(153 days)
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No
The device description details a purely enzymatic and chemical process for determining HbA1c levels. There is no mention of any computational analysis, algorithms, or learning processes that would indicate the use of AI or ML. The performance studies focus on traditional analytical metrics like precision and correlation.
No.
This device is an in vitro diagnostic (IVD) assay kit used for the quantitative determination of HbA1c to monitor long-term glucose control in individuals with diabetes, which is a diagnostic purpose, not a therapeutic one.
Yes
Explanation: The device is intended for the "in vitro quantitative determination of stable HbA1c" which is a "valuable indicator for long-term diabetic control," directly supporting a diagnosis or monitoring of diabetes.
No
The device is a clinical test kit comprised of reagents and calibrators, which are physical components used in a laboratory setting for in vitro diagnostic testing. It is not solely 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 assay is "intended for the in vitro quantitative determination of stable HbA1c... in human whole blood samples." The term "in vitro" is a key indicator of an IVD, meaning it's used outside of a living organism.
- Device Description: The description details a "clinical test kit" comprised of reagents and calibrators used to perform a test on "lyseted samples" (human whole blood). This aligns with the nature of an IVD.
- Purpose: The purpose of the test is to measure HbA1c, which is a "valuable indicator for long-term diabetic control." This indicates the device is used for diagnostic or monitoring purposes related to a medical condition.
- Predicate Device: The mention of a "Predicate Device" with a K number (K011434) is common for IVDs undergoing regulatory review (like a 510(k) submission in the US). This further supports its classification as an IVD.
N/A
Intended Use / Indications for Use
HbA1C Enzymatic Assay is intended for the in vitro quantitative determination of stable HbA1c (glycated hemoglobin A1c; A1c) in human whole blood samples. Measurement of hemoglobin A1C is a valuable indicator for long-term diabetic control.
Product codes (comma separated list FDA assigned to the subject device)
LCP, JIS; JJX
Device Description
The Diazyme's HbA1C assay kit is a clinical test kit, intended for quantitative determination of The Diazynie's TibATC assay ar is a chailed to monitor long-term glucose control in individuals with diabetes mellitus.
The Diazyme's HbA1C assay kit is comprised of a Reagent 1, Reagent 2, Lysis Buffer, THb Reagent, and calibrators.
Measurement of hemoglobin A1C is determined enzymaticly by subjecting lyseted samples to extensive protease digestion. This process releases amino acids including glycated samples to extensive process digestion: This process sines then serve as a substrate for fructosyl valines from the nemogrom octa enainer - Ery - Leaves N-terminal valines and produces valife oxidase (1' V O) chiz milen special is measured using a peroxidase catalyzed reaction nydrogen peroxiac. The fryarogen personalism is determined separately by conversion of all hemoglobin derivatives of the samples into hematin using an alkaline method as of scribed in nemogram delivatives of the samples mosterialism sed as a concentration ratio of glycated hemoglobin to total hemoglobin.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
human whole blood samples
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
Comparison analysis presented in the 510K submission for this device in the comparison section, together with linearity, precision and interference study presented demonstrated that the Diazyme's HBAIC Enzymatic Assay has excellent accuray and is safe and effective. There is no significant deviation between the results obtained by Diazyme's and enective. There is no significant actively come testing clinical patient samples.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
| 5.3% Alc | 12% Alc | |
|---|---|---|
| Intra-Assay Precision | CV%= 3.5% | CV%= 1.6% |
| Inter-Assay Precision | CV%= 5.0% | CV%= 7.2% |
Correlation coefficient of 0.92 with Tosoh's.
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.
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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).
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§ 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
Diazyme Laboratories Division, General Atomics
Image /page/0/Picture/2 description: The image shows the word "DIAZYME" in bold, block letters. Above the word is a symbol that resembles a four-pointed star or a stylized flower. The symbol is centered above the word, creating a logo-like appearance. The overall impression is of a company logo or brand name.
JUN 2 8 2005
Summary
Submitter's name:
Submitter's address:
Phone: Fax:
Name of Contact Person:
Huan Tran Diazyme Laboratories Division General Atomics 3550 General Atomics Court San Diego, CA 92121 Phone: 858-455-4761 Fax: 858-455-4750
3550 General Atomics Court
San Diego, CA 92121
858-455-4754
858-455-4750
Date the summary was prepared:
December 25, 2004
HbA1C Enzymatic Assay Name of the device: HbA1C Enzymatic Assay Trade Name: Enzymatic Assay, HbA1C Common/Usual Name: Glycosylated Hemoglobin Assay (Per 21CFR section 864.7470) Classification Name: Device Class: II
Predicate Device:
The legally marketed device to which we are claiming equivalence [807.92(4)(3)]: G7 I he regally marketed device to willon we are canning of I
Automated HPLC Analyzer: HbA1c Variant Analysis Mode (K011434) manufactured by Tosoh Medics, Inc., San Francisco, CA, 94080.
Description of the device
The Diazyme's HbA1C assay kit is a clinical test kit, intended for quantitative determination of The Diazynie's TibATC assay ar is a chailed to monitor long-term glucose control in individuals with diabetes mellitus.
The Diazyme's HbA1C assay kit is comprised of a Reagent 1, Reagent 2, Lysis Buffer, THb Reagent, and calibrators.
Measurement of hemoglobin A1C is determined enzymaticly by subjecting lyseted samples to extensive protease digestion. This process releases amino acids including glycated samples to extensive process digestion: This process sines then serve as a substrate for fructosyl valines from the nemogrom octa enainer - Ery - Leaves N-terminal valines and produces valife oxidase (1' V O) chiz milen special is measured using a peroxidase catalyzed reaction nydrogen peroxiac. The fryarogen personalism is determined separately by conversion of all
1
hemoglobin derivatives of the samples into hematin using an alkaline method as of scribed in nemogram delivatives of the samples mosterialism sed as a concentration ratio of glycated hemoglobin to total hemoglobin.
Intended Use of the Device:
HbA1C Enzymatic Assay is intended for the in vitro quantitative determination of stable HbA1C (glycated hemoglobin A1c; A1c) in human whole blood samples. Measurement of hemoglobin A1C is a valuable indicator for long-term diabetic control.
HbAIC Enzymatic Assay Kit contains an A1C calibrator and a THb calibrator. The calibrators HDATC Entzymanc Assay for the quantitative determination of HbA1C in blood.
HbAIC Enzymatic Assay has controls design to be used with the assay for the quantitative determination of HbA1C in blood.
Performance Characteristics
Diazyme's HbA1C Enzymatic Assay is a two reagents based kinetic assay system. The assay offers excellent precision as shown in the table below:
| 5.3% Alc | 12% Alc | |
|---|---|---|
| Intra-Assay Precision | CV%= 3.5% | CV%= 1.6% |
| Inter-Assay Precision | CV%= 5.0% | CV%= 7.2% |
Diazyme's HbA1C Enzymatic Assay has a good correlation with Tosoh's with arthershap Diazyine S TIOATC Litzynatic Tissay has a good - See a good by spiking the substances correlation coefinelen of 0.22. We have connected at the indicated concentrations:
| Interference | Concentration |
|---|---|
| Triglyceride | 2000 mg/dl |
| Bilirubin | 10 mg/dl |
| Ascorbic Acid | 4 mg/dl |
| Uric Acid | 5 mg/dl |
| Glucose | 2400 mg/dl |
Conclusion: Comparison analysis presented in the 510K submission for this device in the comparison section, together with linearity, precision and interference study presented demonstrated that the Diazyme's HBAIC Enzymatic Assay has excellent accuray and is safe and effective. There is no significant deviation between the results obtained by Diazyme's and enective. There is no significant actively come testing clinical patient samples.
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Therefore, Diazyme's HbA1C Enzymatic Assay is substantially similar to the commercially Therefore, Diazyme's HDATC Entzymane Assay is Sabstannally Ships of Same Shole blood samples.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
JUN 2 8 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Huan Tran Quality Assurance Manager Diazyme Laboratories Division General Atomics 3550 General Atomics Court San Diego, CA 92121
K050178 Re:
Trade/Device Name: HbA1C Enzymatic Assay Kit Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: LCP, JIS; JJX Dated: June 1, 2005 Received: June 3, 2005
Dear Mr. Tran:
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).
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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 (240) 276-0484. 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/industry/support/index.html.
Sincerely yours,
Carol C. Benam
Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K050178
Device Name: HbA1C Enzymatic Assay Kit
Indications for Use:
HbA1C Enzymatic Assay is intended for the in vitro quantitative determination of stable HbA1C Enzymatic Assay is intented for the in human whole blood samples. Measurement
HbA1c (glycated hemoglobin A1c; A1c) in human whole blootis control HDATC (glycated nemogrobin ATC, ATC) in management diabetic control.
of hemoglobin A1C is a valuable indicator for long-term diabetic control.
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)
Keeleff
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
210(k)_KOSO178