(63 days)
No
The description focuses on a standard automated clinical chemistry analyzer and its associated reagents, with no mention of AI or ML capabilities.
No
The device is described as an "in vitro diagnostic use only" system used for quantitative measurements of apolipoproteins in human specimens, which aids in diagnosis and treatment monitoring, but does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only" several times for the reagents, and notes that "Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases." The "Device Description" also refers to the system as a "fully automated clinical chemistry analyzer intended for use in the in vitro determination of various analytes in human specimens," indicating its role in diagnosis.
No
The device description clearly outlines a system comprised of instrumentation (a fully automated clinical chemistry analyzer), liquid reagents, dry products (thin films), and common reagents. This indicates a significant hardware and chemical component, 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 reagents, calibrators, and performance verifiers.
- Measurement of Analytes in Human Specimens: The device description states that the system is intended for "in vitro determination of various analytes in human specimens (serum, plasma, urine, and cerebrospinal fluid)." This is a core characteristic of IVDs.
- Diagnosis and Treatment: The intended use of the ApoA1 and ApoB measurements is for "diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases." This directly relates to medical diagnosis and treatment, which is the purpose of IVDs.
- Reagents, Calibrators, and Controls: The description details the use of reagents, calibrators, and performance verifiers, which are all components typically used in in vitro diagnostic testing to ensure accurate and reliable results.
N/A
Intended Use / Indications for Use
For in vitro diagnostic use only. VITROS Chemistry Products ApoA1 Reagent is used to quantitatively measure apolipoprotein A1 (ApoA1) concentration in human 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. For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 21 is used to calibrate VITROS 5.1 FS Chemistry Systems for the quantitative measurement of apolipoprotein A 1 (ApoA1). For in vitro diagnostic use only. VITROS Chemistry Products ApoA1 Performance Verifier I is an assayed controls used to monitor the performance of ApoA1 Reagent on VITROS 5,1 FS Chemistry Systems.
For in vitro diagnostic use only. VITROS Chemistry Products ApoB Reagent is used to quantitatively measure apolipoprotein B (ApoB) concentration in human 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. For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 22 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of apolipoprotein B (ApoB). For in vitro diagnostic use only. VITROS Chemistry Products ApoB Performance Verifier I is an assayed controls used to monitor the performance of ApoB Reagent on VITROS 5,1 FS Chemistry Systems.
Product codes (comma separated list FDA assigned to the subject device)
JIT, MSJ, JJX
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 ApoA1 Reagent and VITROS Chemistry Products Calibrator Kit 21, VITROS Chemistry Products ApoB Reagent and VITROS Chemistry Products Calibrator Kit 22, VITROS Chemistry Products ApoA1 Performance Verifier I and VITROS Chemistry Products ApoB Performance Verifier I ), which are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS ApoA1 and ApoB assays.
- 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 their 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 1).
The VITROS System and reagents are designed specifically for use with the VITROS Chemistry Products range of products.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Correlation study performed to compare VITROS ApoA1 and ApoB assays with predicate devices using least squares linear regression.
- VITROS ApoA1 = 0.98 X - 13.04 (mg/dL), with a correlation coefficient of 0.987, where X is Dade Behring N Antisera to Human Apolipoprotein A-1 Reagent assay.
- VITROS ApoB = 1.00 X - 3.88 (mg/dL), with a correlation coefficient of 0.985, where X is Dade Behring N Antisera to Human Apolipoprotein B Reagent assay.
Additional studies performed to determine precision, specificity, linearity, antigen excess, lower limit of detection, and expected values of the VITROS ApoA1 and ApoB assays.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation coefficient for ApoA1: 0.987
Correlation coefficient for ApoB: 0.985
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
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 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: 长042521
- Ortho-Clinical Diagnostics, Inc. 1. Submitter 100 Indigo Creek Drive name, Rochester, New York 14626-5101 address, (585) 453-4041 contact Contact Person: Marlene A. Hanna
- Date 510(k) prepared: September 15, 2004 2. Preparation Date
- Trade or Proprietary Name(s): 3. Device VITROS Chemistry Products ApoA1 Reagent name VITROS Chemistry Products Calibrator Kit 21 VITROS Chemistry Products ApoA1 Performance Verifier I
VITROS Chemistry Products ApoB Reagent VITROS Chemistry Products Calibrator Kit 22 VITROS Chemistry Products ApoB Performance Verifier I
Common Name(s): Apolipoprotein A1 (ApoAl) assay Apolipoprotein B (ApoB) assay
Classification Name(s): Lipoprotein test systems (862.1475): Class: I (general controls). Since these devices (ApoA1 and ApoB reagent) are used in assessing risk of artherosclerosis, they meet the reserved criteria under Section 510(1) of the Food, Drug, and Cosmetic Act.
Calibrator (862.1150): Calibrator Kits 21 and 22: Class II.
Quality Control material (assayed and unassayed) (862.1660): Class I (general controls). Since these devices (ApoA1 and ApoB Performance Verifiers I) are assayed controls, they meet the reserved criteria under Section 510(1) of the Food, Drug, and Cosmetic Act.
1
- The VITROS Chemistry Products ApoA1 assay is substantially equivalent to 4. Predicate a. the Dade Behring N Antisera to Human Apolipoprotein A-1 Reagent and N Devices Apoliprotein Standard Serum.
- b. The VITROS Chemistry Products ApoB assay is substantially equivalent to the Dade Behring N Antisera to Human Apolipoprotein B Reagent and N Apoliprotein Standard Serum.
- The VITROS Chemistry Products ApoA1 and ApoB Performance Verifiers I ﻦ are substantially equivalent to the Dade Behring Apolipoprotein Control Serum CHD.
-
- Device 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 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 ApoA1 Reagent and VITROS Chemistry Products Calibrator Kit 21, VITROS Chemistry Products ApoB Reagent and VITROS Chemistry Products Calibrator Kit 22, VITROS Chemistry Products ApoA1 Performance Verifier I and VITROS Chemistry Products ApoB Performance Verifier I ), which are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS ApoA1 and ApoB assays.
-
- 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 their 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 1).
The VITROS System and reagents are designed specifically for use with the VITROS Chemistry Products range of products.
2
- a. VITROS Chemistry Products ApoA1 Reagent: For in vitro diagnostic use only. 6. Device(s) VITROS Chemistry Products ApoA1 Reagent is used to quantitatively measure intended apolipoprotein A1 (ApoA1) concentration in human serum and plasma. use
b. VITROS Chemistry Products ApoB Reagent: For in vitro diagnostic use only. VITROS Chemistry Products ApoB Reagent is used to quantitatively measure apolipoprotein B (ApoB) concentration in human serum and plasma.
c. VITROS Chemistry Products Calibrator Kit 21: For in vitro diagnostic use only, VITROS Chemistry Products Calibrator Kit 21 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of apolipoprotein A1 (ApoA1).
d. VITROS Chemistry Products Calibrator Kit 22: For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 22 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of apolipoprotein B (ApoB).
e. VITROS Chemistry Products ApoA1 Performance Verifier I: For in vitro diagnostic use only. VITROS Chemistry Products ApoA1 Performance Verifier I is an assayed control used to monitor the performance of ApoA1 Reagent on VITROS 5,1 FS Chemistry Systems.
f. VITROS Chemistry Products ApoB Performance Verifier I: For in vitro diagnostic use only. VITROS Chemistry Products ApoB Performance Verifier I is an assaved control used to monitor the performance of ApoB Reagent on VITROS 5,1 FS Chemistry Systems.
7. Comparison to predicate
device(s): Apo A1 Reagent Pack and Calibrators
The VITROS Chemistry Products ApoA1 Reagent and VITROS Chemistry Products Calibrator Kit 21 are substantially equivalent to the Dade Behring N Antisera to Human Apolipoprotein A-1 Reagent (K860894) and N Apoliprotein Standard Serum (K041870) (predicate devices) which were cleared by the FDA for IVD use.
3
The relationship between the VITROS ApoA1 and the predicate device, determined by least squares linear regression, is:
VITROS ApoA1 = 0.98 X - 13.04 (mg/dL),
with a correlation coefficient of 0.987,
where X is Dade Behring N Antisera to Human Apolipoprotein A-1 Reagent assay.
Apo B Reagent Pack and Calibrators
The VITROS Chemistry Products ApoB Reagent and VITROS Chemistry Products Calibrator Kit 22 are substantially equivalent to the Dade Behring N Antisera to Human Apolipoprotein B Reagent (K860894) and N Apoliprotein Standard Serum (K041870) (predicate devices) which were cleared by the FDA for IVD use.
The relationship between the VITROS ApoB and the predicate device, determined by least squares linear regression, is:
VITROS ApoB = 1.00 X - 3.88 (mg/dL),
with a correlation coefficient of 0.985, where X is Dade Behring N Antisera to Human Apolipoprotein B Reagent assay.
In addition to the above mentioned correlation study, studies were performed to determine the precision, specificity, linearity, antigen excess, lower limit of detection, and expected values of the VITROS ApoA1 and ApoB assays, (refer to the VITROS ApoA1 and ApoB Reagent's Instructions for Use for summaries of the results of these studies).
4
Table 1 lists the characteristics of the assays performed using the VITROS ApoA1 andApoB assays and the Dade Behring N Antisera to Human Apolipoprotein A-1 Reagent and the Dade Behring N Antisera to Human Apolipoprotein B Reagent assays.
- Table 1 lists the characteristics of the VITROS ApoA1 and ApoB (new devices) Table 1 and the DADE Apo A-1 and Apo B (predicate device).
| Device
Characteristic | VITROS ApoA1 and ApoB
(New device) | DADE Apo A-1 and ApoB
(Predicate device) |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For in vitro diagnostic use
only. VITROS Chemistry
Products ApoA1 and ApoB
Reagents are used to
quantitatively measure
apolipoprotein A1 (ApoA1)
and apolipoprotein B (ApoB)
concentration in human serum
and plasma. | In vitro diagnostic reagents for
the quantitative determination
of apolipoprotein A-1 (Apo A-
- and apolipoprotein B (Apo
B) in human serum. |
| Method | Immunoturbidimetric | Immunoturbidimetric |
| Reportable Range:
ApoA1:
ApoB: | 30.00-240.00 mg/dL
35.00-300.00 mg/dL | 19-600 mg/dL
25-400 mg/dL |
| Sample Type | Human Serum | Human Serum |
| Reactive Ingredients
ApoA1:
ApoB: | Goat antisera to human
apolipoprotein A1
Goat antisera to human
apolipoprotein B | Rabbit antisera to Human
ApoA-1
Rabbit antisera to Human
ApoB |
| Instrumentation | VITROS 5,1 FS Chemistry
System | DADE BN ProSpec |
5
Performance Verifiers
The VITROS Chemistry Products ApoA1 and ApoB Performance Verifiers I are substantially equivalent to the Dade Behring Apolipoprotein Control Serum CHD (predicate device) which was cleared by the FDA (K993310) for IVD use.
Table 2 lists the similarities and differences of the device characteristics between the VITROS ApoA1 and ApoB Performance Verifiers I with the predicate device, the Dade Behring Apolipoprotein Control Serum CHD.
Table 2
| Device
Characteristic | VITROS ApoA1 and ApoB
(New Device) | DADE ApoA1 and ApoB
(Predicate Device) |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For in vitro diagnostic use
only. VITROS Chemistry
Products ApoA1 and ApoB
Performance Verifiers I are
assayed controls used to
monitor the performance of
ApoA1 and ApoB Reagent on
VITROS 5,1 FS Chemistry
Systems. | Apolipoprotein Control
Serum CHD is used as an
assayed control for
accuracy and precision in
the quantitative
immunochemical
determination of
apolipoprotein A-1 and B
with the Behring
Nephelometer Systems. |
| Matrix | Prepared from processed
human serum to which
inorganic salts, buffers,
organic compounds, bovine
serum albumin, and
preservatives have been
added. | Stabilized reagent from
human serum. |
| Form | Liquid | Lyophilized |
| Volume | 0.5 mL per vial | 0.5 mL per vial |
Conclusions The data presented in the premarket notification provide a reasonable assurance that the VITROS ApoAl and ApoB assays and the VITROS Chemistry Products ApoA1 and ApoB Performance Verifiers are safe and effective for the stated intended uses and are substantially equivalent to the cleared predicate devices.
Equivalence to predicate(s) was demonstrated using commercially available reagents along with patient samples.
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Marlene A Hanna, RAC Regulatory Affairs Associate Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101
NOV 1 8 2004
Re: K042521
Trade/Device Name: VITROS Chemistry Products ApoA1 Reagent VITROS Chemistry Products Calibrator Kit 21 VITROS Chemistry Products ApoA1 Performance Verifier I VITROS Chemistry Products ApoB Reagent VITROS Chemistry Products Calibrator Kit 22 VITROS Chemistry Products ApoB Performance Verifier I Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT, MSJ, JJX Dated: September 15, 2004 Received: September 16, 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).
7
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,
Sincerely yours,
Cornelia B. Parks
Cornelia B. Rooks, MA Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
8
Indications for Use for the ApoA1 assay
510(k) Number (if known):
VITROS Chemistry Products ApoA1 Reagent Device Name(s): VITROS Chemistry Products Calibrator Kit 21 VITROS Chemistry Products ApoA1 Performance Verifier I Indications for Use: For in vitro diagnostic use only. VITROS Chemistry Products ApoA1 Reagent is used to quantitatively measure apolipoprotein A1 (ApoA1) concentration in human 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. For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 21 is used to calibrate VITROS 5.1 FS Chemistry Systems for the quantitative measurement of apolipoprotein A 1 (ApoA1). For in vitro diagnostic use only. VITROS Chemistry Products ApoA1 Performance Verifier I is an assayed controls used to monitor the performance of ApoA1 Reagent on VITROS 5,1 FS Chemistry Systems. ﺳﺎ
Prescription Use _ (Per 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (Per 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of
Carol Benn
Division Sign-Off
Office of in Vitro Diagnostic Devina Evaluation and Safety
510(k) K042521
9
Indications for Use for the ApoB assay
510(k) Number (if known):
| Device Name(s): | VITROS Chemistry Products ApoB Reagent |
|---|---|
| VITROS Chemistry Products Calibrator Kit 22 | |
| VITROS Chemistry Products ApoB Performance Verifier I | |
| Indications for Use: | For in vitro diagnostic use only. VITROS Chemistry Products ApoB Reagent is used to quantitatively measure apolipoprotein B (ApoB) concentration in human 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. |
| For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 22 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of apolipoprotein B (ApoB). | |
| For in vitro diagnostic use only. VITROS Chemistry Products ApoB Performance Verifier I is an assayed controls used to monitor the performance of ApoB Reagent on VITROS 5,1 FS Chemistry Systems. |
Prescription Use
(Per 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (Per 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 2 of 2 - 1
Carol Benner
Division Sign Off
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
EiO(k) K04252