(52 days)
Not Found
Not Found
No
The summary describes a calibrator and control set for a prealbumin test system, which are standard laboratory reagents and do not indicate the use of AI/ML. There are no mentions of AI, ML, image processing, or data analysis methods typically associated with AI/ML.
No
The device is a calibrator and control set used for diagnostic testing of prealbumin levels, not for treating any medical condition.
No
The Wako Prealbumin Calibrator Set and Control Set are intended to establish points of reference for the measurement of prealbumin and to estimate test precision respectively. They are used within a larger test system and do not, on their own, diagnose a condition.
No
The device is a calibrator and control set, which are physical reagents used in a laboratory test system, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "establish points of reference that are to be used in determination of values in the measurement of prealbumin in human serum or plasma." This involves testing biological samples (serum or plasma) in vitro (outside the body) to obtain diagnostic information (prealbumin levels).
- Control Set: The inclusion of a "Control Set" further supports its IVD nature, as controls are essential for ensuring the accuracy and reliability of in vitro diagnostic tests.
The description aligns perfectly with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
The Wako Prealbumin Calibrator Set is intended to be used in the Wako Prealbumin Test System to establish points of reference that are to be used in determination of values in the measurement of prealbumin in human serum or plasma.
The Wako Prealbumin Control Set is intended to be used in the Wako Prealbumin Test System to estimate test precision and detect systematic analytical deviations that may arise from reagent or analytical instrument variation.
Product codes
JIT, JJX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human serum or plasma
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in a simple, bold line drawing.
MAR 2 5 2004
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Lori Creasy Regulatory Affairs Specialist Wako Chemicals, USA, Inc. 1600 Bellwood Road Richmond, VA 23237
K040226 Re:
Trade/Device Name: Wako Prealbumin Calibrator Set Wako Prealbumin Control Set Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT, JJX Dated: January 29, 2004 Received: February 9, 2004
Dear Ms. Creasy .:
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).
1
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 vours.
Jean M. Cooper, MS, DVM.
Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
Indications for Use
K040226 510(k) Number (if known):
Wako Prealbumin Calibrator Set Device Name:
Indications For Use:
The Wako Prealbumin Calibrator Set is intended to be used in the Wako Prealbumin Test System to establish points of reference that are to be used in determination of values in the measurement of prealbumin in human serum or plasma.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use N/A (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C Benson
Division Sign-Off
Division Sign-
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K040226
Page 1 of __
3
Indications for Use
K040226 510(k) Number (if known):
Wako Prealbumin Control Set Device Name:
Indications For Use:
The Wako Prealbumin Control Set is intended to be used in the Wako Prealbumin Test System to estimate test precision and detect systematic analytical deviations that may arise from reagent or analytical instrument variation.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use __ N/A (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C Benson
Division Sign Off
Division Sign-Off
Office of in Vitro Diagnostic Device Evaluation and Safety
510(k) Koyozzb
Page of 2