(18 days)
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.
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.
The provided text is a 510(k) summary for a medical device called "LDL-Cholesterol plus 2nd Generation". This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study report with specific acceptance criteria and performance data for the currently submitted device.
Therefore, I cannot extract all the requested information, specifically regarding detailed acceptance criteria, reported device performance (with numerical metrics), sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance. The document primarily asserts equivalence based on shared principles, intended use, and formulation.
However, I can extract information related to the intended use and indications for use, which are foundational to what the device is designed to do, and the type of ground truth suggested by its purpose.
Here's what can be inferred or directly stated from the provided text:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the 510(k) summary. The document focuses on demonstrating substantial equivalence to a predicate device (Roche/Hitachi LDL-Cholesterol plus 2nd generation assay, K974733), stating that the proposed device has "the same intended use and indication for use, the same scientific principle, the same formulation and similar application parameters" as the predicate device. It does not present specific acceptance criteria or performance data for the new device's evaluation against those criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the 510(k) summary. This type of detail is typically associated with studies involving human interpretation or subjective assessments, which is not the primary focus for an in-vitro diagnostic reagent system aiming for quantitative measurement.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the 510(k) summary.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC study is not applicable and therefore, not done. This device is an in-vitro diagnostic reagent system for quantitative determination of LDL-Cholesterol, not an AI-assisted diagnostic tool requiring human interpretation comparison.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone diagnostic reagent system for quantitative determination. The performance mentioned in the summary is inherent to the reagent system and its application on the COBAS Integra systems, which intrinsically operates without human-in-the-loop during the analytical process. There's no separate "algorithm only" performance reported in the context of interpretation, as it's a direct measurement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Given the device's function, the ground truth would inherently be quantitative reference methods or established laboratory standards for LDL-Cholesterol measurement. The intention is to accurately measure LDL-Cholesterol concentration. This would typically involve comparison to a gold standard method for cholesterol determination or certified reference materials.
8. The sample size for the training set
This information is not provided in the 510(k) summary. For a diagnostic reagent, "training set" might refer to samples used during reagent development and optimization, but specific sizes are not reported here.
9. How the ground truth for the training set was established
This information is not provided in the 510(k) summary. Similar to the above, it would involve comparison to established methods for LDL-Cholesterol measurement during the development phase.
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| 510(k) Summary | K012287 |
|---|---|
| Introduction | According to the requirements established in the Food and DrugAdministration's guidance document entitled "The New 510(k) Paradigm:Alternate Approaches to Demonstrating Substantial Equivalence in PremarketNotifications", the following information provides sufficient detail tounderstand the basis for a determination of substantial equivalence. |
| Submittername, address,contact | Roche Diagnostics Corporation9115 Hague RoadIndianapolis, IN 46250(317) 521 - 3831 |
| Contact Person: Sherri L. CoenenDate Prepared: July 17, 2001 | |
| Device Name | Proprietary name: LDL-Cholesterol plus 2nd Generation |
| Common name: LDL-Cholesterol | |
| Classification name: Lipoprotein test system | |
| PredicateDevice | We claim substantial equivalence to the currently marketed Roche/HitachiLDL-Cholesterol plus 2nd generation assay (K974733). |
| DeviceDescription | The LDL-Cholesterol plus 2nd Generation test principle is based on theselective micellary solubilization of LDL-cholesterol by a nonionic detergentand the interaction of a sugar compound and lipoproteins. The inclusion of asugar compound and a detergent in the enzymatic method for cholesteroldetermination (cholesterol esterase cholesterol oxidase coupling reaction)enables the selective determination of LDL-cholesterol. The color intensity ofthe blue quinoneimine dye formed is directly proportional to the LDL-Cholesterol concentration. It is determined by measuring the increase inabsorbance at 583 nm. |
| Intended use | The cassette COBAS Integra LDL-Cholesterol plus 2nd Generation containsan in vitro diagnostic reagent system intended for use on COBAS Integrasystems for the quantitative determination of LDL-Cholesterol concentrationin serum and plasma. |
| Indications forUse | A lipoprotein test system is a device intended to measure lipoprotein in serumand plasma. Lipoprotein measurements are used in the diagnosis andtreatment of lipid disorders (such as diabetes mellitus), atherosclerosis, andvarious liver and renal diseases. |
| SubstantialEquivalence | The proposed device is the LDL-Cholesterol plus 2nd generation reagentpackaged for and applied to the COBAS Integra family of analyzers. TheCOBAS Integra family application described in this submission is, in ouropinion, substantially equivalent to the predicate device. |
| Comparison topredicatedevice | The COBAS Integra application of the LDL-Cholesterol plus 2nd generationassays has the same intended use and indication for use, the same scientificprinciple, the same formulation and similar application parameters as thepredicate device, the LDL-Cholesterol plus 2nd generation assay as applied tothe Roche/Hitachi family of analyzers. |
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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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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
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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
§ 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.