(56 days)
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No
The document describes calibrators and performance verifiers for a chemistry system, which are standard laboratory reagents and controls. There is no mention of AI or ML in the intended use, device description, or any other section.
No
This device is for in vitro diagnostic use only, specifically for calibrating and monitoring the performance of a system that measures prealbumin, indicating it's a diagnostic tool, not a therapeutic one.
No
The device is a calibrator kit and performance verifiers used to monitor the performance of reagents on chemistry systems, not to diagnose a condition.
No
The device description clearly states it is a "liquid ready use kit" containing "processed human serum," "inorganic salts," "buffers," and "preservatives." These are physical components, not software.
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."
- Function: The device is used to calibrate and monitor the performance of a system that measures prealbumin quantitatively. This measurement is performed in vitro (outside the body) on biological samples (processed human serum).
- Components: The device consists of calibrators and performance verifiers, which are common components of IVD systems used to ensure the accuracy and reliability of diagnostic tests.
The description clearly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 23 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of prealbumin.
For in vitro diagnostic use only. VITROS Chemistry Products PALB Performance Verifiers are assayed controls used to monitor the performance of PALB Reagent on VITROS 5,1 FS Chemistry Systems.
Product codes (comma separated list FDA assigned to the subject device)
JIT, JJX
Device Description
VITROS Chemistry Products Calibrator Kit 23
VITROS Chemistry Products Calibrator Kit 23 is a liquid ready use kit containing five levels for the calibration of VITROS 5,1 FS Chemistry Systems for the quantitative measurement of prealbumin.
These calibrators are prepared from processed human serum to which inorganic salts, buffers, and preservatives have been added.
VITROS Chemistry Products PALB Performance Verifiers I and II
VITROS Chemistry Products PALB Performance Verifiers contain two levels of liquid ready to use assayed controls for use in monitoring performance of PALB Reagents on VITROS 5,1 FS Chemistry Systems.
These controls are prepared from processed human serum to which inorganic salt, buffers and preservative have been added.
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
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Indicated Patient Age Range
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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.
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DEC - 9 2004
Image /page/0/Picture/1 description: The image shows a sequence of alphanumeric characters, specifically 'K042838'. The characters are written in a bold, sans-serif font, and they appear to be handwritten. The numbers are easily readable, and the 'K' is distinct.
3.0 510(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.
and the comments of the comments of the comments of the comments of the contraction of the contribution of the contribution of the contribution of the contribution of the con
The assigned 510(k) number is:
Submitter name, address, contact 3.1
Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101 Phone: (585) 453-4253 Fax: (585) 453-3368
Contact Person: Darlene J. Phillips
3.2 Date of Preparation:
October 13, 2004
3.3 Device Proprietary Names:
| Trade Names | VITROS Chemistry Products Calibrator Kit 23
VITROS Chemistry Products PALB Performance Verifier I and II |
|-------------|-------------------------------------------------------------------------------------------------------------|
| Common Name | Prealbumin calibrator and controls |
の 2007年の1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には1000年に1000
3.4 Classification Names
Classification Name: Calibrator (862.1150): Class II The Clinical Chemistry and Toxicology Panel of the FDA has placed calibrators in Class II.
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.
3.5 Predicate devices
The VITROS Chemistry Products Calibrator Kit 23 and VITROS Chemistry Products PALB Performance Verifiers are substantially equivalent to the VITROS Chemistry Products Calibrator Kit 17 and VITROS Chemistry Products hsCRP Performance Verifiers, respectively. The predicate devices were cleared by FDA (K041799) for IVD use.
1
3.6 Device description
VITROS Chemistry Products Calibrator Kit 23
VITROS Chemistry Products Calibrator Kit 23 is a liquid ready use kit containing five levels for the calibration of VITROS 5,1 FS Chemistry Systems for the quantitative measurement of prealbumin.
These calibrators are prepared from processed human serum to which inorganic salts, buffers, and preservatives have been added.
VITROS Chemistry Products PALB Performance Verifiers I and II
VITROS Chemistry Products PALB Performance Verifiers contain two levels of liquid ready to use assayed controls for use in monitoring performance of PALB Reagents on VITROS 5,1 FS Chemistry Systems.
These controls are prepared from processed human serum to which inorganic salt, buffers and preservative have been added.
3.7 Device intended use
VITROS Chemistry Products Calibrator Kit 23
For in vitro diagnostic use only
VITROS Chemistry Products Calibrator Kit 23 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of prealbumin.
VITROS Chemistry Products PALB Performance Verifiers I and II
For in vitro diagnostic use only
VITROS Chemistry Products PALB Performance Verifiers are assayed controls used to monitor the performance of PALB Reagent on VITROS 5,1 FS Chemistry Systems.
3.8 Comparison to predicate device
The VITROS Chemistry Products Calibrator Kit 23 and VITROS Chemistry Products PALB Performance Verifiers are substantially equivalent to the VITROS Chemistry Products Calibrator Kit 17 and VITROS Chemistry Products hsCRP Performance Verifiers, respectively. The predicate devices were cleared by the FDA (K041799) for IVD use,
Tables 1 and 2 provide similarities and differences between the new devices and predicate devices.
Continued on next page
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- Table 1 lists the similarities and differences of the device characteristics between new device, Table 1 VITROS Chemistry Products Calibrator Kit 23 and predicate device, VITROS Chemistry Products Calibrator Kit 17.
| Device
Characteristic | VITROS Calibrator Kit 23
New device | VITROS Calibrator Kit 17
Predicate device |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For in vitro diagnostic use only.
VITROS Chemistry Products
Calibrator Kit 23 is used to calibrate
VITROS 5,1 FS Chemistry Systems
for the quantitative measurement of
prealbumin (PALB). | For in vitro diagnostic use only.
VITROS Chemistry Products Calibrator
Kit 17 is used in conjunction with
VITROS Chemistry Products FS
Calibrator 1 to calibrate VITROS 5,1 FS
Chemistry Systems for the quantitative
measurement of C-reactive protein (CRP
using VITROS hsCRP Reagent. |
| Fluid Matrix | A base matrix of processed human
serum to which inorganic salts,
buffers, and preservatives have been
added. | A base matrix of stabilized human serum
to which analytes and preservatives have
been added |
| Analyte Levels | Five levels | Single level |
| Analyte | Prealbumin (transthyretin) | C-reactive protein |
| Traceability | CRM470 | Same |
| Format | Liquid ready to use | Same |
Table 2 Table 2 lists the similarities and differences of the device characteristics between new device, VITROS PALB Performance Verifiers and predicate device, VITROS hsCRP Performance Verifiers
| Device
Characteristic | VITROS PALB Performance
Verifiers
New device#2 | VITROS hsCRP Performance
Verifiers
Predicate device#2 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For in vitro diagnostic use only.
VITROS Chemistry Products PALB
Performance Verifiers are assayed
controls used to monitor the
performance of PALB Reagent on
VITROS 5,1 FS Chemistry Systems. | For in vitro diagnostic use only. VITROS
Chemistry Products hsCRP Performance
Verifiers are assayed controls used to
monitor performance of hsCRP Reagent
on VITROS 5,1 FS Chemistry Systems. |
| Fluid Matrix | A base matrix of processed human
serum to which inorganic salt,
buffers and preservative have been
added. | A base matrix of human plasma and
plasma proteins to which stabilizers and
preservative have been added. |
| Analyte Levels | Low and High | Low, Medium and High |
| Analyte | Prealbumin (transthyretin) | C-reactive protein |
| Format | Liquid ready to use | Same |
Continued on next page
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" surrounding the top half of the circle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC - 9 2004
Ms. Darlene J. Phillips, RAC Regulatory Affairs Associate Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, NY 14626
K042838 Re:
Trade/Device Name: VITROS Chemistry Products Calibrator Kit 23 · VITROS Chemistry Products PALB Performance Verifiers I and II Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT, JJX Dated: October 13, 2004 Received: October 14, 2004
Dear Ms. Phillips:
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. Iisting 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 (OS) regulation (21 CFR Part 820).
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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,
Cornelia B. Lorks
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
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1.0 Indications for Use
| 510(k) Number
| (if known): | K042838 | ||
|---|---|---|---|
| Device Name: | VITROS Chemistry Products Calibrator Kit 23 | ||
| VITROS Chemistry Products PALB Performance Verifiers I and II | |||
| Indications for Use: | For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit | ||
| 23 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative | |||
| measurement of prealbumin. |
For in vitro diagnostic use only. VITROS Chemistry Products PALB
Performance Verifiers are assayed controls used to monitor the performance
of PALB Reagent on VITROS 5,1 FS Chemistry Systems. | | |
| Prescription Use | X | AND/OR | Over-The-Counter Use |
| (Part 21 CFR 801 Subpart D) | | (21 CFR 807 Subpart C) | |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IFNEEDED)
:
Concurrence of CDRH, Office of Device Evaluation (ODE)
Carol Benson
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K042838
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