(26 days)
The cassette COBAS Integra Cholesterol Gen.2 (CHOL2) contains an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of total cholesterol in serum and plasma.
Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in blood and lipoprotein metabolism disorders.
The COBAS Integra Cholesterol Gen.2 is an enzymatic colorimetric assay using cholesterol esterase, cholesterol oxidase, and peroxidase to form a red quinone-imine dye. The color intensity of the dye is directly proportional to the cholesterol concentration.
The provided text does not contain detailed acceptance criteria or a study proving the device meets acceptance criteria in the format requested. The document is a 510(k) summary for the COBAS Integra Cholesterol Gen.2 device, primarily focusing on its substantial equivalence to a predicate device.
However, based on the information provided, here's what can be inferred and what is explicitly stated:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state acceptance criteria in a structured table. Instead, it compares the proposed device's "Measuring range" to the predicate device. This "Measuring range" can be considered a performance characteristic.
| Performance Characteristic | Acceptance Criteria (from Predicate Device) | Reported Device Performance (COBAS Integra Cholesterol Gen.2) |
|---|---|---|
| Measuring range | 3 - 800 mg/dl | 0.1 - 800 mg/dl |
Note: The proposed device actually claims a wider lower detection limit (0.1 mg/dl) compared to the predicate (3 mg/dl), which is an improvement and would implicitly meet or exceed the predicate's lower limit as an "acceptance criterion."
2. Sample size 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 given text. The 510(k) summary is a high-level overview and does not delve into the specifics of study design or sample sizes for validation.
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 given text. For an in vitro diagnostic device like a cholesterol assay, the "ground truth" is typically established by reference methods or laboratory standards, not by human expert interpretation in the same way it would be for imaging devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the given text. As mentioned above, for this type of device, adjudication by multiple human experts is typically not the method for establishing "ground truth."
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:
This information is not applicable and not provided in the given text. The COBAS Integra Cholesterol Gen.2 is an automated in vitro diagnostic assay, not an AI-assisted diagnostic tool that would involve human readers interpreting output. Therefore, an MRMC study related to human improvement with AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The device itself is a standalone algorithm/system (an enzymatic colorimetric assay) for quantitative determination of cholesterol. Its performance is evaluated through analytical studies (e.g., accuracy, precision, linearity, interference) rather than "human-in-the-loop" studies. The document mentions "Enzymatic, colorimetric test" and "quantitative determination," implying a standalone analytical performance. However, specific details of these studies are not provided in this summary.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For a quantitative diagnostic assay like cholesterol, the "ground truth" would typically be established by:
- Reference materials/standards: Calibrated solutions with known cholesterol concentrations.
- Reference methods: Highly accurate and precise laboratory methods (e.g., isotope dilution mass spectrometry) against which the device's measurements are compared.
The document does not explicitly state the ground truth method but implies it would be based on established analytical standards for cholesterol measurement.
8. The sample size for the training set:
This information is not provided in the given text. As an enzymatic assay, it doesn't have a "training set" in the machine learning sense. Its development involves chemical optimization and analytical validation, not data training.
9. How the ground truth for the training set was established:
This information is not applicable as there is no "training set" for this type of device in the context of machine learning. The "ground truth" for its development would be based on fundamental chemical and biological principles, and then validated against established analytical standards and reference methods during its performance characterization.
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031824
510(k) Summary - COBAS Integra Cholesterol Gen.2
| 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 Corporation9115 Hague RdIndianapolis IN 46250(317) 521-3831Contact person: Sherri L. CoenenDate prepared: June 11, 2003 |
| Device Name | Proprietary name: Roche Diagnostics COBAS Integra Cholesterol Gen.2Common name: Total Cholesterol AssayClassification name: Cholesterol (Total) test system |
| Device description | The COBAS Integra Cholesterol Gen.2 is an enzymatic colorimetric assay using cholesterol esterase, cholesterol oxidase, and peroxidase to form a red quinone-imine dye. The color intensity of the dye is directly proportional to the cholesterol concentration. |
| Intended use | The cassette COBAS Integra Cholesterol Gen.2 (CHOL2) contains an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of total cholesterol in serum and plasma. |
| Predicate Device | We claim substantial equivalence to the currently marketed Roche/Hitachi Cholesterol Assay. (K952127). |
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510(k) Summary - COBAS Integra Creatinine plus ver.2,
continued
The following table describes the similarities and differences between the Reagent Summary COBAS Integra Cholesterol Gen.2 and the predicate device.
| Topic | Roche Hitachi Cholesterol (K952127) | COBAS Integra Cholesterol Gen.2 (Modified Device) |
|---|---|---|
| Intended Use | Enzymatic in vitro test for the directquantitative determination ofcholesterol in human serum andplasma on automated clinicalchemistry analyzers. | The cassette COBAS IntegraCholesterol Gen.2 (CHOL2) containsan in vitro diagnostic reagent systemintended for use on COBAS Integrasystems for the quantitativedetermination of total cholesterol inserum and plasma. |
| Method | Enzymatic, colorimetric test | Same |
| Sample type | Human Serum and Plasma | Same |
| Measuringrange | 3 - 800 mg/dl | 0.1 - 800 mg/dl |
| Expectedvalues | According to the recommendations ofthe European Atherosclerosis Societyand the recommendations of theNCEP Adult Treatment Panel. | Same |
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings and three curved lines representing its body. The seal is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
9 2003 JUL
Ms. Sherri L. Coenen Regulatory Affairs Consultant Regulatory Submissions, Centralized Diagnostics Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457
Re: K031824
Trade/Device Name: COBAS Integra Cholesterol Gen 2 Regulation Number: 21 CFR 862.1175 Regulation Name: Cholesterol (total) test system Regulatory Class: Class I Product Code: CHH Dated: June 11, 2003 Received: June 13, 2003
Dear Ms Coenen:
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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Page 2 -
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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): - MA
Device Name: COBAS Integra Cholesterol Gen. 2
Indications For Use:
The cassette COBAS Integra Cholesterol Gen.2 (CHOL2) contains an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of total cholesterol in serum and plasma,
Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in blood and lipoprotein metabolism disorders,
Jean Copy
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K031824
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF 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) |
§ 862.1175 Cholesterol (total) test system.
(a)
Identification. A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.(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.