(62 days)
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No
The summary describes a standard immunoassay method for detecting antibodies and does not mention any AI/ML components or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML devices.
No
The device is described as an "Enzyme linked immunosorbent assay method" used for the "semi-quantitative determination" of substances in human serum, with results aiding in the "diagnosis of auto-immune diseases." It is explicitly stated "For in vitro diagnostic use only," meaning it is for testing samples outside the body, not for treating a condition within the body.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The results of the anti-Sm/RNP assay can be used as an aid in the diagnosis of auto-immune diseases including Mixed Connective Tissue Disease (MCTD)." and "For in vitro diagnostic use only."
No
The device is described as an "Enzyme linked immunosorbent assay method," which is a laboratory technique involving physical reagents and equipment, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "Enzyme linked immunosorbent assay method for the semi-quantitative determination of ten and the country liness of . DAR in byen secure Enzyme intiked minialioscroom and "ANP in human serum." This describes a test performed on a biological sample (human serum) outside of the body.
- "Uses: The results of the anti-Sm/RNP assay can be used as an aid in the diagnosis of auto-immune I he results of the anti-Sits Reviews assure Disease (MCTD). diseases including Mixed Connective Tissue Disease (MCTD)." This indicates the test is used for diagnostic purposes.
- "For in vitro diagnostic use only." This is a clear and direct statement that the device is intended for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
Enzyme linked immunosorbent assay method for the semi-quantitative determination of ten and the country liness of . DAR in byen secure Enzyme intiked minialioscroom and "ANP in human serum. Uses: The results of the anti-Sm/RNP assay can be used as an aid in the diagnosis of auto-immune I he results of the anti-Sits Reviews assure Disease (MCTD). diseases including Mixed Connective Tissue Disease (MCTD). For in vitro diagnostic use only.
Product codes
LKO
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
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing-like shapes, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 8 1999
Ms. Danielle M. Knight Quality Manager Cogent Diagnostics Limited Pentlands Science Park Bush Loan Penicuik EH26 OPL United Kingdom
K990624 Re:
Trade Name: Autostat™ II Anti-Sm/RNP ELISA Regulatory Class: II Product Code: LKO Dated: February 16, 1999 Received: February 25, 1999
Dear Ms. Knight:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 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__________________________________________________________________________________________________________________________________________________________________________
| 510(k) Number (if known): | K 990624 |
|---|---|
| Device Name: | Autostat II Anti-Sm/RNP |
Indications for Use
Enzyme linked immunosorbent assay method for the semi-quantitative determination of
ten and the country liness of . DAR in byen secure Enzyme intiked minialioscroom and "ANP in human serum.
Uses:
The results of the anti-Sm/RNP assay can be used as an aid in the diagnosis of auto-immune I he results of the anti-Sits Reviews assure Disease (MCTD).
diseases including Mixed Connective Tissue Disease (MCTD).
For in vitro diagnostic use only.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Tuta E. Maker
(Division Sign-Off)
Division of Clinical Laboratory Devices k9900
510(k) Number
Prescription Use √
(Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)