(191 days)
For in vitro diagnostic use only. VITROS Chemistry Products dHDL Slides are used to quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma using VITROS 250/350/950/5, I FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. High Density Lipoprotein (HDL) cholesterol is used to evaluate the risk of developing coronary heart disease (CHD). The risk of CHD increases with lower HDL cholesterol concentrations.
The VITROS dHDL assay is performed using the VITROS Chemistry Products dHDL Slide and the VITROS Chemistry Products Calibrator Kit 25 on the VITROS Chemistry Systems. The VITROS dHDL Slide is a multi-layered analytical element coated on a polyester support. The method is based on a non-HDL precipitation method followed by an enzymatic detection. All reactions necessary for a single quantitative measurement of HDLC take place within the multi-layered analytical element of a VITROS Chemistry Products dHDL Slide. A drop of sample fluid is metered onto the slide and a reaction occurs which ultimately generates a colored dye. The density of dye formed is proportional to the HDL Cholesterol concentration present in the sample and is measured by reflectance spectrophotometry.
The provided document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of clinical performance metrics like sensitivity, specificity, or reader studies for an AI device.
This document describes a Special 510(k) submission for a modification to an existing in vitro diagnostic (IVD) device, the VITROS Chemistry Products dHDL Slide, used to measure HDL cholesterol. The modification primarily involves a reduction in the physical size of the slide and consequently a reduction in the reagents per slide and the sample volume required per test, without changing the fundamental technology or intended use.
Therefore, the requested information elements related to AI device performance evaluation (e.g., sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of device and submission.
The "study" conducted for this submission would have focused on demonstrating that despite the physical changes, the modified device performs equivalently to the predicate (unmodified) device in terms of analytical performance. This would typically involve analytical studies like method comparison, precision, linearity, and interference testing, not clinical performance studies as would be conducted for a new AI-powered diagnostic.
Here's what can be extracted and inferred from the document regarding the device and its evaluation:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria (Inferred from a Special 510(k) for device modification): The primary acceptance criterion for this type of submission is demonstrating substantial equivalence to the predicate device. This means the modified device must perform comparably to the predicate device for its intended use, with no new questions of safety or effectiveness raised. Specifically, for an IVD, this generally means analytical performance (e.g., accuracy, precision, linearity, measuring range) should be equivalent. The document indicates that the concentration of ingredients per slide has changed, but the concentration of ingredients in the assay reaction remains the same, which is key to maintaining performance.
- Reported Device Performance: The document provides a summary stating: "The information presented in the premarket notification provides a reasonable assurance that the VITROS Chemistry Products dHDL Slides (modified) for use with human serum and plasma is substantially equivalent to the predicate (unmodified VITROS dHDL Slide) and is safe and effective for the stated intended use." This statement is the ultimate "reported performance" in the context of a 510(k) submission, confirming that the device meets the regulatory standard of substantial equivalence. Specific analytical performance metrics (e.g., bias, correlation coefficients between modified and predicate device results) are not detailed in this summary but would have been part of the full 510(k) submission to demonstrate equivalence.
2. Sample size used for the test set and the data provenance:
* Not applicable / Not explicitly stated in this summary. This document is a summary of a Special 510(k), which focuses on modifications to an existing device. The "test set" in this context refers to samples used for analytical verification and validation (e.g., method comparison, precision studies), not a clinical test set for AI performance. The details of these analytical studies (number of samples, study design) are not included in this summary document.
* Data Provenance: Not specified in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable. This is an in vitro diagnostic device for quantitative measurement of HDL cholesterol. The "ground truth" for such a device is established by qualified laboratory methods (e.g., CDC reference methods, other validated clinical laboratory analyzers) or reference materials, not by human expert interpretation of images or other subjective data. Human experts are typically involved in interpreting the results in a clinical context, but not in establishing the "ground truth" for the device's measurement performance itself.
4. Adjudication method for the test set:
* Not applicable. See point 3.
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:
* Not applicable. This device is an automated in vitro diagnostic assay, not an AI-powered image analysis or diagnostic support system for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
* Not applicable. This is an automated laboratory test, not an AI algorithm. Its performance is inherently "standalone" in the sense that it provides a quantitative result without human subjective interpretation of an image or pattern.
7. The type of ground truth used:
* Inferred: For an IVD measuring HDL cholesterol, the ground truth for establishing analytical performance typically comes from:
* Reference methods: Comparability to established, validated reference methods (e.g., CDC-certified reference methods for lipid measurements).
* Certified reference materials: Materials with known, traceable concentrations of the analyte.
* Standard clinical laboratory analyzers: Comparison to existing, cleared devices in a method comparison study.
8. The sample size for the training set:
* Not applicable. This is not a machine learning or AI device that requires a "training set."
9. How the ground truth for the training set was established:
* Not applicable. This is not a machine learning or AI device.
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SEP 7 2012
i
Special 510(k) SUMMARY
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR
807.92.
| Submitter Information | ||
|---|---|---|
| Name | Ortho Clinical Diagnostics | |
| Address | 100 Indigo Creek Drive, Rochester, NY 14626, USA | |
| Phone number | (585) 453-4041 | |
| Fax number | (585) 453-3368 | |
| EstablishmentRegistration Number | 1319809 | |
| Name of contactperson | Marlene A. Hanna | |
| Date prepared | February 24, 2012 | |
| Name of device | ||
| Trade or proprietaryname | VITROS Chemistry Products dHDL Slide | |
| Common or usualname | HDL Cholesterol assay | |
| Classification name | Lipoprotein test system | |
| Classification panel | Clinical Chemistry | |
| Regulation | 21 CFR 862.1475 | |
| Product Code(s) | LBS | |
| Legally marketed device(s)to which equivalence isclaimed | The VITROS Chemistry Products dHDL Slide (modified) are substantiallyequivalent to the VITROS Chemistry Products dHDL Slides (current slide).The FDA cleared the VITROS Chemistry Products dHDL Slides on October26, 2004 (K042006). | |
| Reason for 510(k)submission | A Special 510(k) for a modification to own device which does not include a changein intended use or fundamental technology. Each modified VITROS dHDL Slide willhave 30% less ingredients compared to the current VITROS dHDL Slide as a resultof a smaller surface area. Since the reduction in ingredients per slide is due to asmaller surface area, the concentration of ingredients of the modified slide will beunchanged compared to the current slide. The device modification results in areduction in the sample volume required per test from 10 µL per test to 6 µL per test. | |
| Device description | The VITROS dHDL assay is performed using the VITROS Chemistry ProductsdHDL Slide and the VITROS Chemistry Products Calibrator Kit 25 on the VITROSChemistry Systems. The VITROS dHDL Slide is a multi-layered analytical elementcoated on a polyester support. The method is based on a non-HDL precipitationmethod followed by an enzymatic detection. All reactions necessary for a singlequantitative measurement of HDLC take place within the multi-layered analyticalelement of a VITROS Chemistry Products dHDL Slide. A drop of sample fluid ismetered onto the slide and a reaction occurs which ultimately generates a coloreddye. The density of dye formed is proportional to the HDL Cholesterol concentrationpresent in the sample and is measured by reflectance spectrophotometry. | |
| Intended use of the device | For in vitro diagnostic use only. VITROS Chemistry Products dHDL Slides are usedto quantitatively measure HDL cholesterol (HDLC) concentration in serum andplasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and theVITROS 5600 Integrated System. High Density Lipoprotein (HDL) cholesterol isused to evaluate the risk of developing coronary heart disease (CHD). The risk ofCHD increases with lower HDL cholesterol concentrations. | |
| Indications for use | High Density Lipoprotein (HDL) cholesterol is used to evaluate the risk of developingcoronary heart disease (CHD). The risk of CHD increases with lower HDLcholesterol concentrations. | |
| Summary of the technological characteristics of the device compared to the predicate device | ||
| Characteristic | New Device[ Modified VITROS dHDLSlide] | Predicate [VITROS dHDL Slide][K042006] |
| Intended Use | Same | For in vitro diagnostic use only.VITROS Chemistry ProductsdHDL Slides are used toquantitatively measure HDLcholesterol (HDLC) concentrationin serum and plasma usingVITROS 250/350/950 and 5,1 FSand 4600 Chemistry Systems andthe VITROS 5600 IntegratedSystem. High Density Lipoprotein(HDL) cholesterol is used toevaluate the risk of developingcoronary heart disease (CHD).The risk of CHD increases withlower HDL cholesterolconcentrations. |
| Fundamental technology | Same | Dry, multilayered slide utilizingmethod based on a non-HDLprecipitation method followed byenzymatic detection, measuredby reflectance spectrophotometry. |
| Sample Volume Required | 6 μL | 10 μL |
| Instrumentation | Same | VITROS 250/350/950 and 5,1 FSand 4600 Chemistry Systems andthe VITROS 5600 IntegratedSystem. |
| Concentration of dHDLSlide Reactive Ingredientsper Slide (test) | Same | Emulgen B-66 0.7 mg;phosphotungstic acid 0.3 mg;magnesium chloride 0.2 mg,cholesterol oxidase(Cellulomonas, E.C.1.1.3.6) 0.8 U;cholesterol ester hydrolase(Candida rugosa, E.C.3.1.1.3) 1.2U; peroxidase (horseradish root,E.C.1.11.1.7) 2.2 U; and 2-(3,5-dimethoxy-4-hydroxyphenyl)-4,5-bis-(4-dimethylaminophenyl)imidazole (leuco dye) 0.02 mg |
| Amount of dHDL Slide ·Reactive Ingredients perSlide (test) | Emulgen B-66 0.63 mg; phosphotungsticacid 0.27 mg; magnesium chloride 0.15mg, cholesterol oxidase (Cellulomonas,E.C.1.1.3.6) 0.72 U; cholesterol esterhydrolase (Candida rugosa, E.C.3.1.1.3)1.10 U; peroxidase (horseradish root,E.C.1.11.1.7) 2.0 U; and 2- (3,5-dimethoxy-4-hydroxyphenyl)-4,5-bis-(4-dimethylaminophenyl) imidazole (leucodye) 0.018 mg. | Emulgen B-66 0.90 mg;phosphotungstic acid 0.38 mg;magnesium chloride 0.22 mg,cholesterol oxidase(Cellulomonas, E.C.1.1.3.6) 1.0 U;cholesterol ester hydrolase(Candida rugosa, E.C.3.1:1.3)1.56 U; peroxidase (horseradishroot, E.C.1.11.1.7) 2.82 U; and 2-(3,5-dimethoxy-4-hydroxyphenyl)-4,5-bis-(4-dimethylaminophenyl)imidazole (leuco dye) 0.026 mg |
| Sample Type | Same | Serum, plasma |
| Measuring Range | Same | 5.0 - 110.0 mg/dL |
| CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA | ||
| The information presented in the premarket notification provides a reasonable assurance that the VITROSChemistry Products dHDL Slides (modified) for use with human serum and plasma is substantially equivalentto the predicate (unmodified VITROS dHDL Slide) and is safe and effective for the stated intended use. |
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
November 26, 2012
Ortho-Clinical Diagnostics, Inc. c/o Marlene Hanna 100 Indigo Creek Drive Rochester, NY 14626-5101
K120609 Trade Name: VITROS Chemistry Products dHDL Slides Regulation Number: 21 CFR §862.1475 Regulation Name: Lipoprotein Test System Regulatory Class: Class I, meets limitations of exemption 862.9 (c)(4) Product Codes: LBS Dated: August 9, 2012 Received: August 10, 2012
Dear Ms. Hanna:
Re:
This letter corrects our substantially equivalent letter of September 7, 2012.
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 (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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Marlene Hanna
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Carol C. Benson
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
for
Enclosure
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Indication for Use
510(k) Number (if known): 长 \ 2 こ こ こ こ こ こ こ こ こ こ こ こ こ こ こ こ こ こ 。
Device Name: VITROS Chemistry Products dHDL Slides
Indication For Use: For in vitro diagnostic use only. VITROS Chemistry Products dHDL Slides are used to quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma using VITROS 250/350/950/5, I FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. High Density Lipoprotein (HDL) cholesterol is used to evaluate the risk of developing coronary heart disease (CHD). The risk of CHD increases with lower HDL cholesterol concentrations.
Prescription Use _ X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
R. t. Chisholm
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K120609
Page 1 of 1
§ 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.