(135 days)
No
The document describes an in vitro diagnostic control material and the associated instrumentation system, with no mention of AI or ML technologies in the intended use, device description, or other sections.
No
This device is described as an "assayed control" used for in vitro monitoring of an immunodiagnostic system, not for treating any condition in a patient.
No
Explanation: The device described, "Assayed controls," is an in vitro control used to monitor the performance of an immunodiagnostic system. It is not itself a diagnostic device, but rather a control for another diagnostic device (the VITROS Immunodiagnostic System).
No
The device description clearly outlines a system comprised of physical components: reagent packs, instrumentation, and common reagents. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for in vitro use in monitoring the performance of the VITROS Immunodiagnostic System". This indicates the device is used outside of the body to assess the function of another diagnostic system.
- Device Description: The description details a system that uses "human body fluids, commonly serum" for the "determination of selected analytics". This is a hallmark of in vitro diagnostics.
- Predicate Device: The predicate device listed (Bio-Rad Lyphochek® Immunoassay Plus Control 1, 2 and 3) is also a control material used in immunoassay testing, which falls under the category of IVDs.
The device is a control material used to ensure the accuracy and reliability of an immunoassay system, which itself is an IVD. Control materials used in this context are considered IVDs.
N/A
Intended Use / Indications for Use
The VITROS Anemia Controls are intended for in vitro use in montoring the performance of the VITROS Immunodiagnostic System when used for the measurement of selected analytes.
Assayed controls for in vitro use in monitoring the performance of the VITROS Immunodiagnostic System when used for the measurement of the analytes listed in this package insert (ferritin, folate, and vitamin B12).
Product codes
JJY
Device Description
The VITROS Immunodiagnosue System ases in human body fluids, commonly serum. semi-quantitative determination of selected analytics and statem semi-quantitative determination of hersen in the solid phase separation system.
The system is comprised of three main elements:
-
- The VITROS Immunodiagnostic Products range of products in this case VITROS The VTROS Immunodiagnostic Products fallge of -propriments Products Calibrators Immunodiagnostic Products Reagent Pack, VITROS Immunodiagnostic Products assay Immunodiagnostic Products Reagent Fack, PFFNAS stices stic System to perform a VITROS assay. which are combined by the VITROS Immunodiagnostic System to perform a VITROS ass
-
- The VITROS Immunodiagnostic System instrumentation, which provides automatical use of The VITROS Immunodiagnostic System - matimemation, Microp the immunoassay kits. The VITROS Immodiagnostic System was cleared for market by a reas and the VITROS Imments on 11 the immunoussay komarket notification (K962919).
-
- Common reagents used by the VTROS System in each assay. The VTROS Immundiagnostic Same of the VTROS System in and in and in Products Universal Wash Rauent Common reagent and VITROS Immunodiagnostic Products Universal Wash Reagent Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Products Signal Products Signal Reagent and VITROS Immunodiagnostic Products Total T3 510(k) pre-market were cleared as part of the VITROS Immunodiagnostic Products Total T3 510(k) pre-marke notification (K964310).
The VITROS System and common reagents are dedicated specifically only for use with the The VITROS System and commond 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are 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 heing submitted in accordance with
t accordance of the 1948 - 1 21 CVD 807 92 This summary of 910(K) safety safety safety of CFR 807.92
The assigned 510(k) number is: 49900 12-
1. Submitter name, address, contact
Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101 (716) 453-3790
Contact Person: Anne Zavertnik
Date 510(k) prepared: December 31, 1998
Device Name 2.
Trade or Proprietary Name: VITROS Immunodiagnostic Products Anemia Controls Common Name: Anemia controls Common Name: Anemia controls
Classification Name: 21CFR 862.1660 Quality Control Material (Assayed and Unassayed)..
3. Predicate Device
- Predicate Device
The VITROS Immunodiagnostic Products Anemia controls are substantially equivalent to Bio-Rad The VTTROS Immunodiagnestic Production 1, 2 and 3 (K981532).
4. Device Description
- Device Description The VIIROS Immunodiagnosue System ases in human body fluids, commonly serum.
semi-quantitative determination of selected analytics and statem semi-quantitative determination of hersen in the solid phase separation system.
The system is comprised of three main elements:
-
- The VITROS Immunodiagnostic Products range of products in this case VITROS The VTROS Immunodiagnostic Products fallge of -propriments Products Calibrators
Immunodiagnostic Products Reagent Pack, VITROS Immunodiagnostic Products assay Immunodiagnostic Products Reagent Fack, PFFNAS stices stic System to perform a VITROS assay.
which are combined by the VITROS Immunodiagnostic System to perform a VITROS ass
- The VITROS Immunodiagnostic Products range of products in this case VITROS The VTROS Immunodiagnostic Products fallge of -propriments Products Calibrators
1
510(k) Summary, continued.
-
- The VITROS Immunodiagnostic System instrumentation, which provides automatical use of The VITROS Immunodiagnostic System - matimemation, Microp
the immunoassay kits. The VITROS Immodiagnostic System was cleared for market by a
reas and the VITROS Imments on 11 the immunoussay komarket notification (K962919).
- The VITROS Immunodiagnostic System instrumentation, which provides automatical use of The VITROS Immunodiagnostic System - matimemation, Microp
-
- Common reagents used by the VTROS System in each assay. The VTROS Immundiagnostic
Same of the VTROS System in and in and in Products Universal Wash Rauent Common reagent and VITROS Immunodiagnostic Products Universal Wash Reagent
Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Products Signal Products Signal Reagent and VITROS Immunodiagnostic Products Total T3 510(k) pre-market
were cleared as part of the VITROS Immunodiagnostic Products Total T3 510(k) pre-marke notification (K964310).
- Common reagents used by the VTROS System in each assay. The VTROS Immundiagnostic
The VITROS System and common reagents are dedicated specifically only for use with the The VITROS System and commond of immunoassay products.
5. Device Intended Use
- Device Intended Use
The VITROS Anemia Controls are intended for in vitro use in montoring the performance of the The VITROS Anemia Controls are michded for the measurement of selected analytes.
VITROS Immunodiagnostic System when used for the measurement of selected analytes.
6. Comparison to Predicate Device
- Comparison to Predicate Device
The VITROS Immunodiagnostic Products Anemia Controls is substantially equivalent to Bio-Rad The VTROS Immunodiagnosuc Froducts Anema Comicolor of chared by FDA (K981532)
Lyphochck® Immunoassay Plus Control 1.cvels 1. 2 and 3 which was cleared by FDA (K981532) for IVD use.
Table 1 lists the similarities and differences of the device characteristics between the VITROS Anemia Controls and the predicate device.
Table 1 List of the controls characteristics
| Characteristics | New Device | Predicate Device |
|---|---|---|
| Intended use | For use in monitoring | |
| the performance of the | ||
| VITROS System when | ||
| used for the | ||
| measurement of | ||
| selected analytes | For use as an assayed | |
| quality control serum to | ||
| monitor the precision of | ||
| laboratory testing | ||
| procedures | ||
| Matrix of controls | Composed of buffer | |
| and horse serum, spiked | ||
| with different analytes | ||
| to achieve the required | ||
| levels | Human serum with | |
| added constituents of | ||
| human origin and pure | ||
| chemicals | ||
| Control levels | Low, medium and high | Low, medium and high |
2
510(k) Summary, continued.
Table 1, (continued)
| Characteristics | New Device | Predicate Device |
|---|---|---|
| Expected values | Each control has quoted | |
| for each specific analyte | ||
| a mean value derived | ||
| from a minimum of 10 | ||
| assays and a standard | ||
| deviation anticipated | ||
| for singleton | ||
| determinations of each | ||
| control in a number of | ||
| different laboratories | ||
| using different reagent | ||
| batches. Values are lot | ||
| specific. | The mean values and | |
| acceptable ranges | ||
| printed in the insert | ||
| were derived from | ||
| replicate analyses and | ||
| are specific for this lot | ||
| of Bio-Rad | ||
| Lyphochek® | ||
| Immunoassay Plus | ||
| Control Levels 1, 2 and |
- The tests listed were
performed by the
reagent manufacturer
and/or independent
laboratories using
manufacturer supported
reagents and a
representative sampling
of this control lot. |
7. Conclusions
The data presented in the pre-market notification demonstrate that the VITROS Anemia The data presented in the pre-marine the predicate device Bio-Rad Lynhochek®
Controls are substantially equivalent to the prodicate device Bio-Rad by EDA (K981532) Controls are substantinly equivatent to the predicate accessed by FDA (K981532) for IVD use.
The data presented in the premarket notification provide a reasonable assurance that the I he uata prescined in the promises
VITROS Anemia Controls are safe and effective for the stated intended use.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows a circular logo for the Department of Health & Human Services - USA. The logo features the department's name in a circular arrangement around an emblem. The emblem consists of a stylized representation of what appears to be a human figure or symbol, with three lines extending upwards and to the right.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 21 1999
Ms. Anne Zavertnik Regulatory Affairs Associate Ortho-Clinical Diagnostics A Johnson & Johnson Company 100 Indigo Creek Drive Rochester, New York 14626-5101
K990016 Re: K990016
Trade Name: VITROS Immunodiagnostic Products Anemia Controls Regulatory Class: I Product Code: JJY Dated: March 26, 1999 Received: March 31, 1999
Dear Ms. Zavertnik:
This corrects the letter dated May 19, 1999 where the incorrect K#, K99016, was referenced I his corrects the referen dated way of intent to market the device referenced We have reviewed your Scellon >10(x) notifically equivalent (for the indications for use above and we nave delemined the devices sedicate devices marketed in interstate commerce stated in the enclosure) to legally marked processor is a local mendments, or to devices that prior to May 26, 1970, the chaement atte of the Federal Food, Drug, and Cosmetic
have been reclassified in accordance with the provisions of controls provisions of Act (Act). You may, therefore, market the device, subject to the general controls provisions of Act (Act). You may, therefore, market the device, casifiements for annual registration, the Act. The general contrins provisions of the free models of the models and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III If your device is classined (see above) into entil additional controls. Existing major regulations. (Premarket Approval), it may be sunject to such additional Regulations, Times 800 to 895.
affecting your device can be found in the Code of Federal Regulations, Times 800 to A substantially equivalent determination assumes compliance with the Current Good A substantially equivalent determination assames in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS
Medical Devices: General regulation (21 CFR Part 820) and that, the martiens of inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to inspections, the Food and Drug Administration (1717) was vion, In addition, FDA may publish
comply with the GMP regulation may result in regulation in crian Plasse note: comply with the GMF Tegulation in regulation in regards offect one obligation you mi turther announcements concerning your uchosen and affect any obligation you might have
response to your premarket notification submission of a filestrania Product Ragiation response to your prematics nomication submission access the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
4
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLA-88), this device may
15 the Under the Clinical Laboratory Improvenient Aniences of to does, you should contact the
require a CLIA complexity categorization. To determine if it does, you should contact require a CLIA complexity Categorized (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 510(k) premarket This letter will allow you to begilt marketing your device of your device to a legally marketed
notification. The FDA finding of substantial equivales and the permits your d notification. The FITA finding of substantial equivaled of 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 If you desire specific advice for your devices), please contact the Office of Compliance at
additionally 809.10 for in vitro diagnostic devices), please contact the office of additionally 809.10 for in viro diagnosions on the promotion and advertising of your device, (301) 594-4588. Additionally, for questions of the pressence the regulation please contact the Office of Compliation of (30) - 7721 CFR 807.97). Other general
entitled, "Misbranding by reference to premarks antinentification fight of Small entitled, "Misbranding by reterence openialser may be obtaind (in Bironthe Division of Small
information on your responsibilities under the Act may be obtains of Small information on your responsibilities under (800) 638-2041 or (301) 443-6597, or at its
Manufacturers Assistance at its toll-free number (800) 638-6597, or at its
entify of Mainufacturers 7155f5tan100 av 1da.gov/cdrh/dsma/dsmamain.html".
internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
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
5
Statement of Intended Use
Page 1 of 1
| 510(k) Number (if known): | |
|---|---|
| Device Name: | VITROS Immunodiagnostic Products Anemia Controls |
| Indications for Use: | Assayed controls for in vitro use in monitoring the performance of the VITROS Immunodiagnostic System when used for the measurement of the analytes listed in this package insert (ferritin, folate, and vitamin B12). |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF
NEFFECT NEFF - NEEDED) 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) | |
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K990016 |
510(k) Number .
.