(62 days)
Not Found
Not Found
No
The summary describes a chemical reagent for laboratory testing, with no mention of AI or ML.
No
The device is described as an "Invitro" reagent for determining inorganic phosphate in serum or plasma, indicating it is for diagnostic or laboratory use, not therapeutic treatment of a disease or condition.
Yes
The device is described as "reagents...intended for Invitro...the determination of inorganic phosphate in serum, or plasma," which indicates its use in diagnosing or monitoring health conditions based on laboratory tests of biological samples.
No
The device description is not found, but the intended use clearly describes "inorganic phosphorus reagents," which are chemical substances used in laboratory testing, indicating a hardware component (the reagents themselves).
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"The inorganic phosphorus reagents: product No. 112-01 and 112-02 are intended for Invitro The morganic phosphords reagence from the determination of inorganic phosphate in serum, or plasma."
The term "Invitro" (or In vitro) is a key indicator that the device is intended for use outside of a living organism, which is the definition of an in vitro diagnostic. The purpose of determining inorganic phosphate in serum or plasma further confirms its use in analyzing biological samples in a laboratory setting.
N/A
Intended Use / Indications for Use
The inorganic phosphorus reagents: product No. 112-01 and 112-02 are intended for Invitro determination of inorganic phosphate in serum, or plasma.
Product codes
CEO
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
§ 862.1580 Phosphorus (inorganic) test system.
(a)
Identification. A phosphorus (inorganic) test system is a device intended to measure inorganic phosphorus in serum, plasma, and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.(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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle are three stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG - 2 1999
A.P. Total Care, Inc. c/o Mr. Luis P. Leon Catachem, Inc. P.O. Box 6216 Bridgeport, Connecticut 06606
Re: K991867 Trade Name: Inorganic Phosphorus (IP) Regulatory Class: I reserved Product Code: CEO Dated: May 27, 1999
Received: June 1, 1999
Dear Mr. Leon:
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 Toutman
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): 599 /84)
DEVICE NAME: INORGANIC PHOSPHORUS
(19)
INDICATIONS FOR USE:
The inorganic phosphorus reagents: product No. 112-01 and 112-02 are intended for Invitro The morganic phosphords reagence from the determination of inorganic phosphate in serum, or plasma.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
copy of Device Fuglustion (OFD)
Concurrence of CDRH, Office of Device Evaluation (OED)
Prescription Use (Per 21 CFR 801.109
OR
Over-The-Counter-Use (Optional Format 1-2-96)