(46 days)
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No
The summary describes a calibrator for an in vitro diagnostic assay, which is a chemical reference standard, not a software-based device that would typically incorporate AI/ML. There are no mentions of AI, ML, image processing, or software algorithms.
No
This device is for in vitro diagnostic use, specifically as a calibrator for a microalbumin assay in human urine, and is not applied to a patient for therapeutic purposes.
No
This device is described as a calibrator for an assay, meaning it is used to establish reference points for measurements, not to perform a diagnosis itself.
No
The device description clearly states it is a "Multi-Calibrator Set" and is intended for "IN VITRO diagnostic use," indicating it is a physical calibrator used in a laboratory setting, not a software-only device.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" explicitly states "For IN VITRO diagnostic use".
- Device Description: The description mentions it's "intended for medical purposes for use in an albumin test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens." This aligns with the definition of an IVD, which is used to examine specimens from the human body to provide information for diagnostic purposes.
The fact that it's a calibrator for an assay that quantifies albumin in human urine further confirms its role within an in vitro diagnostic process.
N/A
Intended Use / Indications for Use
For IN VITRO diagnostic use as a calibrator for the DCL Microalbumin Assay for quantitation of albumin in human urine,
Product codes
JIX
Device Description
The DCL Microalbumin Multi-Calibrator Set, Cat. No. SE-252 is a device intended for medical identification purposes for use in an albumin test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens.
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
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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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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 depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Public Health Service
OCT 4 - 2004
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Nancy Olscamp Regulatory Affairs Coordinator, External, Diagnostic Division Diagnostic Chemicals Limited 16 McCarville Street Charlottetown, PE Canada CIE 2A6
Re: K042243 Trade/Device Name: Microalbumin Multi-Calibrator Set, Cat. No. SE-252 Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: August 16, 2004 Received: August 19, 2004
Dear Ms. Olscamp:
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) 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,
Jean M. Cooper, M.S., DVM.
Tean 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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Diagnostic Chemicals Limi
510(K) Notification
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Microalbumin Multi-Calibrator Set
Product Cat. No. SE-2
INDICATIONS FOR USE
11 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1
510(k) Number:
Device Name:
Microalbumin Multi-Calibrator Set, Cat. No. SE-252
For IN VITRO diagnostic use as a calibrator for the DCL Microalbumin Assay for quantitation of albumin in human urine,
Indications for Use:
PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
Subpart B -- Clinical Chemistry Test Systems
Sec. 862.1150 Calibrator
- The DCL Microalbumin Multi-Calibrator Set, Cat. No. SE-252 is a device intended for medic: ldentification. (a) purposes for use in an albumin test system to establish points of reference that are used in th determination of values in the measurement of substances in human specimens.
- Classification. Class II. (b)
Prescription Use: (Part 21 CFR 801 Subpart D)
And/or
Over-the-Counter Use (OTC): (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)
Alfred S. A'
Division Sign-Off
Office of In Vitro Dia Device Evaluation and Safety
510(k) K04/2243