(28 days)
Not Found
No
The device description and performance studies describe a standard clinical chemistry assay based on a chemical reaction and absorbance measurement, with no mention of AI or ML.
No
The device is an in vitro diagnostic assay used for the quantitative determination of inorganic phosphorus, which aids in diagnosis and treatment, but it does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders." This indicates that the device provides information for diagnostic purposes.
No
The device description clearly states it is an "in vitro diagnostic assay" that involves a chemical reaction and measurement of absorbance at a specific wavelength (340 nm). This indicates a physical, chemical-based test, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the assay is "used for the quantitation of inorganic phosphorus in human serum, plasma, or urine." It also mentions that these measurements are "used in the diagnosis and treatment of various disorders." This aligns directly with the definition of an IVD, which is a device intended for use in the collection, preparation, and examination of specimens taken from the human body for the purpose of providing information for the diagnosis, treatment, or prevention of disease.
- Device Description: The description clearly states, "Phosphorus is an in vitro diagnostic assay for the quantitative determination of inorganic phosphorus in human serum, plasma, or urine." This is a direct self-identification as an IVD.
- Specimen Type: The assay uses human serum, plasma, or urine, which are biological specimens taken from the human body.
- Purpose: The purpose is to quantify inorganic phosphorus, and this information is used for diagnostic and treatment purposes.
The information provided strongly indicates that this device meets the criteria for an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Phosphorus assay is used for the quantitation of inorganic phosphorus in human serum, plasma, or 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.
Product codes
75CEO
Device Description
Phosphorus is an in vitro diagnostic assay for the quantitative determination of inorganic phosphorus in human serum, plasma, or urine. The Phosphorus assay is a clinical chemistry assay in which the inorganic phosphorus in the sample reacts with ammonium molybdate to form a heteropolyacid complex. The absorbance is measured at 340 nm and is directly proportional to the amount of inorganic phosphorus present in the sample.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
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)
Comparative performance studies were conducted using the AEROSET™ System. The Phosphorus assay method comparison yielded acceptable correlation with the Boehringer Mannheim Phosphorus assay on the Hitatch 717 Analyzer. The correlation coefficient = 0.9939, slope = 1.067, and the Y-intercept = 0.166 mg/dL. For the urine application, the correlation coefficient = 0.9872, slope = 1.040, and Y-intercept = 0.970 mg/dL. Precision studies were conducted using the Phosphorus assay. Within-run, between-run, and between-day studies were performed using two levels of control material. For the serum application, the total %CV for Level 1/Panel 101 control is 1.1% and Level 2/Panel 102 is 0.5%. For the urine application, the total %CV for Level 1/Panel 201 control is 1.6% and Level 2/Panel 202 is 1.5%. The Phosphorus assay is linear up to 25.3 mg/dL for the serum application, and 186.2 mg/dL for the urine application. The limit of quantitation (sensitivity) of the Phosphorus assay is 0.10 mg/dL. These data demonstrate that the performance of the Phosphorus assay is substantially equivalent to the performance of the Boehringer Mannheim Phosphorus assay on the Hitatch 717 Analyzer for both serum and urine applications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
correlation coefficient = 0.9939, slope = 1.067, Y-intercept = 0.166 mg/dL (serum); correlation coefficient = 0.9872, slope = 1.040, Y-intercept = 0.970 mg/dL (urine); total %CV for Level 1/Panel 101 control is 1.1% and Level 2/Panel 102 is 0.5% (serum); total %CV for Level 1/Panel 201 control is 1.6% and Level 2/Panel 202 is 1.5% (urine); linear up to 25.3 mg/dL (serum), and 186.2 mg/dL (urine); limit of quantitation (sensitivity) of the Phosphorus assay is 0.10 mg/dL.
Predicate Device(s)
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
1981759
JUN 1 6 1998
510(k) Summary
Submitter's Name/Address Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038
Contact Person Mark Littlefield Section Manager MS 1-8 Regulatory Affairs (972) 518-6062 Fax (972) 753-3367
| Date of Preparation of this Summary: | May 18, 1998 |
|---|---|
| Device Trade or Proprietary Name: | Phos |
| Device Common/Usual Name or Classification Name: | Phosphorus |
| Classification Number/Class: | 75CEO/Class I |
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is:
Test Description:
Phosphorus is an in vitro diagnostic assay for the quantitative determination of inorganic phosphorus in human serum, plasma, or urine. The Phosphorus assay is a clinical chemistry assay in which the inorganic phosphorus in the sample reacts with ammonium molybdate to form a heteropolyacid complex. The absorbance is measured at 340 nm and is directly proportional to the amount of inorganic phosphorus present in the sample.
Substantial Equivalence:
The Phosphorus assay is substantially equivalent to the following devices:
- Boehringer Mannheim® Phosphorus Assay (K872494) on the Hitachi® 717 . Analyzer
Phosphorus 510(k) May 18, 1998 Phos.lwp
Section II Page 1 0000011
1
These assays yield similar Performance Characteristics.
Similarities:
- Both assays are in vitro clinical chemistry methods. .
- Both assays can be used for the quantitative determination of inorganic . phosphorus.
- Both assays yield similar clinical results. .
Differences:
- There is a minor difference in the assay range. .
Intended Use:
The Phosphorus assay is used for the quantitation of inorganic phosphorus in human serum, plasma, or urine.
Performance Characteristics:
Comparative performance studies were conducted using the AEROSET™ System. The Phosphorus assay method comparison vielded acceptable correlation with the Boehringer Mannheim Phosphorus assay on the Hitatchi 717 Analyzer. The correlation coefficient = 0.9939, slope = 1.067, and the Y-intercept = 0.166 mg/dL. For the urine application, the correlation coefficient = 0.9872, slope = 1.040, and Y-intercept = 0.970 mg/dL. Precision studies were conducted using the Phosphorus assay. Within-run, between-run, and between-day studies were performed using two levels of control material. For the serum application, the total %CV for Level 1/Panel 101 control is 1.1% and Level 2/Panel 102 is 0.5%. For the urine application, the total %CV for Level 1/Panel 201 control is 1.6% and Level 2/Panel 202 is 1.5%. The Phosphorus assay is linear up to 25.3 mg/dL for the serum application, and 186.2 mg/dL for the urine application. The limit of quantitation (sensitivity) of the Phosphorus assay is 0.10 mg/dL. These data demonstrate that the performance of the Phosphorus assay is substantially equivalent
Section II Page 2 0000012
2
to the performance of the Boehringer Mannheim Phosphorus assay on the Hitatchi 717 Analyzer for both serum and urine applications.
Conclusion:
and model and the comments of
The Phosphorus assay is substantially equivalent to the Boehringer Mannheim Phosphorus assay on the Hitatchi 717 Analyzer for the serum and urine applications as demonstrated by results obtained in the studies.
Phosphorus 510(k) May 18, 1998 Phos.lwp
Section II Page 3
Property of the Property of
Image /page/2/Picture/5 description: The image shows a sequence of numbers, specifically "0000013". The numbers are printed in a bold, sans-serif font. The numbers are evenly spaced and aligned horizontally. The image appears to be a close-up of the numbers.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
| |
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
The I 6 1898
Mark Littlefield Section Manager, Regulatory Affairs Abbott Laboratories 1920 Hurd Drive Irvinq, Texas 75038
Re : K981759 Phosphorus Requlatory Class: I Product Code: CEO Dated: May 18, 1998 Received: May 19, 1998
Dear Mr. Littlefield:
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 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 Requlations, Title 21, Parts 800 to 895. ದ 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 requlation may result in requlatory In additi m, FDA may publish further announcements action. concerning your device in the Federal Reqister. 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.
4
Page 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 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/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
5
510(k) Number (if known): _ Jag Sil 2 1 S 10(k) 1
Device Name: _________________________________________________________________________________________________________________________________________________________________ Phosphorus --------
Indications For Use:
| 男
The Phosphorus assay is used for the quantitation of inorganic phosphorus in human serum, plasma, or 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.
(Division Sign-Off)
Division of Clinical Laboratory
510(k) Number. K981759
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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)
Phosphorus 510(k) May 18, 1998 Phos.lwp
000000000
6
510(k) Number (if known): _ Jog Stores 17 Sun
Device Name: _________________________________________________________________________________________________________________________________________________________________ Phosphorus
Indications For Use:
,
The Phosphorus assay is used for the quantitation of inorganic phosphorus in human serum, plasma, or 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.
(Division Sign-Off)
Division of Clinical Laboratory
510(k) Number K981759
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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)
Phosphorus 510(k) May 18, 1998 Phos.lwp
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