(173 days)
None
Not Found
No
The summary describes a quantitative determination assay (EIA) and contains no mention of AI, ML, image processing, or any related concepts.
No
The device is intended for the quantitative determination of circulating immune complexes (CIC) in serum or plasma, which is a diagnostic function, not a therapeutic one.
Yes
The device is intended for the "quantitative determination" of substances (circulating immune complexes) in biological samples (serum or plasma), which is a characteristic function of a diagnostic device.
No
The device is described as an EIA (Enzyme Immunoassay), which is a laboratory test method involving reagents and physical components, not solely software.
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" explicitly states that the device is for the "quantitative determination of circulating immune complexes (CIC) in serum or plasma." This describes a test performed in vitro (outside the body) on biological samples (serum or plasma) to provide diagnostic information (the quantity of CIC).
The other sections being "Not Found" or "Not Applicable" do not negate the clear indication in the Intended Use that this is an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The CIC-C1q EIA is intended for the quantitative determination of circulating immune complexes (CIC) in serum or plasma.
Product codes
DAK
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.5240 Complement components immunological test system.
(a)
Identification. A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q , C1r , C1s , C2 , C3 , C4 , C5 , C6 , C7 , C8 , and C9 , in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image is a black and white 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 feathers. The bird is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
JAN 2 9 2002
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Richard E. Conley President American Laboratory Products Company P.O. Box 451 Windham, New Hampshire 03087
K012576 Re: Trade/Device Name: ALPCO Diagnostic's CIC-C1q EIA Regulation Number: 21 CFR § 866.5240 Regulation Name: Complement Components Immunological Test System Regulatory Class: II Product Code: DAK Dated: December 19, 2002 Received: December 20, 2002
Dear Mr. Conley:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 310(t) premained a substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to regard many and the Medical Device Americal portor commerce prior to May 26, 1976, are exactived in accordance with the provisions of the Federal Food, DRAA devices that have been reclassified in accessor will of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval ap and Cosment Act (Act) that to hot require approvise the general controls provisions of the Act. The You may, therefore, market the devices, boyse requirements for annual registration, listing of general controls provisions of also leveling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classifica (sec above) the exist on one regulations affecting your device can
may be subject to such additional controls. Existing major regulations FRA su may oe subject to such additional bentler in the 21, Parts 800 to 898. In addition, FDA may be found in the Code of I ouch an engerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Frease oc advised that I DT 8 1556 and of the complies with other requirements of the Act that I DA has made a decorminations administered by other Federal agencies. You must or any Federal Statutes and regulations and admited to: registration and listing (21 commy with an the Act 3 requirements, were 801); good manufacturing practice requirements as set CFR in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic (200 fordin in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your 510(k) prematics notification. The FDA finding of substantial equivalence of your device to a legally marketed notification. The I D7X miding of succidential for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFF Part 801 and if you desire specific advice tor your do rices), please contact the Office of Compliance at additionally 607.10 for m Prue cliefics on the promotion and advertising of your device, (301) 594-4506. Additionally, 10. Queens at (301) 594-4639. Also, please note the regulation please contact the Orios of Complanes of premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small information on your responsionnes ander and its toll-free number (800) 638-2041 or Manufacturers International and Collibancer Pittp://www.fda.gov/cdrl/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page_1_of_1_
| 510(k) Number (if known): | K012576 |
|---|---|
| Device Name: | ALPCO Diagnostic's CIC-Clq |
Indications For Use:
The CIC-C1q EIA is intended for the quantitative determination The CIC-Circulating immune complexes (CIC) in serum or plasma of of circulating immano com-
Sousun S. Altaie
Laboratory Devices
510(k) Number K612576
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Usc_Y (Pcr 21 CFR 801.109) OR
Over-The-Counter Use_
(Optional Format 1-2-96)