(18 days)
Not Found
No
The device description and intended use are for calibrators and performance verifiers for a chemistry system, which are standard laboratory reagents and controls. There is no mention of AI, ML, or any computational analysis beyond standard quantitative measurements.
No.
This device is an in vitro diagnostic (IVD) product used for calibrating and monitoring the performance of chemistry systems that measure proteins in body fluids; it is not directly applied to a patient for therapeutic purposes.
No
The device is a calibrator kit and performance verifiers used to calibrate and monitor the performance of chemistry systems, not to diagnose a condition directly. It is explicitly stated that it is for "in vitro diagnostic use only", but "diagnostic use" in this context refers to its role in aiding a system that performs diagnostics, not as a diagnostic device itself.
No
The device description clearly states the device is a "five level set of fluids" and a "three level set of assayed liquid controls," indicating it is a physical product (calibrators and controls) used in conjunction with a chemistry system, not a software-only device.
Yes, based on the provided text, 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." This is the most direct indicator.
- Function: The device is used to calibrate and monitor the performance of systems that measure proteins in body fluids. This is a typical function of IVD devices, which are used to examine specimens taken from the human body to provide information for diagnostic purposes.
- Device Description: The description details the composition of the calibrator and verifiers, which are prepared from processed human serum. This further supports its use in laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 99 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of proteins in body fluids.
For in vitro diagnostic use only. VITROS Chemistry Products AAT/HPT Performance Verifiers are assayed controls used to monitor the performance of protein measurements in body fluids on VITROS 5,1 FS Chemistry Systems.
Product codes (comma separated list FDA assigned to the subject device)
JIX, JJX
Device Description
VITROS Chemistry Products Calibrator Kit 99
VITROS Chemistry Products Calibrator Kit 99 is a five level set of fluids used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of 0,1-antitrypsin (AAT), and haptoglobin (HPT) using VITROS Chemistry Products AAT and HPT Reagents. VITROS Chemistry Products Calibrator Kit 99 is prepared from processed human serum to which inorganic salts, buffers, and preservatives have been added.
VITROS Chemistry Products AAT/HPT Performance Verifiers I, II, and III
VITROS Chemistry Products AAT/HPT Performance Verifiers I, II, and III is a three level set of assayed liquid controls used to monitor the performance of cx1-antitrypsin (AAT), and haptoglobin (HPT) measurements, using VITROS Chemistry Products AAT and HPT Reagents, respectively, with the VITROS 5,1 FS Chemistry Systems. The VITROS AAT/HPT Performance Verifiers are prepared from processed human serum to which inorganic salts, buffers, and preservatives have been added.
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): 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.
Not Found
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
5.0 510(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: 1000000
Submitter name, address, contact 5.1
Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester. New York 14626-5101 Telephone: (585) 453- 4041 Facsimile: (585) 453-3368 Contact Person: Marlene Hanna
Date of Preparation: April 5, 2006 5.2
Device Proprietary Names: 5.3
VITROS Chemistry Products Calibrator Kit 99 Trade Names:
VITROS Chemistry Products AAT/HPT Performance Verifier I, II, and III
Common Name: Calibrators and controls
5.4 Classification Names
Classification Name: Calibrator (21 CFR 862.1150): Class II
Classification Name: Quality Control material (assayed and unassayed) (21 CFR 862.1660): Class I: Reserved
Predicate devices 5.5
The VITROS Chemistry Products Calibrator Kit 99 (new intended use), and VITROS Chemistry Products AAT/HPT Performance Verifiers I, II, and III are substantially equivalent to the VITROS Chemistry Products Calibrator Kit 99 (current product), and VITROS Chemistry Products AAT Performance Verifiers I, II, and III respectively. The predicate devices were both previously cleared by the FDA (K052819) for IVD use.
1
5.6 Device description
VITROS Chemistry Products Calibrator Kit 99
VITROS Chemistry Products Calibrator Kit 99 is a five level set of fluids used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of 0,1-antitrypsin (AAT), and haptoglobin (HPT) using VITROS Chemistry Products AAT and HPT Reagents. VITROS Chemistry Products Calibrator Kit 99 is prepared from processed human serum to which inorganic salts, buffers, and preservatives have been added.
VITROS Chemistry Products AAT/HPT Performance Verifiers I, II, and III
VITROS Chemistry Products AAT/HPT Performance Verifiers I, II, and III is a three level set of assayed liquid controls used to monitor the performance of cx1-antitrypsin (AAT), and haptoglobin (HPT) measurements, using VITROS Chemistry Products AAT and HPT Reagents, respectively, with the VITROS 5,1 FS Chemistry Systems. The VITROS AAT/HPT Performance Verifiers are prepared from processed human serum to which inorganic salts, buffers, and preservatives have been added.
5.7 Device intended use
VITROS Chemistry Products Calibrator Kit 99
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 99 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of proteins in body fluids.
VITROS Chemistry Products AAT/HPT Performance Verifier I, II, and III For in vitro diagnostic use only. VITROS Chemistry Products AAT/HPT Performance Verifiers are assayed controls used to monitor the performance of protein measurements in body fluids on VITROS 5,1 FS Chemistry Systems.
Continued on next page
2
Comparison to predicate device 5.8
The VITROS Chemistry Products Calibrator Kit 99 (new intended use), and VITROS Chemistry Products AAT/HPT Performance Verifiers I, II, and III are substantially equivalent to the VITROS Chemistry Products Calibrator Kit 99 (current product), and VITROS Chemistry Products AAT Performance Verifiers I, II and III, respectively. The predicate devices were both previously cleared by the FDA (K052819) for IVD use.
Tables 1 and 2 provide similarities and differences between the new devices and predicate devices.
Table 1 lists the similarities and differences of the device characteristics between new device VITROS Chemistry Products Calibrator Kit 99 (new intended use) and predicate device, VITROS Chemistry Products Calibrator Kit 99 (current Product).
TABLE 1
| Device | VITROS Calibrator Kit 99 | VITROS Calibrator Kit 99 |
|---|---|---|
| Characteristic | (New intended use) | |
| New Device#1 | (Current Product) | |
| Predicate Device#1 | ||
| Intended Use | ||
| Statement | For in vitro diagnostic use only. | |
| VITROS Chemistry Products | ||
| Calibrator Kit 99 is used to | ||
| calibrate VITROS 5,1 FS | ||
| Chemistry Systems for the | ||
| quantitative measurement of | ||
| proteins in body fluids. | For in vitro diagnostic use only. | |
| VITROS Chemistry Products | ||
| Calibrator Kit 99 is used to | ||
| calibrate VITROS 5,1 FS | ||
| Chemistry Systems for the | ||
| quantitative measurement of α1- | ||
| antitrypsin (AAT). | ||
| Analytes | α₁-Antitrypsin(AAT), | |
| Haptoglobin (HPT) | α₁-Antitrypsin (AAT) | |
| Traceability | BAM-IRMM-LGC | |
| (Bundesanstalt für | ||
| Materialforschung und -prüfung / | ||
| Institute for Reference Methods | ||
| and Materials / Laboratory of the | ||
| Government Chemist) ERM- | ||
| DA470 Reference Material¹ | BAM-IRMM-LGC | |
| (Bundesanstalt für | ||
| Materialforschung und -prüfung / | ||
| Institute for Reference Methods | ||
| and Materials / Laboratory of the | ||
| Government Chemist) ERM- | ||
| DA470 Reference Material¹ | ||
| Number of levels | Five | Five |
| Format | Liquid ready to use | Liquid ready to use |
| Fluid Matrix | Processed human serum | Processed human serum |
Continued on next page
3
Table 2 lists the similarities and differences of the device characteristics between new device VITROS AAT/HPT Performance Verifiers and predicate device, VITROS AAT Performance Verifiers.
| Device
Characteristic | VITROS AAT/HPT Performance
Verifiers I, II and III
New device #2 | VITROS AAT Performance
Verifiers I, II, and III
Predicate device #2 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use
Statement | For in vitro diagnostic use only.
VITROS Chemistry Products
AAT/HPT Performance Verifiers
are assayed controls used to
monitor performance of protein
measurements in body fluids with
VITROS 5,1 FS Chemistry
Systems. | For in vitro diagnostic use only.
VITROS Chemistry Products
AAT Performance Verifiers are
assayed controls used to
monitor performance of
VITROS AAT Reagents on
VITROS 5,1 FS Chemistry
Systems. |
| Analytes | α₁-Antitrypsin(AAT), Haptoglobin
(HPT) | α₁-Antitrypsin (AAT) |
| Number of
levels | Three | Three |
| Format | Liquid ready to use | Liquid ready to use |
| Fluid Matrix | Prepared from processed human
serum to which inorganic salts,
buffers, and preservatives have
been added. | Prepared from processed human
serum to which inorganic salts,
buffers, and preservatives have
been added. |
ર . 9 Conclusions
The information presented in this premarket notification provide a reasonable assurance that the VITROS Chemistry Products Calibrator Kit 99 and the VITROS Chemistry Products AAT/HPT Performance Verifiers I, II and III are safe and effective for the stated intended uses.
Ortho-Clinical Diagnostics, Inc. believes that the VITROS Chemistry Products Calibrator Kit 99 (new intended use), and VITROS Chemistry Products AAT/HPT Performance Verifiers I, II, and III are substantially equivalent to the VITROS Chemistry Products Calibrator Kit 99 (current product), and VITROS Chemistry Products AAT Performance Verifiers I, II, and III respectively. The predicate devices were both previously cleared by the FDA (K052819) for IVD use.
4
Image /page/4/Picture/1 description: The image shows a black and white logo. The logo is a circular seal with text around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the right.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 2 4 2006
Ortho-Clinical Diagnostics, Inc. c/o Ms. Marlenc Hanna Regulatory Affairs Manager 100 Indigo Creek Dr. Rochester, NY 14626-5101
Rc: K060940
Trade/Device Name: VITROS Chemistry Products Calibrator Kit 99 VITROS Chemistry Products AAT/HPT Performance Verifier I, II and III Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX, JJX Dated: April 5, 2006 Received: April 6, 2006
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 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): good manufacturing practice requirements as set forth in the quality systems (QS) requlation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
5
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FI>A 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), please contact the Office of Compliance at (240) 276-0484. 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/industry/support/index.html.
Sincerely yours,
Zohut H. Becker/
Robert I .. Becker, Jr., M.D/, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
4.0 Indications for Use Statement
_ . . . . . . ________________________________________________________________________________________________________________________________________________________________
| 510(k) Number
| (if known): | K060940 |
|---|---|
| Device Name: | VITROS Chemistry Products Calibrator Kit 99 |
| VITROS Chemistry Products AAT/HPT Performance Verifier I, II, and III | |
| Indications for Use: | For in vitro diagnostic use only. |
| VITROS Chemistry Products Calibrator Kit 99 is used to calibrate VITROS | |
| 5,1 FS Chemistry Systems for the quantitative measurement of proteins | |
| in body fluids. |
For in vitro diagnostic use only.
VITROS Chemistry Products AAT/HPT Performance Verifiers are assayed
controls used to monitor the performance of protein measurements in
body fluids on VITROS 5,1 FS Chemistry Systems. |
Over-The-Counter Use AND/OR Prescription Use ど (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
______________________________________________________________________________________________________________________________________________________________________________ Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
ina Den
Division Sim-Off
Lavision Sign-Off
__. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
।
Office of In Vitro Diagnostic Device Evaluction and Safety
Ks 60745
。 ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・