(77 days)
No
The summary describes a standard immunoassay system for measuring folate and vitamin B12. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies.
No.
The device is used for in vitro quantitative measurement of folate to aid in the differential diagnosis of anemia, not for treating a condition.
Yes
The intended use states that the device is "to aid in the differential diagnosis of anemia." This clearly indicates its role in diagnosing a condition.
No
The device description clearly outlines a system comprised of reagent packs, calibrators, and instrumentation, indicating a hardware component (the VITROS Immunodiagnostic System instrumentation) is essential to its function. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use explicitly states "for the in vitro quantitative measurement of folate in human serum and plasma (heparin) and whole blood (red cell folate), to aid in the differential diagnosis of anemia." The phrase "in vitro" is a key indicator of an IVD, meaning it's used outside of the living body. The purpose of measuring folate in human samples to aid in diagnosis also aligns with the definition of an IVD.
- Device Description: The description details a system that uses reagents and instrumentation to measure analytes in "human body fluids, commonly serum, plasma and urine." This further confirms its use with biological samples outside the body.
- Components: The system includes "Reagent Packs" and "Calibrators," which are typical components of IVD test kits used to perform measurements on biological samples.
- Predicate Device: The predicate device is a "Folate Radioassay," which is another type of IVD used for measuring folate in biological samples.
All of these points strongly indicate that this device is designed and intended for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
- & 2. The VITROS Immunodiagnostic Products Folate Reagent Pack 1/2 and the VITROS Immunodiagnostic Products Vitamin B12/Folate Reagent Pack 3 - for the in vitro quantitative measurement of folate in human serum and plasma (heparin) and whole blood (red cell folate), to aid in the differential diagnosis of anemia.
- The VITROS Immunodiagnostic Products Folate Calibrators - for in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of folate in human serum and plasma (heparin).
- The VITROS Immunodiagnostic Products Red Cell Folate Pack - for whole blood sample preparation, to allow the in vitro quantitative measurement of red cell folate using the VITROS Immunodiagnostic System.
Product codes (comma separated list FDA assigned to the subject device)
CGN
Device Description
The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum, plasma and urine. Coated microwells are used as the solid phase separation system.
The system is comprised of three main elements:
- The VITROS Immunodiagnostic Products range of products, in this case VITROS Immunodiagnostic Products Folate Reagent Pack, VITROS Immunodiagnostic Products Folate Calibrators and the VITROS Immunodiagnostic System. The VITROS Folate Reagent Pack consists of: The VITROS Immunodiagnostic Products Folate Reagent Pack 1/2 and the VITROS Immunodiagnostic Products Vitamin B12/Folate Reagent Pack 3
- The VITROS Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K962919).
- Common reagents used by the VITROS System in each assay. The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 510(k) pre-market notification (K984310).
The VITROS System and common reagents are dedicated specifically only for use with the VITROS Immunodiagnostic Products range of immunoassay products.
The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum. plasma and urine. Coated microwells are used as the solid phase separation system.
The system is comprised of three main elements:
- The VITROS Immunodiagnostic Products (in this case VITROS Immunodiagnostic Products Red Cell Folate Pack, VITROS Immunodiagnostic Products Folate Pack 1/2, VITROS Immunodiagnostic Products Vitamin B12/Folate Reagent Pack 3, VITROS Immunodiagnostic Products Folate Calibrators, which are combined by the VITROS Immunodiagnostic System to perform the VITROS Red Cell Folate assay).
- The VITROS Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K962919).
- Common reagents used by the VITROS System in each assay. The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 510(k) pre-market notification (K984310).
The VITROS System and common reagents are dedicated specifically only for use with the VITROS Immunodiagnostic Products range of immunoassay 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
Not Found
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)
Comparison of VITROS Folate assay to Predicate Device:
The relationship between the VITROS Folate assay and the predicate device, determined by Deming's Regression, is:
VITROS Folate assay =0.999 x Bio-Rad Quantaphase II Folate Radioassay + 0.676 ng/mL
Comparisons of the VITROS Folate assay and the predicate device were performed with samples from a variety of clinical categories.
Tests were performed to obtain analytical sensitivity, specificity, precision, dilution and expected values.
Comparison of VITROS Red Cell Folate assay to Predicate Device:
The relationship between the VITROS Red Cell Folate assay and the predicate device, determined by Deming's Regression, is:
VITROS Red Cell Folate assay =1.17 x Bio-Rad Quantaphase II Folate assay (used with the Bio-Rad Red Cell Folate Reagent Pack ) + 4.0 (ng/mL)
Comparisons of the VITROS Red Cell Folate assay and the predicate device were performed with samples from a variety of clinical categories.
Although there was a good correlation between the assays (r = 0.979), the VITROS assay showed an overall 17% positive bias. The results reflect true numerical differences for red cell folate measurement between the VITROS and Bio-Rad Quantaphase II assays.
Tests were performed to obtain precision, linearity and expected values.
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
§ 862.1295 Folic acid test system.
(a)
Identification. A folic acid test system is a device intended to measure the vitamin folic acid in plasma and serum. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia, which is characterized by the presence of megaloblasts (an abnormal red blood cell series) in the bone marrow.(b)
Classification. Class II.
0
510(k) Summary
(a) VITROS Folate assay
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: طبط / 1 / 984 / 1
1. Submitter name, address, contact Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive
Rochester, New York 14626-5101 (716) 453-3607
Contact Person: Anne Zavertnik
Date 510(k) prepared: November 18th, 1998
2. Device Name
(a) Folate assay
Trade or Proprietary Name: VITROS Immunodiagnostic Products Folate assay Common Name: Serum folate assay Classification Name: Folate assay for the in vitro quantitative measurement of folate in human serum and plasma (heparin).
3. Predicate Device
The VITROS Immunodiagnostic Products Folate assay is substantially equivalent to Bio-Rad Quantaphase II Folate Radioassay (K935286).
4. Device Description
The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum, plasma and urine. Coated microwells are used as the solid phase separation system.
VITROS Immunodiagnotic Products Folate Assay and Red Cell Folate Pack
1
The system is comprised of three main elements:
-
- The VITROS Immunodiagnostic Products range of products, in this case VITROS Immunodiagnostic Products Folate Reagent Pack, VITROS Immunodiagnostic Products Folate Calibrators and the VITROS Immunodiagnostic System. The VITROS Folate Reagent Pack consists of: The VITROS Immunodiagnostic Products Folate Reagent Pack 1/2 and the VITROS Immunodiagnostic Products Vitamin B12/Folate Reagent Pack 3
-
- The VITROS Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K962919).
-
- Common reagents used by the VITROS System in each assay. The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 510(k) pre-market notification (K984310).
The VITROS System and common reagents are dedicated specifically only for use with the VITROS Immunodiagnostic Products range of immunoassay products.
5. Device Intended Use
The VITROS Folate assay is intended for the in vitro quantitative measurement of folate in human serum and plasma (heparin) and whole blood (red cell folate), to aid in the differential diagnosis of anemia.
6. Comparison to Predicate Device
The VITROS Immunodiagnostic Products Folate assay is substantially equivalent to Bio-Rad Quantaphase II Folate Radioassay (predicate device), which was cleared by FDA (K935286) for IVD use.
The relationship between the VITROS Folate assay and the predicate device, determined by Deming's Regression, is:
VITROS Folate assay =0.999 x Bio-Rad Quantaphase II Folate Radioassay + 0.676 ng/mL Comparisons of the VITROS Folate assay and the predicate device were performed with samples from a variety of clinical categories.
2
In addition to the studies mentioned above, tests were performed to obtain analytical sensitivity, specificity, precision, dilution and expected values. Refer to the VITROS Folate assay package insert for VITROS Folate assay results.
Table 1 lists the similarities and differences of the device characteristics between the VITROS Folate assay with the predicate device, Bio-Rad Quantaphase II Folate Radioassay.
| Device
Characteristic | VITROS Folate assay | Predicate
Device |
|------------------------------------|-------------------------------------------------------|--------------------------------|
| Calibration range | 0 – 20 ng/ml | 0-20 ng/mL |
| Basic principle | Solid phase assay | Radioassay |
| Tracer | Enzyme labeled | 125Iodine |
| Instrumentation | VITROS
Immunodiagnostic System | Gamma Counter |
| Sample type | Serum, plasma (heparin) | Serum or plasma (EDTA) |
| Binding protein | Folate binding protein,
purified from bovine milk. | Folate binding protein |
| Sample volume | 53 µL | 200 µL |
| Incubation time and
temperature | 73 mins at 37 °C | 1 hour at room
temperature. |
Table 1 List of the assay characteristics
7. Conclusions
The data presented in the pre-market notification demonstrate that the VITROS Folate assay performs substantially equivalent to the predicate device, that was cleared by FDA (K935286) for IVD use.
Equivalence was demonstrated using currently commercially available reagents along with patient specimens covering a variety of clinical categories.
The data presented in the premarket notification provide a reasonable assurance that the VITROS Folate assay is safe and effective for the stated intended use.
3
(b) VITROS Red Cell Folate Pack
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: __________________
1. Submitter name, address, contact
Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101 (716) 453-3607
Contact Person: Anne Zavertnik
Date 510(k) prepared: November 18th, 1998
2. Device Name
Trade or Proprietary Name: VITROS Immunodiagnostic Products Red Cell Folate Pack (performed using the Vitros Folate Reagent Pack 1/2, VITROS Vitamin B12/Folate Reagent Pack 3 and the VITROS Red Cell Folate Pack)
Common Name: Red cell folate assay.
Classification Name: Red cell folate assay for the in vitro quantification of folate in human whole blood.
3. Predicate Device
The VITROS Immunodiagnostic Products Red Cell Folate assay, is substantially equivalent to Bio-Rad Quantaphase II Folate Radioassay used with the Bio-Rad Red Cell Folate Reagent Pack (K935286).
4. Device Description
The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum. plasma and urine. Coated microwells are used as the solid phase separation system.
The system is comprised of three main elements:
-
- The VITROS Immunodiagnostic Products (in this case VITROS Immunodiagnostic Products Red Cell Folate Pack, VITROS Immunodiagnostic Products Folate Pack 1/2, VITROS Immunodiagnostic Products Vitamin B12/Folate Reagent Pack 3, VITROS Immunodiagnostic Products Folate Calibrators, which are combined by the VITROS Immunodiagnostic System to perform the VITROS Red Cell Folate assay).
VITROS Immunodiagnotic Products Folate Assay and Red Cell Folate Pack
- The VITROS Immunodiagnostic Products (in this case VITROS Immunodiagnostic Products Red Cell Folate Pack, VITROS Immunodiagnostic Products Folate Pack 1/2, VITROS Immunodiagnostic Products Vitamin B12/Folate Reagent Pack 3, VITROS Immunodiagnostic Products Folate Calibrators, which are combined by the VITROS Immunodiagnostic System to perform the VITROS Red Cell Folate assay).
4
-
- The VITROS Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K962919).
-
- Common reagents used by the VITROS System in each assay. The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 510(k) pre-market notification (K984310).
The VITROS System and common reagents are dedicated specifically only for use with the VITROS Immunodiagnostic Products range of immunoassay products.
5. Device Intended Use
The Vitros Red Cell Folate Pack is intended for use in whole blood sample preparation to allow the in vitro quantitative measurement of red cell folate using the VITROS Immunodiagnostic System.
6. Comparison to Predicate Device
The VITROS Immunodiagnostic Products Red Cell Folate assay, is substantially equivalent to Bio-Rad Quantaphase II Folate Radioassay (predicate device), used with the Bio-Rad Red Cell Folate Reagent Pack, that was cleared by FDA (K935286) for IVD use.
The relationship between the VITROS Red Cell Folate assay and the predicate device, determined by Deming's Regression, is:
VITROS Red Cell Folate assay =1.17 x Bio-Rad Ouantaphase II Folate assay (used with the Bio-Rad Red Cell Folate Reagent Pack ) + 4.0 (ng/mL)
Comparisons of the VITROS Red Cell Folate assay and the predicate device were performed with samples from a variety of clinical categories.
Although there was a good correlation between the assays (r = 0.979), the VITROS assay showed an overall 17% positive bias. The results reflect true numerical differences for red cell folate measurement between the VITROS and Bio-Rad Quantaphase II assays.
In addition to the studies mentioned above, tests were performed to obtain precision, linearity and expected values. Refer to the VITROS Red Cell Folate Pack package insert for VITROS Red Cell Folate assay results.
Table 1 lists the similarities and differences of the device characteristics between the VITROS Red Cell Folate assay with the predicate device, Bio-Rad Quantaphase II Folate assay (used with the Bio-Rad Red Cell Folate Reagent Pack ).
5
| Table 1 List of the assay characteristics | |||||||
|---|---|---|---|---|---|---|---|
| -- | -- | -- | -- | -- | -- | -- | ------------------------------------------- |
| Device
Characteristic | VITROS Red Cell Folate
assay | Predicate
Device |
|------------------------------------|-------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Calibration range | 0 - 20 ng/ml | 0 - 20 ng/ml |
| Basic principle | Solid phase assay | Radioassay |
| Tracer | Enzyme labeled | 125I |
| Instrumentation | VITROS
Immunodiagnostic System | Gamma Counter |
| Sample type | Whole blood (EDTA or
heparin) | Whole blood (EDTA) |
| Binding Protein | Folate binding protein | Folate binding protein |
| Sample volume | 53 µL | 200 µL |
| Incubation time and
temperature | 90 minutes at room
temperature (whole blood
preparation); 73 minutes at
37° C (folate assay) | 90 minutes at room
temperature (whole blood
preparation); 60 minutes
at room temperature
(folate assay). |
7. Conclusions
The data presented in the pre-market notification demonstrate that the VITROS Red Cell Folate assay performs substantially equivalent to the predicate, that was cleared by FDA (K935286) for IVD use.
Equivalence was demonstrated using currently commercially available reagents along with patient specimens covering a variety of clinical categories.
The data presented in the premarket notification provide a reasonable assurance that the VITROS Red Cell Folate assay is safe and effective for the stated intended use.
6
Image /page/6/Picture/10 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" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure in profile, with three overlapping heads or faces.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 5 1999
Ms. Anne Zavertnik Regulatory Affairs Associate Ortho-Clinical Diagnostics A•Johnson & Johnson Company 100 Indigo Creek Drive Rochester, New York 14626-5101
Re: K984166 Trade Name: VITROS Immunodiagnostic Products Folate Assay Product Code: CGN Regulatory Class: II 118 II Dated: January 6, 1999 Received: January 7, 1999
Dear Ms. Zavertnik:
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 (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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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.
7
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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 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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 vours.
Steven Autman
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
8
Chapter 1 - Summary Information
Indications for Use Statement
Page 1 of 1
510(k) Number (if known)
.
{
| Device Name: | 1. VITROS Immunodiagnostic Products Folate Reagent Pack 1/2
2. VITROS Immunodiagnostic Products Vitamin B12/Folate Reagent
Pack 3
3. VITROS Immunodiagnostic Products Folate Calibrators |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 4. VITROS Immunodiagnostic Products Red Cell Folate Pack |
| Indications for Use: | 1. & 2. The VITROS Immunodiagnostic Products Folate Reagent Pack
1/2 and the VITROS Immunodiagnostic Products Vitamin B12/Folate
Reagent Pack 3 - for the in vitro quantitative measurement of folate in
human serum and plasma (heparin) and whole blood (red cell folate), to
aid in the differential diagnosis of anemia. |
| | 3. The VITROS Immunodiagnostic Products Folate Calibrators - for in vitro use in the calibration of the VITROS Immunodiagnostic System
for the quantitative measurement of folate in human serum and plasma
(heparin). |
| | 4. The VITROS Immunodiagnostic Products Red Cell Folate Pack - for
whole blood sample preparation, to allow the in vitro quantitative
measurement of red cell folate using the VITROS Immunodiagnostic
System. |
.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
| 510(k) Number | K 984166 |
|---|---|
| --------------- | ---------- |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| --------------------------------------- | ---- | ---------------------- |
(Optional Format 1-2-96)
l