(32 days)
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No
The summary describes a chemical assay for measuring inorganic phosphorus and does not mention any AI or ML components.
No
The device is described as being for "IN VITRO diagnostic use" to determine inorganic phosphorus levels in serum, indicating it is used for diagnosis, not treatment, of a disease or condition.
Yes
This device is for the quantitative determination of inorganic phosphorus in serum, and the results are used to indicate conditions like hyperphosphatemia or hypophosphatemia, which are associated with various diseases. This aligns with the definition of a diagnostic device as it provides information used to identify or monitor a disease or condition.
No
The device description clearly states it is a method for determining inorganic phosphorus based on chemical reactions and measuring a complex, indicating a laboratory assay that involves physical reagents and equipment, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For IN VITRO diagnostic use."
- Nature of the Test: The device is designed for the "quantitative determination of inorganic phosphorus in serum." This involves analyzing a biological sample (serum) outside of the body to provide diagnostic information about a patient's health status (phosphorus levels and their implications).
These two points are the key indicators that this device falls under the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
For the quantitative determination of inorganic phosphorus in serum. For IN VITRO diagnostic use. Increased serum inorganic phosphorus levels (hyperphosphatemia) are usually the result of Vitamin D overdose, hypoparathyroidism, or renal failure. Decreased serum levels (hypophosphotemia) usually result from rickets, hyperparathyroidism, or Fanconi Syndrome (a defect in absorption of phosphorus and other metabolites from the glomerular filtrate). (1)
Product codes
CEO
Device Description
The majority of methods for determining inorganic phosphorus are based on the reduction of a phosphorus-molybdate complex with a reducing agent resulting in the subsequent formation of molybdenum blue. In 1972, Daly and Ertingshausen introduced a method for inorganic phosphorus which measured the unreduced phosphorus-molybdate complex. This procedure is a modification of the Daly and Ertingshausen technique (2).
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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features the department's name arranged in a circular fashion around a stylized emblem. The emblem consists of a symbol resembling an abstract caduceus or a stylized representation of human figures.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 30 003
Karen Callbeck, R.T.B.Sc. · Requlatory Affairs Coordinator Diagnostic Chemicals Limited West Royalty Industrial Park Charlottetown, PE Canada C1E, 1B0
Re : K974858 Phosphorus-SL Assay Requlatory Class: CEO Product Code: Dated: December 19, 1997 Received: December 29, 1997
Dear Ms. Callbeck:
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 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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸੈ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 In addition, FDA may publish further announcements action. 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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Paqe 2
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 requlation 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/dsmamain.html".
Sincerely yours,
Steven Litman
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
2
510(k) Number (if known): K974858
Device Name: Phosphorus-SL Assay
Indications for Use:
For the quantitative determination of inorganic phosphorus in serum. For IN VITRO diagnostic use. Increased serum inorganic phosphorus levels (hyperphosphatemia) are usually the result of Vitamin D overdose, hypoparathyroidism, or renal failure. Decreased serum levels (hypophosphotemia) usually result from rickets, hyperparathyroidism, or Fanconi Syndrome (a defect in absorption of phosphorus and other metabolites from the glomerular filtrate). (1)
The majority of methods for determining inorganic phosphorus are based on the reduction of a phosphorus-molybdate complex with a reducing agent resulting in the subsequent formation of molybdenum blue. In 1972, Daly and Ertingshausen introduced a method for inorganic phosphorus which measured the unreduced phosphorus-molybdate complex. This procedure is a modification of the Daly and Ertingshausen technique (2).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K074258
Prescription Use
(Per 21 CFR 801.109
OR
Over-The-Counter Use
(Optional Format 1-2-96)