(190 days)
Not Found
No
The summary describes a standard immunoturbidimetric assay for HbA1c and does not mention any AI or ML components.
No.
The device is used for the quantitative determination of Hemoglobin A1c and is explicitly stated as an "in vitro quantitative determination" and an "immunoturbidimetric test," indicating a diagnostic rather than therapeutic function.
Yes
Explanation: The device is intended for the "quantitative determination of Hemoglobin A1c," which is used for "monitoring of long term blood glucose control in individuals with diabetes mellitus." This involves identifying and monitoring a physiological condition, fitting the definition of a diagnostic device.
No
The device description clearly states it is an "immunoturbidimetric test" for use on "analyzers," indicating it is a physical reagent and hardware-based system, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states "For in vitro quantitative determination Hemoglobin A1c in anticoagulated whole blood." and "For the quantitative determination of Hemoglobin A1c." The term "in vitro" is a key indicator of an IVD.
- Device Description: The description further clarifies that it is an "immunoturbidimetric test for the quantitative determination of per cent Hemoglobin A1c in anticoagulated venous or capillary whole blood". This describes a test performed on a biological sample (whole blood) outside of the body, which is the definition of an in vitro diagnostic.
- Monitoring of long term blood glucose control: While this describes the clinical application, the method of achieving this monitoring is through the in vitro measurement of HbA1c.
Therefore, based on the provided information, this device clearly falls under the category of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
For in vitro quantitative determination Hemoglobin A1c in anticoagulated whole blood.
For the quantitative determination of Hemoglobin A1c.
For monitoring of long term blood glucose control in individuals with diabetes mellitus.
Product codes (comma separated list FDA assigned to the subject device)
LCP
Device Description
The device is an immunoturbidimetric test for the quantitative determination of per cent Hemoglobin A1c in anticoagulated venous or capillary whole blood for use on the INTEGRA family of analyzers.
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)
Performance characteristics of the two devices are equivalent.
Precision:
Within-run CV
2.3% at 4.7%
2.2% at 10.3%
Total CV
2.4% at 4.7%
2.4% at 10.3%
Within-run CV
1.5% at 4.8%
1.8% at 12.1%
Total CV
2.8% at 4.8%
2.4% at 12.1%
Analytical sensitivity:
Hb: 1.5 mg/dL
HbA1c: 0.4 mg/dL
Hb: 1.5 mg/dL
HbA1c: 0.4 mg/dL
Interfering substances:
No significant interference from unconjugated bilirubin (60 mg/dL), lipemia (2000 mg/dL), or glycemia (1000 mg/dL), acetylated Hb, carbamylated Hb, and labile HbA1c.
No significant interference from icterus (25 mg/dL), lipemia (2000 mg/dL), or glycemia (1000 mg/dL), acetylated Hb, carbamylated Hb, and labile HbA1c.
Calibration stability:
Each lot and every 57 days
Each lot and every 43 days
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
SEP 3 0 1999
ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻮﺭﻳﺪ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻮﺭﻳﺪ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻮﺭﻳﺪ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻮﺭﻳﺪ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻮﺭﻳﺪ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻮﺭﻳﺪ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻮﺭﻳﺪ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻮﺭﻳﺪ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ
510(k) Summary
| 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. |
|---|---|
| Submitter | |
| name, address, | |
| contact | Roche Diagnostics Corporation |
| 9115 Hague Rd | |
| Indianapolis, IN 46250 | |
| (317) 576-3723 | |
| Contact person: Priscilla A. Hamill | |
| Date prepared: September 28, 1999 | |
| Device name | Proprietary name: INTEGRA Reagent Cassette for Hemoglobin A1c |
| Common name: Hemoglobin A1c | |
| Classification name: Glycosylated Hemoglobin Assay | |
| Predicate | |
| device | The INTEGRA Reagent Cassette for Hemoglobin A1c is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the currently marketed Roche INTEGRA Reagent Cassette for Hemoglobin A1c (K961824) |
| Device | |
| description | The device is an immunoturbidimetric test for the quantitative determination of per cent Hemoglobin A1c in anticoagulated venous or capillary whole blood for use on the INTEGRA family of analyzers. |
| Continued on next page |
1
·
| Intended use | For in vitro quantitative determination Hemoglobin A1c in anticoagulated
whole blood. |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial
equivalence --
similarities | The INTEGRA Reagent Cassette for Hemoglobin A1c is substantially
equivalent to other products in commercial distribution intended for similar
use. Most notably, it is substantially equivalent to the currently marketed
Roche INTEGRA Reagent Cassette for Hemoglobin A1c (K961824). |
| | The following table illustrates the similarities between the modified
INTEGRA Reagent Cassette for Hemoglobin A1c and the predicate device.
Draft labeling is included in Section V of this submission. Labeling for the
predicate device is provided in Section VI. |
| | Continued on next page |
2
| Feature | Modified Device (Roche
INTEGRA Cassette for
Hemoglobin A1c Whole
Blood Application) | Modified Device (Roche
INTEGRA Cassette for
Hemoglobin A1c Hemolysate
Application) |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | For the quantitative
determination of Hemoglobin
A1c. | For the quantitative
determination of Hemoglobin
A1c. |
| Indications
for use | For monitoring of long term
blood glucose control in
individuals with diabetes
mellitus. | For monitoring of long term
blood glucose control in
individuals with diabetes
mellitus. |
| Methodology | Immunoturbidimetric test
for HbA1c Colorimetric test for Total
Hb | Immunoturbidimetric test
for HbA1c Colorimetric test for Total
Hb |
| Measure-
ment
approach | Spectrophotometric | Spectrophotometric |
| Instrument
required | INTEGRA family of analyzers | INTEGRA family of analyzers |
| Measuring
range | Hb: 81-644 mg/dL HbA1c: range depends on
value of HbA1c calibrator;
a typical range is 1.3-41.9
mg/dL For a typical value of Hb
of 13.2 g/dL, the test range
for the final HbA1c(%)
results is 3-31% | Hb: 81-644 mg/dL HbA1c: range depends on
value of HbA1c calibrator;
a typical range is 1.3-41.9
mg/dL For a typical value of Hb of
13.2 g/dL, the test range for
the final HbA1c(%) results
is 3-31% |
| Sample type | Anticoagulated venous or
capillary blood | Anticoagulated venous or
capillary blood |
Continued on next page
3
Substantial equivalence -differences
The primary difference between the modified device and the predicate device is that the preparation of hemolysate is automated on the INTEGRA analyzer. Minor modifications in formulation and application parameters have also been made.
The following table illustrates the differences between the INTEGRA Reagent Cassette for Hemoglobin A1c and the predicate device.
| Feature | Modified Device (Roche
INTEGRA Cassette for
Hemoglobin A1c Whole Blood
Application) | Modified Device (Roche
INTEGRA Cassette for
Hemoglobin A1c
Hemolysate Application) |
|------------------------|----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Sample
preparation | Automated preparation of
hemolysate from anticoagulated
venous or capillary blood | Manual preparation of
hemolysate from
anticoagulated venous or
capillary blood |
| Reagent
Formulation | Modification in component
concentrations. | Latex coated with mouse
MAB for HbA1c Buffer, pH 11.5 BSA Formate Agglutinator |
| Hemolyzing
reagent | 80 mmol/L citric acid pepsin >1500 kU/L | 20 mmol/L citric acid pepsin >100kU/L |
| Wavelength | Hb - 552/659 HbA1c - 552 nm | Hb - 552/659 HbA1c - 552 nm |
Continued on next page
4
Substantial equivalence -performance characteristics Performance characteristics of the two devices are equivalent.
| Feature | Modified Device (Roche
INTEGRA Cassette for
Hemoglobin A1c Whole Blood
Application) | Modified Device (Roche
INTEGRA Cassette for
Hemoglobin A1c Hemolysate
Application) |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Precision | Within-run CV
2.3% at 4.7%
2.2% at 10.3%
Total CV
2.4% at 4.7%
2.4% at 10.3% | Within-run CV
1.5% at 4.8%
1.8% at 12.1%
Total CV
2.8% at 4.8%
2.4% at 12.1% |
| Analytical
sensitivity | Hb: 1.5 mg/dL
HbA1c: 0.4 mg/dL | Hb: 1.5 mg/dL
HbA1c: 0.4 mg/dL |
| Interfering
substances | No significant interference from
unconjugated bilirubin (60 mg/dL),
lipemia (2000 mg/dL), or glycemia
(1000 mg/dL), acetylated Hb,
carbamylated Hb, and labile
HbA1c. | No significant interference
from icterus (25 mg/dL),
lipemia (2000 mg/dL), or
glycemia (1000 mg/dL),
acetylated Hb, carbamylated
Hb, and labile HbA1c. |
| Calibration
stability | Each lot and every 57 days | Each lot and every 43 days |
5
Image /page/5/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 lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" surrounding it.
SEP 3 0 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Priscilla Hamill Laboratory Systems Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, Indiana 46250-0457
K990992 Re: Trade Name: INTEGRA Reagent Cassette for Hemoglobin A1c Regulatory Class: II Product Code: LCP Dated: July 30, 1999 Received: August 2, 1999
Dear Ms. Hamill:
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.
6
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Steven Sutman
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
7
510(k) Number (if known):
Device Name: INTEGRA Reagent Cassette for Hemoglobin Alc
Indications for Use:
For the quantitative determination of Hemoglobin A 1c in anticoagulated whole blood.
Hemoglobin A I c is indicated for the monitoring of long term blood glucose control in individuals with diabetes mellitus.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IS NEEDED) (PLEASE DO NOT WINTE BEBO # THIS LANS-----------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-the-Counter Use _
(Optional format 1-2-96)
Peter E. Martini
(Division Sign-Off)
Division of Clinical Laboratory Devices K990992
510(k) Number