(18 days)
Not Found
No
The description details a chemical assay based on enzymatic reactions and absorbance measurements, with no mention of AI or ML technologies.
No.
This device is an in vitro diagnostic reagent system used for the quantitative determination of LDL-Cholesterol, which aids in diagnosis and treatment monitoring, but it does not directly treat a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "an in vitro diagnostic reagent system" and that "Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases."
No
The device description clearly states it is an "in vitro diagnostic reagent system" and describes a chemical reaction and measurement of absorbance, indicating it is a physical reagent kit, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states the device is an "in vitro diagnostic reagent system" and is "intended for use on COBAS Integra systems for the quantitative determination of LDL-Cholesterol concentration in serum and plasma." It also describes how these measurements are used in the "diagnosis and treatment of lipid disorders."
- Device Description: The description details a chemical reaction that occurs in vitro (outside the body) to measure a substance in a biological sample (serum and plasma).
- Predicate Device: The mention of a predicate device (K974733; Roche/Hitachi LDL-Cholesterol plus 2nd generation assay) which is also an IVD further supports this classification.
The core function of the device is to analyze a biological sample in vitro to provide information for diagnostic purposes, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The cassette COBAS Integra LDL-Cholesterol plus 2nd Generation contains an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of LDL-Cholesterol concentration 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 (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
Product codes (comma separated list FDA assigned to the subject device)
MRR
Device Description
The LDL-Cholesterol plus 2nd Generation test principle is based on the selective micellary solubilization of LDL-cholesterol by a nonionic detergent and the interaction of a sugar compound and lipoproteins. The inclusion of a sugar compound and a detergent in the enzymatic method for cholesterol determination (cholesterol esterase cholesterol oxidase coupling reaction) enables the selective determination of LDL-cholesterol. The color intensity of the blue quinoneimine dye formed is directly proportional to the LDL- Cholesterol concentration. It is determined by measuring the increase in absorbance at 583 nm.
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)
Not Found
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
§ 862.1475 Lipoprotein test system.
(a)
Identification. 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 (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
0
| 510(k) Summary | K012287 |
|---|---|
| Introduction | According to the requirements established in the Food and Drug |
| Administration's guidance document entitled "The New 510(k) Paradigm: | |
| Alternate Approaches to Demonstrating Substantial Equivalence in Premarket | |
| Notifications", 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 Road | |
| Indianapolis, IN 46250 | |
| (317) 521 - 3831 | |
| Contact Person: Sherri L. Coenen | |
| Date Prepared: July 17, 2001 | |
| Device Name | Proprietary name: LDL-Cholesterol plus 2nd Generation |
| Common name: LDL-Cholesterol | |
| Classification name: Lipoprotein test system | |
| Predicate | |
| Device | We claim substantial equivalence to the currently marketed Roche/Hitachi |
| LDL-Cholesterol plus 2nd generation assay (K974733). | |
| Device | |
| Description | The LDL-Cholesterol plus 2nd Generation test principle is based on the |
| selective micellary solubilization of LDL-cholesterol by a nonionic detergent | |
| and the interaction of a sugar compound and lipoproteins. The inclusion of a | |
| sugar compound and a detergent in the enzymatic method for cholesterol | |
| determination (cholesterol esterase cholesterol oxidase coupling reaction) | |
| enables the selective determination of LDL-cholesterol. The color intensity of | |
| the blue quinoneimine dye formed is directly proportional to the LDL- | |
| Cholesterol concentration. It is determined by measuring the increase in | |
| absorbance at 583 nm. | |
| Intended use | The cassette COBAS Integra LDL-Cholesterol plus 2nd Generation contains |
| an in vitro diagnostic reagent system intended for use on COBAS Integra | |
| systems for the quantitative determination of LDL-Cholesterol concentration | |
| in serum and plasma. | |
| Indications for | |
| Use | 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 (such as diabetes mellitus), atherosclerosis, and | |
| various liver and renal diseases. | |
| Substantial | |
| Equivalence | The proposed device is the LDL-Cholesterol plus 2nd generation reagent |
| packaged for and applied to the COBAS Integra family of analyzers. The | |
| COBAS Integra family application described in this submission is, in our | |
| opinion, substantially equivalent to the predicate device. | |
| Comparison to | |
| predicate | |
| device | The COBAS Integra application of the LDL-Cholesterol plus 2nd generation |
| assays has the same intended use and indication for use, the same scientific | |
| principle, the same formulation and similar application parameters as the | |
| predicate device, the LDL-Cholesterol plus 2nd generation assay as applied to | |
| the Roche/Hitachi family of analyzers. |
్రామం
1
510(k) Summary, Continued
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three overlapping, abstract shapes that resemble birds in flight or flowing lines, creating a sense of movement and connection.
AUG - 7 2001
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Sherri L. Coenen Regulatory Submissions, Centralized Diagnostics Roche Diagnostics Corporation 9115 Hague Road PO Box 50457 Indianapolis, IN 46250-0457
510(k) Number: K012287 Re: Trade/Device Name: LDL-Cholesterol plus 2nd Generation Regulation Number: 862.1475 Regulatory Class: I, reserved by limitations Product Code: MRR Dated: July 17, 2001 Received: July 20, 2001
Dear Ms. Coenen:
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 to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Ameradments, 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 ur general of 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 ( remainer ripps of the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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.
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Page 2
This letter will allow you to begin marketing your device as described in your 510(k) premarket I mis letter will and w you to organ substantial equivalence of your device to a legally marketed notification. The I Dr Intelligence scation 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 additionally 607.10 for in in in the promotion and advertising of your device, (201) 594-4508. 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 miountation on your responsionies and in the more (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
4
Indications for Use Statement
510(k) Number (if known): N/A K012287
Device Name: LDL-Cholesterol plus 2nd Generation
Indications For Use:
The cassette COBAS Integra LDL-Cholesterol plus 2nd Generation (HDL-C) contains an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of LDL-Cholesterol concentration 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 (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Kesia Alexander Sr. Iian Cooper
510/k) Number