(57 days)
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No
The document describes a chemical calibrator for laboratory assays, with no mention of AI or ML technology.
No
The device is a calibrator used with assays to determine various chemical levels in human serum, which is for diagnostic purposes, not therapeutic intervention.
Yes
The device is used to "determine" levels of various substances (Calcium, FE, UIBC, Inorganic Phosphorus and Magnesium) in human serum, which is a common function of diagnostic devices for assessing a patient's health status.
No
The 510(k) summary describes a "Multi-Chem Calibrator A," which is a substance used with assays to determine the concentration of various chemicals in human serum. This is a chemical reagent, not a software device. The summary lacks any mention of software, algorithms, or digital processing.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the Multi-Chem Calibrator A is "designed to be used with Wako's assays to determine... Calcium, FE, UIBC, Inorganic Phosphorus and Magnesium in human serum."
- Human Specimen: The device is used to analyze components in human serum, which is a biological specimen.
- Diagnostic Purpose: While the calibrator itself doesn't directly diagnose a condition, it is an essential component used with assays that are intended for diagnostic purposes (determining levels of substances in human serum). Calibrators are used to ensure the accuracy of these diagnostic assays.
Therefore, the Multi-Chem Calibrator A fits the definition of an In Vitro Diagnostic device because it is used in vitro (outside the body) to examine a human specimen (serum) for the purpose of providing information that can be used in a diagnostic context.
N/A
Intended Use / Indications for Use
The Multi-Chem Calibrator A is designed to be used with Wako’s assays to betermine The Multi-Offern Oulibratel free used in the determination of Calcium, FE, UIBC, Inorganic Phosphorus and Magnesium in human serum.
Product codes
JIX
Device Description
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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
Prescription Use (Part 21 CFR 801 Subpart D)
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
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The caduceus is depicted with three flowing lines, representing the snakes, and the text is in a simple, sans-serif font.
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
NOV 1 6 2004
Re: K042551 Trade/Device Name: Multi-Chem Calibrator A Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: August 26, 2004 Received: September 21, 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).
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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin marketing of substantial equivalence of your device to a legally prematication. The PDF interessification 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, If you destions on the promotion and advertising of your device, please contact the Office of of questions on the promotion and Safety at (301) 594-3084. Also, please note the m Puro Diagins Do Hovending by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Tou may oodain other general mormational 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,
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
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K042551 510(k) Number (if known):
Device Name: Multi-Chem Calibrator A
Indications For Use:
The Multi-Chem Calibrator A is designed to be used with Wako's assays to betermine The Multi-Offern Oulibratel free used in the determination of Calcium, FE, UIBC, Inorganic Phosphorus and Magnesium in human serum.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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 Benson
Division: Sign-Off
Office of in Vitro Diagnostic Device Evaluation and Safety
510(k: K04255/
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