(15 days)
Not Found
Not Found
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other indicators typically associated with AI/ML-powered medical devices. The intended use is a standard laboratory assay.
No
The device is used for detection and quantitation of antibodies, which is a diagnostic purpose, not a therapeutic one. Therapeutic devices are designed to treat or alleviate a condition.
Yes
The device is intended for "detection and quantitation of anti-dsDNA antibodies," which indicates its use in identifying a specific medical condition (systemic lupus erythematosus).
Unknown
The provided 510(k) summary lacks a device description, making it impossible to determine if the device is software-only or includes hardware components.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "For the detection and quantitation of anti-dsDNA antibodies in individuals with systemic lupus erythematosus (SLE)." This describes a test performed on biological samples (likely blood or serum) outside of the body to provide information about a person's health status (presence and level of antibodies related to SLE). This is the core definition of an in vitro diagnostic.
The other sections being "Not Found" don't negate the clear indication in the "Intended Use" section.
N/A
Intended Use / Indications for Use
For the detection and quantitation of anti-dsDNA antibodies in individuals with systemic lupus erythematosus (SLE).
Product codes
LKJ
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): 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.
Not Found
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.5100 Antinuclear antibody immunological test system.
(a)
Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).(b)
Classification. Class II (performance standards).
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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized lines forming the body and wings. Below the bird is a wavy line, possibly representing water or a ribbon.
Public Health Service
JAN - 8 2004
Food and Drug Administratio 2098 Gaither Road Rockville MD 20850
Ms. Nanci Dexter Director, Quality and Regulatory Corgenix, Inc. 12061 Tejon Street Westminister, CO 80234
K034013 Re: Trade/Device Name: REAADS® Anti-dsDNA Quantitative Test Kit Regulation Number: 21 CFR 866.5100 Regulation Name: Antinuclear antibody immunological test systems Regulatory Class: Class II Product Code: LKJ Dated: December 22, 2003 Received: December 23, 2003
Dear Ms, Dexter:
We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave reviewed your we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for answer in 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, de vices that mave been 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 r lease of advised that I Drisean 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 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 yours,
Steven Dutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety . Center for Devices and Radiological Health
Enclosure
2
Indications for Use Statement
510(k) Number: K034013
Device Name: REAADS® Anti-dsDNA Quantitative Test Kit Indications for Use:
For the detection and quantitation of anti-dsDNA antibodies in individuals with systemic lupus erythematosus (SLE).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Mana M. Chan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K03 4013