(60 days)
Not Found
Not Found
No
The summary describes a quality control material for assays and contains no mention of AI or ML.
No
The device is intended for in vitro diagnostic use in quality control procedures, not for treating any condition or disease.
Yes
The "Intended Use / Indications for Use" states "For in vitro diagnostic use in quality control procedures...".
No
The provided 510(k) summary describes an in vitro diagnostic quality control material, which is a physical substance used to monitor assay performance, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" explicitly states:
"For in vitro diagnostic use in quality control procedures to monitor the accuracy and precision of manual and automated acetaminophe salicylate assays."
This clearly indicates that the device is intended to be used in vitro (outside of the body) for diagnostic purposes (monitoring the performance of diagnostic assays).
N/A
Intended Use / Indications for Use
For in vitro diagnostic use in quality control procedures to monitor the accuracy and precision of manual and automated acetaminophe salicylate assays.
Product codes
DIF
Device Description
Not Found
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3280 Clinical toxicology control material.
(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(b)
Classification. Class I (general 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
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 features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol. The logo is simple and monochromatic.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 1 7 2004
Ms. Nancy Olscamp External Regulatory Affairs Coordinator Diagnostic Chemicals Limited 16 McCarville Street Charlottetown, PE Canada C1E 2A6
K041666 Re: Trade/Device Name: DC Aceta/ Sal Control, Cat. Nos. SE-008/SE-010 Regulation Number: 21 CFR 862.3280 Regulation Name: Clinical toxicology control material Regulatory Class: Class I Product Code: DIF Dated: June 16, 2004 Received: June 23, 2004
Dear Ms. Olscamp:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rovewed your beeermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for as stated in the encreated of 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 r ou may, mererere, mains 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 it may be subject to satin additions (CFR), Parts 800 to 895. In addition, FDA ean or lound in 1100 ements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r toase be determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I odetar blanded 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 preched 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, rr yourstions 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 Fouring 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, US, 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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| (K) Notification | Diagnostics Chemicals Limited DC Aceta/Sal, Cat. Nos. SE-008/SE |
|---|---|
| ------------------ | ----------------------------------------------------------------- |
INDICATIONS FOR USE
| 510(k) Number: | K041666 |
|---|---|
| Device Name: | DC Aceta/Sal Control, Cat. Nos. SE-008/SE- 010 |
| Indications for Use: | For in vitro diagnostic use in quality control procedures to monitor the accuracy and precision of manual and automated acetaminophe salicylate assays. |
| Prescription Use: | ✓ And/or Over-the-Counter Use (OTC): |
| (Part 21 CFR 801 Subpart D) | (21 CFR 807 Subpa |
(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
Division Sign-Off
Office of in Vitro Diagnostic
Device Evaluation and Safety
510(k) K041666