott IMx ® Glycated Hemoglobin II
Classification Name: Class II, 81LCP 21 CFR 864.7470 Glycosylated Hemoglobin Assay
Predicate Device:
Bio-Rad DIAMAT™ Glycosylated Hemoglobin Analyzer System (K851636)
Description and Intended Use of the Device:
The Abbott IMx Glycated Hemoglobin II assay is a boronate affinity binding assay using Ion Capture separation for the quantitative determination of percent glycated-hemoglobin in human anticoagulated whole blood (EDTA, lithium heparin, or sodium heparin) on the Abbott IMx analyzer. Glycated hemoglobin measurements are used in the management of diabetes mellitus. The Abbott IMx Glycated Hemoglobin II assay is calibrated with Abbott IMx Glycated Hemoglobin II Calibrators. Abbott IMx Glycated Hemoglobin II Controls are assayed for the verification of the accuracy and precision of the Abbott IMx Analyzer.
Responses Page 51
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Technical Characteristics Compared to Predicate:
The technical characteristics of the two systems are presented in the table below:
| Assay Characteristics | Bio-Rad DIAMAT™
Glycosylated Hemoglobin
Analyzer System | IMx® Glycated
Hemoglobin II |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Analyte Measured: Reported | Glycated Hemoglobin: %A1c | Glycated Hemoglobin: %A1c
and %GHb |
| Assay Principle | Ion exchange liquid
chromatography (HPLC) | Boronate affinity Ion Capture |
| Instrumentation | DIAMAT Analyzer System | IMx Analyzer |
| Standardization | Traceable to the Diabetes
Control and Complications Trial
(DCCT) reference method.
Certified via the National
Glycohemoglobin
Standardization Program
(NGSP). | Traceable to the Diabetes
Control and Complications
Trial (DCCT) reference
method. Certified via the
National Glycohemoglobin
Standardization Program
(NGSP). |
| Sample Type | Human anticoagulated whole
blood (EDTA, potassium
oxalate or sodium fluoride). | Human anticoagulated whole
blood (EDTA, lithium
heparin, and sodium heparin) |
Testing to Establish Substantial Equivalence:
Substantial equivalence has been demonstrated between the IMx Glycated Hemoglobin II assay and the Bio-Rad DIAMAT Glycosylated Hemoglobin Analyzer System. The intended use for both the IMx Glycated Hemoglobin II assay and the Bio-Rad DIAMAT Glycosylated Hemoglobin Analyzer System is the quantitative determination of glycated hemoglobin in human anticoagulated whole blood. A correlation study was done to compare the two assays. The results are presented in the following table:
| Regression Method | n | r | Slope | Intercept |
|---|---|---|---|---|
| Least Squares | 247 | 0.976 | 0.94 | 0.45 |
| Passing-Bablok | 247 | 0.976 | 0.98 | 0.13 |
Conclusion:
In conclusion, these data demonstrate that the IMx Glycated Hemoglobin II is substantially equivalent to, the Bio-Rad DIAMAT Glycosylated Hemoglobin Analyzer System.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its body and wings. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font. The text is arranged around the upper half of the circle.
MAY 2 5 2000
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Katherine M. Wortley, Ph.D. Senior Regulatory Specialist ADD Regulatory Affairs Bldg. AP31, Dept. 9YC 200 Abbott Park Road Abbott Park, Illinois 60064-6200
Re: K992085 Trade Name: Abbott Imx Glycated Hemoglobin II Regulatory Class: II Product Code: LCP Dated: April 26, 2000 Received: April 27, 2000
Dear Dr. Wortley:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2
This letter will allow you to begin marketing your device as described in your 510(k) premarket I his letter will anow you to oceni marketing your device of your device to a legally marketed nothication. The PDF mainly of backantar vqur device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFF Part 801 and IT you desire specific advices your ostic devices), please contact the Office of Compliance at additionally 807.10 for mire alleghestions on the promotion and advertising of your device, (201) 594-4588. Addinonally, 18. quee at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsionals and institute and more (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Device Name: ________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Abbott IMx® Glycated Hemoglobin II assay is an Ion Capture Assay intended to measure glycated hemoglobin in human anticoagulated whole blood. Measurement of glycated hemoglobin is used in the management of diabetes mellitus.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| Prescription Use | OR | Over-The-Counter Use ______ |
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) | |
| (Division Sign-Off) | ||
| Division of Clinical Laboratory Devices | ||
| 510(k) Number | K972085 |