(56 days)
K912844/A
Not Found
No
The summary describes a chemical assay for measuring phosphorus concentration using a dry film cartridge and analyzer. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on standard analytical chemistry metrics.
No
This device is for in vitro diagnostic use, meaning it aids in diagnosis by measuring substances in samples from the body, not for directly treating a disease.
Yes
The device is explicitly stated as being "For in vitro diagnostic use" and is intended "to aid in the diagnosis and treatment of various disorders."
No
The device description explicitly states it is a single-use disposable in vitro diagnostic test cartridge used with an analyzer, indicating it is a hardware component and not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states "For in vitro diagnostic use". It also describes the purpose of the device as quantitatively measuring inorganic phosphorus from biological specimens (whole blood, plasma, or serum) to aid in the diagnosis and treatment of various disorders. This aligns perfectly with the definition of an in vitro diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description refers to the cartridges as "a single use disposable in vitro diagnostic test cartridge".
- Performance Studies: The document includes performance characteristics like detection limit, reportable range, accuracy, precision, and method comparison, which are typical evaluations for IVD devices.
- Predicate Device: The mention of a predicate device (Vitros PHOS DT) which is also an IVD, further supports the classification of this device as an IVD.
Therefore, based on the provided information, this device is clearly intended and described as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The CARESIDE™ Phosphorus cartridge is intended for in vitro diagnostic use in conjunction with the CARESIDE™ Analyzer to quantitatively measure phosphorus concentration in anti-coagulated whole blood, plasma or serum. The CARESIDE™ Phosphorus test aids in the diagnosis and treatment of various disorders including parathyroid gland and kidney diseases, and vitamin D imbalance.
For in vitro diagnostic use with the CARESIDE™ Analyzer to quantitatively measure inorganic phosphorus from anti-coagulated whole blood, plasma or serum specimens to aid in the diagnosis and treatment of various disorders. including parathyroid gland and kidney diseases, and vitamin D imbalance. It is intended for professional laboratory use: not for point of care or physician office laboratory use.
Product codes (comma separated list FDA assigned to the subject device)
75CEO
Device Description
CARESIDE™ Phosphorus cartridges are used with the CARESIDE™ Analyzer to quantitatively measure phosphorus concentration in anti-coagulated whole blood, plasma or serum specimens. The CARESIDE™ Phosphorus cartridge, a single use disposable in vitro diagnostic test cartridge, aids in specimen separation and delivers a measured volume of plasma or serum to a dry film to initiate the measurement of phosphorus concentration. The film cartridge (patent pending) contains all reagents necessary to measure phosphorus concentration.
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
professional laboratory use: not for point of care or physician office laboratory use.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The nonclinical and clinical data provided demonstrate that the CARESIDETM Phosphorus product is as safe, effective, and performs as well as or better than the legally marketed Vitros DT 60.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Detection limit: 0.5 mg/dL
Reportable range: 0.5 to 15 mg/dL
Accuracy: Mean recovery 97%
Precision: Total CV, 3.5 mg/dL, 4.0%
Method comparison: CARESIDE™ = 0.99 (Vitros PHOS DT) + 0.49, r = 1.00
Linearity: Linearity by mixing and by dilution yielded slope and correlation coefficients within acceptable limits.
Interference: No significant interference observed at tested concentration of interferent: Ascorbic Acid, 10 mg/dL; Bilirubin, 20 mg/dL; Hemoglobin, 100 mg/dL; d-Mannitol 800 mg/dL; Triglycerides 1500 mg/dL
Specimen Types & Anticoagulants: No clinically significant difference between sodium heparinized whole blood, serum, sodium heparin plasma, and EDTA plasma.
Expected Values: 2.2 to 4.4 mg/dL Central 95%
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.
K912844/A
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.
Not Found
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).
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.
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JUN 25 1998
CARESIDE™ PHOSPHORUS 510(K) SUMMARY: SAFETY AND EFFECTIVENESS
I. Applicant Information
- Applicant Name A.
- B. Applicant/Manufacturer Address
- C. Telephone Number
- D. Contact Person
- E. FAX Number
- e-Mail Address F.
- Date 510(k) Summary prepared G.
II. Device Information
- A. Device Name (Trade)
- Device Name (Classification) B.
- C. Device Classification
CARESIDE, Inc.
6100 Bristol Parkway Culver City, CA 90230 310-338-6767 Kenneth B. Asarch, Pharm.D., Ph.D. 310-338-6789 asarchk @ worldnet.att.net June 11, 1998
CARESIDE™ Phosphorus
Phosphate test system Clinical chemistry panel Phosphate test system Regulation Number: 21 CFR 862.1580 Regulatory Class I Classification Number: 75CEO None applicable
- D. Special controls and performance standards
III. Substantial Equivalence Claim
- A. General equivalency claim
The ability to monitor analyte-specific biochemical reactions in dry film and other formats is widely recognized and has gained widespread acceptance for use in chemistry assays.
Phosphorus in vitro diagnostic products, in both dry film and other formats, are already on the U.S. market. These products utilize dry film and other formats. These products utilize either direct complexation of inorganic phosphate or coupled reactions to form a chromogen. For example,
-
complexation of inorganic phosphate with ammonium l. Dry film molybdate coupled to conversion to heteropolymolbydate blue dye by reaction with p-methylaminophenol sulfate.
Vitros PHOS DT 60 slides for Vitros DT 60 II example: (formerly Kodak DT 60 II), Johnson & Johnson Clinical Diagnostics, Inc. -
- Wet chemistry complexation of inorganic phosphate with ammonium molybdate. Ammonium molybdate complex is reduced and the resulting change in absorbance at 340/660 nanometers is proportional to the amount of inorganic phosphorous present in the sample.
- Phosphate XTS™ for Olympus AU5200, example: Olympus America, Inc.
1
Specific equivalency claim B.
This CARESIDE™ Phosphorus test is substantially equivalent in principle, intended use, and clinical performance to the currently marketed Vitros slides for the quantitative measurement of phosphorus on the Vitros DT 60 II.
| Name of Predicate Device: | Johnson and Johnson's (formerly Eastman Kodak,
Inc.) Vitros PHOS Slides for Johnson and Johnson's
Vitros DT 60 (formerly Eastman Kodak's DT 60 II). |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Device 510K number: | K912844/A |
| Product Code: | 75CEO |
IV. Device Description
CARESIDE™ Phosphorus cartridges are used with the CARESIDE™ Analyzer to quantitatively measure phosphorus concentration in anti-coagulated whole blood, plasma or serum specimens. The CARESIDE™ Phosphorus cartridge, a single use disposable in vitro diagnostic test cartridge, aids in specimen separation and delivers a measured volume of plasma or serum to a dry film to initiate the measurement of phosphorus concentration. The film cartridge (patent pending) contains all reagents necessary to measure phosphorus concentration.
Explanation of Device Function A.
Each CARESIDE™ Phosphorus cartridge consists of a phosphorus-specific multi-layer reagent film mounted in a plastic base with a hinged lid. The user introduces the anticoagulated whole blood, serum, or plasma specimen into the cartridge sample deposition well, closes the lid and inserts the cartridge into the CARESIDE™ Analyzer.
Once loaded, the CARESIDE™ analyzer scans the cartridge barcode, brings the cartridge and the contained specimen to 37℃, and spins the cartridge to move the sample from the sample deposition well into the cartridge channels and chambers. As the cartridge continues to spin, the blood cells are separated from the plasma/serum and the cells accumulate in the separation well. Approximately ten microliters of plasma (or serum, as applicable) remain in the metering passage. Any excess sample flows into an overflow well.
The plasma (or serum, as applicable) is automatically dispensed onto the multi-layer reagent film. The test specimen is distributed uniformly by the spreading layer. Large molecular components, such as proteins and dye components are filtered out as the specimen passes into the reaction layer. Purine nucleoside phosphorylase (PNP) catalyzes the reaction of the inorganic phosphorus (H2PO4, HPO4") reacts with xanthosine to form xanthine and ribose-1-phosphoric acid. Xanthine oxidase (XOD) then catalyzes the oxidation of xanthine in the presence of water and oxygen to produce uric acid and hydrogen peroxide. Peroxidase (POD) then catalyzes the conversion of leuco dye and hydrogen peroxide to produce an imidazole blue dye and water. The intensity of the color as measured by the amount of reflected light at 655 nanometers directly relates to the specimen inorganic phosphorus concentration.
Test Reaction Sequence:
Xanthosine + inorganic phosphate -> Xanthine + Ribose-1-phosphoric acid
Xanthine + H2O + Oxygen -> Uric Acid + Hydrogen Peroxide
Hydrogen Peroxide + Leuco-dye -> Imidazole Blue Dye + 2 H20
As the cartridge spins, a photodiode measures film reflectance of light emitted from a wavelength-specific light emitting diode (LED) at a fixed time. The analyzer uses the reflectance measurements and the lot-specific standard curve to calculate phosphorus concentration.
2
B. Test Summary
Phosphate is required for generation of bony tissue and functions in the metabolism of glucose and lipids, in the maintenance of acid-base balance, and in the storage and transfer on energy from one site in the body to another. Phosphate enters the cell with glucose and is lowered after carbohydrate ingestion. For these reasons, blood phosphate levels must be controlled within narrow limits.
Determination of whole blood, serum or plasma phosphorus levels is used in the diagnosis and treatment of various disorders including parathyroid gland and kidney diseases, and vitamin D imbalance. Phosphorus levels are always evaluated in relation to calcium levels because there is an inverse relationship between the two. When phosphate rises rapidly and calcium drops, there is a high risk of arrhythmias and muscle twitching. Excess serum levels of one causes the kidneys to excrete the other.
Hypophosphatemia may be seen in hyperparathyroidism, Fanconi's syndrome, vitamin D deficiency in children (rickets) and adults (osteomalacia), chronic use of antacids, chronic alcoholism, malabsorption syndromes, hyperinsulinism and occasionally during hyperalimentation therapy.
Causes of hyperphosphatemia include chronic renal failure, Addison's disease, excessive ingestion of vitamin D. cytotoxic treatment of certain leukemias and lymphomas, metastatic bone tumors, hypocalcemia, diabetic ketoacidosis, and healing bone fractures.
V. Intended Use
- A. Intended Use
The CARESIDE™ Phosphorus cartridge is intended for in vitro diagnostic use in conjunction with the CARESIDE™ Analyzer to quantitatively measure phosphorus concentration in anti-coagulated whole blood, plasma or serum. The CARESIDE™ Phosphorus test aids in the diagnosis and treatment of various disorders including parathyroid gland and kidney diseases, and vitamin D imbalance.
B. Indications for Use
For in vitro diagnostic use with the CARESIDE™ Analyzer to quantitatively measure inorganic phosphorus from anti-coagulated whole blood, plasma or serum specimens to aid in the diagnosis and treatment of various disorders. including parathyroid gland and kidney diseases, and vitamin D imbalance. It is intended for professional laboratory use: not for point of care or physician office laboratory use.
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VI. Technological Characteristics
- Similarities A.
| CARESIDETM Phosphorus | Vitros PHOS DT Slides | |
|---|---|---|
| Intended Use | Primarily to aid in the diagnosis | |
| and treatment of phosphate | ||
| regulation disorders such as | ||
| parathyroid gland disease, | ||
| kidney disease, or vitamin D | ||
| imbalance. | Same | |
| Indications | For in vitro diagnostic use. | |
| For laboratory professional use: | ||
| not for point of care or | ||
| physician office laboratory use. | For in vitro diagnostic use | |
| Measurement | Quantitative | Same |
| Method Principle | Dry film based enzymatic | |
| generation of hydrogen | ||
| peroxide from inorganic | ||
| phosphate. Reaction of | ||
| chromogen with hydrogen | ||
| peroxide to form blue. Dye | ||
| quantitated by reflectance | ||
| measurement after fixed time. | Dry film, complexation of | |
| inorganic phosphate with | ||
| ammonium molybdate coupled | ||
| to conversion to | ||
| heteropolymolbydate blue dye | ||
| by reaction with p- | ||
| methylaminophenol sulfate | ||
| Specimen dilution | Not required | Same |
| Materials | Xanthosine purine nucleoside | |
| phosphorylase, | ||
| Diarylimidazole leuco-dye | p-methylaminophenol sulfate, | |
| ammonium molybdate | ||
| Detector | Reflectance (655 nm) | Reflectance (660 nm) |
| Test time | Approximately 4 minute warm- | |
| up (on-board) plus 5 minute test | ||
| time. | 15 minutes slide warm-up (off- | |
| line) plus 5 minutes test time. | ||
| Reference Method | Phosphomolybdate Reduced | Phosphomolybdate Reduced |
| Sample Type | Serum, plasma, anti-coagulated | |
| (wb) [wb applied sample, | ||
| plasma test sample] | serum, plasma | |
| Specimen volume | 10 μl test volume | |
| (85 ± 15 μl applied volume) | 10 μl | |
| Calibration | Calibration information bar- | |
| coded on each cartridge. | ||
| Calibration information may | ||
| change with each lot. | Run Vitros DT II calibrators | |
| whenever a new slide lot is | ||
| used or when necessary. | ||
| Quality Control | 2 levels | Same |
| Reporting Units | mg/dL or mmol/L | Same |
| Reaction Temp. | 37 °C | Same |
4
…
B. Differences
| CARESIDE™ Phosphorus | Vitros PHOS DT Slides | |
|---|---|---|
| Direct blood | ||
| specimen | Yes, whole blood | No, requires separation of |
| whole blood prior to sample | ||
| application | ||
| Reportable range | 0.5 to 15 mg/dL | 0.5 to 13 mg/dL |
| Accurate | ||
| pipetting | Not required | Required |
| Reagent pre- | ||
| warming | Not required | Required |
C. Comparative Performance Characteristics
| CARESIDE™ Phosphorus | Vitros PHOS DT Slides | |
|---|---|---|
| Detection limit | 0.5 mg/dL | 0.5 mg/dL |
| Reportable range | 0.5 to 15 mg/dL | 0.5 to 13 mg/dL |
| Accuracy | Mean recovery 97% | Not provided |
| Precision | Total CV, 3.5 mg/dL, 4.0% | Total CV, 4.9 mg/dL, 3.7% |
| Method | ||
| comparison | CARESIDE™ = 0.99 (Vitros PHOS DT) + 0.49, r = 1.00 | |
| Linearity | Linearity by mixing and by | |
| dilution yielded slope and | ||
| correlation coefficients within | ||
| acceptable limits. | Not provided | |
| Interference | No significant interference | |
| observed at tested | ||
| concentration of interferent: | ||
| Ascorbic Acid, 10 mg/dL | ||
| Bilirubin, 20 mg/dL | ||
| Hemoglobin, 100 mg/dL | ||
| d-Mannitol 800 mg/dL | ||
| Triglycerides 1500 mg/dL | Not provided | |
| Specimen Types | ||
| & Anticoagulants | No clinically significant | |
| difference between sodium | ||
| heparinized whole blood, | ||
| serum, sodium heparin | ||
| plasma, and EDTA plasma. | No clinically significant | |
| difference between serum, | ||
| heparin plasma, or EDTA | ||
| plasma. Whole blood is | ||
| unsuitable. | ||
| Expected Values | 2.2 to 4.4 mg/dL | |
| Central 95% | 2.5 to 4.5 mg/dL | |
| Central 95% |
D. Conclusion
The nonclinical and clinical data provided demonstrate that the CARESIDETM Phosphorus product is as safe, effective, and performs as well as or better than the legally marketed Vitros DT 60.
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of three human figures, possibly symbolizing health and well-being. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 25 1998
Kenneth B. Asarch, Ph.D. . VP Quality Systems and Regulatory Affairs CareSide, Inc. 6100 Bristol Parkway Culver City, California 90230
K981610 Re: CareSide™ Phosphorus Regulatory Class: I Product Code: CEO Dated: April 27, 1998 Received: April 30, 1998
Dear Dr. Asarch:
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 aqainst 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. ਸਿ 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 In addition, 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 requlations.
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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 Sitman
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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CARESIDE, Inc. Page 5
INDICATIONS FOR USE
K981610 510(k) Number:
Device Name:
CARESIDE™ Phosphorus
For in vitro diagnostic use with the CARESIDE™ Analyzer to quantitatively Indications for use: measure inorganic phosphorus from anti-coagulated whole blood, plasma or serum specimens to aid in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance. It is intended for professional laboratory use: not for point of care or physician office laboratory use.
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K981610
(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)