(49 days)
Not Found
No
The summary describes a standard immunoturbidimetric assay for a specific analyte, with no mention of AI or ML in the intended use, device description, or performance studies. The predicate device is also a traditional reagent cassette.
No
The device is an in vitro diagnostic test for the quantitative determination of Apolipoprotein B, used for diagnosis and treatment monitoring, not for direct therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Apolipoprotein B measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases." This indicates a diagnostic purpose.
No
The device description clearly states it is an "immunoturbidimetric test" for use on "analyzers," indicating it is a physical reagent and likely involves hardware components for analysis, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "For in vitro quantitative determination of Apolipoprotein B in serum and plasma." This clearly indicates that the device is used to test samples taken from the human body outside of the body (in vitro).
- Device Description: The description confirms it's an "immunoturbidimetric test for the quantitative determination of Apolipoprotein B in serum and plasma." This further reinforces its use in analyzing biological samples.
- Purpose: The intended use also states that the measurements are used in the "diagnosis and treatment of lipid disorders... atherosclerosis, and various liver and renal diseases." This aligns with the purpose of IVDs, which are used to provide information for diagnostic or therapeutic purposes.
The information provided strongly supports the classification of this device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
For in vitro quantitative determination of Apolipoprotein B in serum and plasma. Apolipoprotein B measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
Product codes
DFC
Device Description
The device is an immunoturbidimetric test for the quantitative determination of Apolipoprotein B in serum and plasma 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, including precision, analytical sensitivity, calibration interval, and limitations statements for the two devices are equivalent.
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
§ 866.5600 Low-density lipoprotein immunological test system.
(a)
Identification. A low-density lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify young persons at risk from cardiovascular diseases.(b)
Classification. Class II (performance standards).
0
APR 1 4 1959
ﻧﻌﻤﺎﻟﻪ ﻣﻦ ﻣﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤ
。 ・
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: February 23, 1999 |
| Device name | Proprietary name: INTEGRA Reagent Cassette for Apolipoprotein B
Common name: Apolipoprotein B
Classification name: Lipoprotein Test System |
| Predicate device | We claim substantial equivalence to the currently marketed Roche INTEGRA Reagent Cassette for Apolipoprotein B. |
| Device description | The device is an immunoturbidimetric test for the quantitative determination of Apolipoprotein B in serum and plasma for use on the INTEGRA family of analyzers. |
1
12990595
510(k) Summary, Continued
。 六
| Intended use | For in vitro quantitative determination of Apolipoprotein B in serum and plasma |
|---|---|
| Substantial equivalence – similarities | The INTEGRA Reagent Cassette for Apolipoprotein B 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 Apolipoprotein B (K951595) |
| The following table illustrates the similarities between the modified INTEGRA Reagent Cassette for Apolipoprotein B and the predicate device. Specific data on the performance of the test have been incorporated into the draft labeling in Section V of this submission. Labeling for the predicate device is provided in Section VI. |
.
Continued on next page
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2
510(k) Summary, Continued
.. ಸೆ
| Feature | Modified Device | Predicate Device | |
|---|---|---|---|
| Intended use | For the quantitative | ||
| determination of | |||
| Apolipoprotein B. | For the quantitative | ||
| determination of | |||
| Apolipoprotein B. | |||
| Indications | |||
| for use | Apolipoprotein B | ||
| measurements are used in the | |||
| diagnosis and treatment of | |||
| lipid disorders (such as | |||
| diabetes mellitus), | |||
| atherosclerosis, and various | |||
| liver and renal diseases. | Apolipoprotein B | ||
| measurements are used in the | |||
| diagnosis and treatment of lipid | |||
| disorders (such as diabetes | |||
| mellitus), atherosclerosis, and | |||
| various liver and renal diseases. | |||
| Methodology | Immunoturbidimetric | Immunoturbidimetric | |
| Measure- | |||
| ment | |||
| approach | Spectrophotometric | Spectrophotometric | |
| Instrument | |||
| required | INTEGRA family of analyzers | INTEGRA family of analyzers | |
| Measuring | |||
| range | 0.26-3.9 g/L | ||
| 0.09-7.8 g/L with rerun | 0.26-3.9 g/L | ||
| 0.09-7.8 g/L with rerun | |||
| Formulation | Anti-apolipoprotein B T | ||
| antiserum (sheep) specific for | |||
| human apolipoprotein B in | |||
| phosphate buffer stabilized | |||
| with 0.09% sodium azide. | Anti-apolipoprotein B T | ||
| antiserum (sheep) specific for | |||
| human apolipoprotein B in | |||
| phosphate buffer stabilized | |||
| with 0.09% sodium azide. | |||
| Substantial | |||
| equivalence - | |||
| differences | The modified device differs from the predicate device in that plasma is now | ||
| claimed as an acceptable specimen type. | |||
| The following table illustrates the differences between the INTEGRA Reagent | |||
| Cassette for Apolipoprotein B and the predicate device. | |||
| Feature | Modified Device | Predicate Device | |
| Sample type | Serum and plasma | Serum | |
| Substantial | |||
| equivalence - | |||
| performance | |||
| characteristics | Performance characteristics, including precision, analytical sensitivity, | ||
| calibration interval, and limitations statements for the two devices are | |||
| equivalent. |
3
Public Health Service
Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are designed to resemble a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
APR 1 4 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Priscilla A. Hamill Regulatory Affairs Consultant Roche Diagnostics Corporation 9115 Hague Road Indianapolis, Indiana 46250-0457
Re: K990595 Trade Name: INTEGRA Reagent Cassette for Apolipoprotein B : Regulatory Class: II Product Code: DFC Dated: February 23, 1999 Received: February 24, 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 OS 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.
4
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 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
5
S10(k) Number (if known): ___
K 990593
Device Name: INTEGRA Reagent Cassette for Apolipoprotein B
Indications for Üse:
For the quantitative determination of apolipoprotein B in serum and plasma.
A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders and atherosclerosis.
Sean Coogan
(Division Sign-Off)
Division of Clinical Laboratory Devices Knights Hyly 510(k) Number _
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IS NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------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)