(62 days)
No
The summary describes a standard automated clinical chemistry analyzer and associated reagents, with no mention of AI or ML technologies.
No.
The device is described as being "For in vitro diagnostic use only" and is used to measure LDL cholesterol concentration in serum and plasma, which are diagnostic purposes, not therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only" and further specifies that the reagent "is used to quantitatively measure LDL Cholesterol (LDLC) concentration in serum and plasma" to "evaluate the risk of developing coronary heart heart disease (CHD)," which are all diagnostic purposes.
No
The device description clearly outlines a system comprised of instrumentation (the VITROS 5.1 FS Chemistry System), liquid reagents, thin film products, and common reagents. This indicates a physical, hardware-based system, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only" multiple times for the dLDL Reagent, Calibrator Kit 19, and Performance Verifiers I and II.
- Purpose: The device is used to measure LDL Cholesterol concentration in serum and plasma, which are human specimens. This measurement is used to evaluate the risk of developing coronary heart disease (CHD), a medical condition.
- Components: The description details reagents, calibrators, and controls that are used to perform the assay on human specimens. These are all typical components of an IVD system.
- Regulatory Information: The mention of 510(k) premarket notifications (K numbers) is a strong indicator that the device is regulated as a medical device, specifically an IVD, by the FDA.
The entire description points to a system designed to perform diagnostic tests on biological samples outside of the body, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For in vitro diagnostic use only. VITROS Chemistry Products dLDL Reagent is used to quantitatively measure LDL Cholesterol (LDLC) concentration in serum and plasma. Low Density Lipoprotein (LDL) cholesterol is used to evaluate the risk of developing coronary heart disease (CHD). The risk of CHD increases with higher LDL cholesterol concentrations.
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 19 is used in conjunction with VITROS FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of HDL and LDL cholesterol using VITROS dHDL and dLDL Reagents.
For in vitro diagnostic use only. VITROS Chemistry Products Performance Verifiers I and II are assayed controls used to monitor performance on VITROS Chemistry Systems.
Product codes (comma separated list FDA assigned to the subject device)
JIT, JJX, MRR
Device Description
The VITROS 5.1 FS Chemistry System is a fully automated clinical chemistry analyzer intended for use in the in vitro determination of various analytes in human specimens (serum, plasma, urine, and cerebrospinal fluid). The VITROS 5,1 FS is designed for use with VITROS Chemistry Products MicroTip and Thin Film assays.
The system is comprised of four main elements:
- The VITROS 5,1 FS Chemistry System instrumentation, which provides automated use of the chemistry reagents. The VITROS 5.1 FS Chemistry System was cleared for market by a separate 510(k) premarket notification (K031924).
- The VITROS Chemistry Products MicroTip range of liquid reagent products (in this case VITROS Chemistry Products dLDL Reagent, VITROS Chemistry Products Calibrator Kit 19 and VITROS Chemistry Products FS Calibrator 1, VITROS Chemistry Products Performance Verifiers I and II), which are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS dLDL assay.
- The VITROS Chemistry Products Thin Film range of dry products, which are dry, multilayered, analytical elements, coated on polyester supports. The thin film products each have there own 510(k) clearance numbers and were cleared for market for use on the VITROS 5.1 FS Chemistry System through submission of information required by the ODE Guidance Document: "Data For Commercialization Of Original Equipment Manufacturer, Secondary and Generic Reagents For Automated Analyzers". The required information was provided in the VITROS 5.1 FS Chemistry System premarket notification (K031924).
- Common reagents used by multiple assays on the VITROS System (in this case, VITROS Chemistry Products FS Diluent Pack 2 and VITROS Chemistry Products FS Reconstitution Diluent).
The VITROS System and reagents are designed specifically for use with the VITROS Chemistry Products range of products.
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
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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)
Studies were performed to determine the precision, specificity, linearity, and expected values of the VITROS dLDL assay. The relationship between the VITROS dLDL and the predicate device was determined by least squares linear regression: VITROS dLDL = 1.031 x X - 3.81 (mg/dL), with a correlation coefficient of 0.9908.
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.
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
Chapter 1 - Summary Information
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: KOY 1720
-
Ortho-Clinical Diagnostics, Inc. Submitter 1. name, 100 Indigo Creek Drive address, Rochester, New York 14626-5101 (585) 453-4041 contact
Contact Person: Marlene A. Hanna -
Date 510(k) prepared: June 23, 2004 2. Preparation date
-
Trade or Proprietary Name: 3. Device VITROS Chemistry Products dLDL Reagent name VITROS Chemistry Products Calibrator Kit 19 VITROS Chemistry Products FS Calibrator 1 VITROS Chemistry Products Performance Verifiers I and II
Common Name: Direct LDL assay
Classification Name: Lipoprotein test system (862.1475): Class: I: The Clinical Chemistry and Toxicology Panel of the FDA has placed lipoprotein test systems in Class I. Since this device is an in vitro device intended for use in assessing the risk of cardiovascular diseases, it meets the reserved criteria under Section 510(1) of the Food, Drug, and Cosmetic Act.
Classification Name: Quality Control material (assayed and unassayed) (862.1660): Class I: The Clinical Chemistry and Toxicology Panel of the FDA has placed Quality Control material (assayed and unassayed) for clinical chemistry in Class I. Since this device is an assayed control, it meets the reserved criteria under Section 510(1) of the Food, Drug, and Cosmetic Act.
1
510(k) Summary, Continued
-
a. The VITROS Chemistry Products dLDL assay is substantially equivalent to the 4. Predicate Polymedco Lipi+Plus Direct LDL assay. Device
b. The VITROS Chemistry Products Performance Verifiers I and II are substantially equivalent to the VITROS Chemistry Products Performance Verifiers I and II. -
The VITROS 5.1 FS Chemistry System is a fully automated clinical chemistry 5. Device analyzer intended for use in the in vitro determination of various analytes in human description specimens (serum, plasma, urine, and cerebrospinal fluid). The VITROS 5,1 FS is designed for use with VITROS Chemistry Products MicroTip and Thin Film assays.
The system is comprised of four main elements: -
- The VITROS 5,1 FS Chemistry System instrumentation, which provides automated use of the chemistry reagents. The VITROS 5.1 FS Chemistry System was cleared for market by a separate 510(k) premarket notification (K031924).
-
- The VITROS Chemistry Products MicroTip range of liquid reagent products (in this case VITROS Chemistry Products dLDL Reagent, VITROS Chemistry Products Calibrator Kit 19 and VITROS Chemistry Products FS Calibrator 1, VITROS Chemistry Products Performance Verifiers I and II), which are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS dLDL assay.
-
- The VITROS Chemistry Products Thin Film range of dry products, which are dry, multilayered, analytical elements, coated on polyester supports. The thin film products each have there own 510(k) clearance numbers and were cleared for market for use on the VITROS 5.1 FS Chemistry System through submission of information required by the ODE Guidance Document: "Data For Commercialization Of Original Equipment Manufacturer, Secondary and Generic Reagents For Automated Analyzers". The required information was provided in the VITROS 5.1 FS Chemistry System premarket notification (K031924).
-
- Common reagents used by multiple assays on the VITROS System (in this case, VITROS Chemistry Products FS Diluent Pack 2 and VITROS Chemistry Products FS Reconstitution Diluent).
The VITROS System and reagents are designed specifically for use with the VITROS Chemistry Products range of products.
2
a. VITROS Chemistry Products dLDL Reagent: For in vitro diagnostic use only. 6. Device intended The VITROS Chemistry Products dLDL Reagent is used to quantitatively measure LDL Cholesterol (LDLC) concentration in serum and plasma. Low Density use Lipoprotein (LDL) cholesterol is used to evaluate the risk of developing coronary heart disease (CHD). The risk of CHD increases with higher LDL cholesterol concentration.
b. VITROS Chemistry Products Calibrator Kit 19 and VITROS Chemistry Products FS Calibrator 1: For in vitro diagnostic use only. The VITROS Chemistry Products Calibrator Kit 19 is used in conjunction with VITROS FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of HDL and LDL cholesterol using VITROS dHDL and dLDL Reagents.
c. VITROS Chemistry Products Performance Verifiers I and II: For in vitro diagnostic use only. The VITROS Chemistry Products Performance Verifiers I and II are assayed controls used to monitor performance on VITROS Chemistry Systems.
7. Comparison to predicate device(s):
Reagent Pack and Calibrators
The VITROS Chemistry Products dLDL Reagent and VITROS Chemistry Products Calibrator Kit 19 and FS Calibrator 1 are substantially equivalent to the Polymedco Lipi+Plus Direct LDL assay (predicate device) which was cleared by the FDA (K020852) for IVD use.
The relationship between the VITROS dLDL and the predicate device, determined by least squares linear regression, is:
VITROS dLDL = 1.031 x X - 3.81 (mg/dL), with a correlation coefficient of 0.9908, where X is the Polymedco Lipi+Plus Direct LDL assay on a Dade Dimension clinical chemistry analyzer.
In addition to the above mentioned correlation study, studies were performed to determine the precision, specificity, linearity, and expected values of the VITROS dLDL assay, (refer to the VITROS dLDL Reagent Instructions for Use for summaries of the results of these studies).
3
510(k) Summary, Continued
Table 1 lists the characteristics of the assays performed using the VITROS dLDL assay and the Polymedco Lipi+Plus Direct LDL assay.
| Device
Characteristic | VITROS dLDL
(New device) | dLDL
(Predicate device) |
|---------------------------|--------------------------------------------|---------------------------------------------|
| Reportable Range | 30 - 350 mg/ dL | 0 - 1000 mg/dL |
| Specimen Pretreatment | None Required:
Homogeneous assay | None Required:
Homogeneous assay |
| Basic Principle | Elimination enzymatic test | Elimination enzymatic test |
| Reagents | Liquid ready to use | Liquid ready to use |
| Instrumentation | VITROS 5,1 FS Chemistry
System | Dade Dimension clinical
chemistry system |
| Sample Type | Serum and Plasma (heparin) | Serum and Plasma (heparin
and EDTA) |
| Reaction steps | Step 1: Elimination
Step 2: Measurement | Step 1: Elimination
Step 2: Measurement |
| Incubation
Temperature | 37 °C | 37 °C |
Table 1 lists the characteristics of the VITROS dLDL (new device) and the dLDL Table 1
Performance Verifiers
The VITROS Chemistry Products Performance Verifiers I and II are substantially equivalent to the VITROS Chemistry Products Performance Verifiers (predicate device) which were cleared by the FDA (K904768) for IVD use.
Table 2
Table 2 lists the similarities and differences of the device characteristics between the VITROS Performance Verifiers with the predicate device, VITROS Performance Verifiers I and II.
| Device
| Characteristic | VITROS dLDL (New device) | dLDL (Predicate device) |
|---|---|---|
| Intended Use | VITROS Performance Verifier is an assayed control used to monitor performance on VITROS Chemistry Systems. (New additional intended use: to monitor performance of LDL Cholesterol on the VITROS 5,1 FS Chemistry System.) | VITROS Performance Verifier is an assayed control used to monitor performance on VITROS Chemistry Systems. |
| Matrix of | ||
| Performance | ||
| Verifiers | A base matrix of freeze-dried human serum to which enzymes, electrolytes, stabilizers, preservatives and other organic analytes have been added. | A base matrix of freeze-dried human serum to which enzymes, electrolytes, stabilizers, preservatives and other organic analytes have been added. |
| Performance | ||
| Verifier Levels | Low and High | Low and High |
4
510(k) Summary, Continued
The data presented in the premarket notification provide a reasonable assurance Conclusions that the VITROS dLDL assay and the VITROS Chemistry Products Performance Verifiers are safe and effective for the stated intended uses and are substantially equivalent to the cleared predicate devices. The data in this premarket notification demonstrate that the performance of the VITROS dLDL assay and Performance Verifiers are substantially equivalent to the cleared predicate device(s).
Equivalence to predicate(s) was demonstrated using commercially available reagents along with patient samples.
5
Image /page/5/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo consists of a symbol resembling a stylized human figure with three wavy lines extending from its head, all enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the perimeter of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Marlene A. Hanna, RAC Regulatory Affairs Associate Ortho-Clinical Diagnostics 100 Indigo Creek Drive Rochester, NY 14626-5101
AUG 2 5 2004
K041720 Re:
Trade/Device Name: VIRTOS Chemistry Products dLDL Reagent VIRTOS Chemistry Products Calibrator Kit 19 VIRTOS Chemistry Products FS Calibrator 1 VIRTOS Chemistry Products Performance Verifiers I and II Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT, JJX, MRR, Dated: June 23, 2004 Received: June 24, 2004
Dear Ms. Hanna:
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).
6
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.
Jean M. Corgan, MS, DVM.
Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
| Indications for Use | |
|---|---|
| 510(k) Number (if known): | K041720 |
| Device Name(s): | VITROS Chemistry Products dLDL Reagent |
| VITROS Chemistry Products Calibrator Kit 19 | |
| VITROS Chemistry Products FS Calibrator 1 | |
| VITROS Chemistry Products Performance Verifiers I and II | |
| Indications for Use: | For in vitro diagnostic use only. VITROS Chemistry Products dLDL Reagent is used to quantitatively measure LDL Cholesterol (LDLC) concentration in serum and plasma. Low Density Lipoprotein (LDL) cholesterol is used to evaluate the risk of developing coronary heart disease (CHD). The risk of CHD increases with higher LDL cholesterol concentrations. |
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 19 is used in conjunction with VITROS FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of HDL and LDL cholesterol using VITROS dHDL and dLDL Reagents.
For in vitro diagnostic use only. VITROS Chemistry Products Performance Verifiers I and II are assayed controls used to monitor performance on VITROS Chemistry Systems. |
| Prescription Use
(Per 21 CFR 801 Subpart D) | AND/OR &p> |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Caul Benson
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K041720