(8 days)
K912844/A
Not Found
No
The summary describes a standard in vitro diagnostic test cartridge and analyzer for measuring alkaline phosphatase activity, with no mention of AI, ML, or related technologies.
No.
The device is an in vitro diagnostic (IVD) test used to measure alkaline phosphatase, which aids in the diagnosis and treatment of diseases. It does not directly provide therapy or treatment to a patient.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "For in vitro diagnostic use" and that it "aid[s] in the diagnosis and treatment of patients". The "Device Description" also refers to the cartridge as a "single use disposable in vitro diagnostic test cartridge".
No
The device description explicitly mentions a "CARESIDE Analyzer™" and "CARESIDE™ ALP cartridges," which are physical components used for in vitro diagnostic testing. This indicates the device is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use".
- Device Description: The "Device Description" also refers to the cartridge as a "single use disposable in vitro diagnostic test cartridge".
- Function: The device measures alkaline phosphatase from biological specimens (whole blood, serum, or plasma) to aid in the diagnosis and treatment of diseases. This is a core function of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CARESIDE™ ALP cartridge is intended for in vitro diagnostic use in conjunction with the CARESIDE Analyzer™ to quantitatively measure alkaline phosphatase activity in anticoagulated whole blood, serum or plasma.
This product is indicated for use in the diagnosis and treatment of patients with diseases of the liver, pancreas, bone, parathyroid, and intestines.
Product codes
75CJE, CJE
Device Description
CARESIDE™ ALP cartridges are used with the CARESIDE Analyzer™ to measure alkaline phosphatase activity in anticoagulated whole blood, serum or plasma specimens. The CARESIDE™ ALP cartridge, a single use disposable in vitro diagnostic test cartridge, delivers a measured volume of serum or plasma to a dry film to initiate the measurement of alkaline phosphatase activity. The film cartridge (patent pending) contains all reagents necessary to measure alkaline phosphatase activity.
Each CARESIDE™ ALP cartridge consists of an alkaline phosphatase-specific multilayer reagent film mounted in a plastic base with a hinged lid. The user introduces the specimen into the cartridge Sample 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°C, and spins the cartridge to move the sample from the Sample Well into the cartridge channels and chambers. 8.5 microliters of sample remains in the metering passage. Any excess sample flows into an overflow well.
The sample is automatically dispensed onto the multi-layer reagent film. The spreading and substrate layer distributes the sample uniformly. Under alkaline pH conditions, ALP catalyzes the conversion of pNPP to pNP. pNP diffuses through the detection layer and into the underlying buffer where pNP converts non-enzymatically to p-nitrophenoxide which has an intense yellow color. The rate of change of color intensity of the resulting yellow dye, as measured by the amount of reflected light at 425 nanometers, directly relates to the alkaline phosphatase activity of the specimen.
Test Reaction Sequence: p-Nitrophenyl Phosphate + H20 ALP ↓ p-Nitrophenol + Phosphoric Acid
As the cartridges spin, a photodiode measures reflectance of light emitted by a wavelength-specific light emitting diode (LED) over a fixed time period. The analyzer uses the reflectance measurements and the lot-specific standard curve to calculate alkaline phosphatase activity.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparative Performance Characteristics
- Detection limit: CARESIDE™ ALP: 30 U/L; Vitros ALKP DT Slides: 15 U/L
- Reportable range: CARESIDE™ ALP: 30 to 2500 U/L; Vitros ALKP DT Slides: 15 to 1500 U/L
- Accuracy: CARESIDE™ ALP: Mean recovery 94%; Vitros ALKP DT Slides: Not provided
- Precision: CARESIDE™ ALP: Total CV, 32 U/L, 12%; Vitros ALKP DT Slides: Total CV, 74 U/L, 5%
- Method comparison: CARESIDE™ = 0.93 (Trace Scientific ALP) +76 U/L, r = 0.99; CARESIDE™ = 1.29 (Vitros ALKP DT) – 10.2 U/L, r = 0.98. Vitros ALKP DT Slides: Not provided
- Linearity: CARESIDE™ ALP: Linearity studies yielded slope and correlation coefficient within acceptable limits.; Vitros ALKP DT Slides: Not provided
- Interference: CARESIDE™ ALP: No significant interference observed at tested concentration of interferent: Ascorbic Acid, 10 mg/dL; Hemoglobin, 100 mg/dL; Triglycerides 1500 mg/dL; Vitros ALKP DT Slides: Theophylline causes slight negative interference.
Conclusion
The nonclinical and clinical data provided demonstrate that the CARESIDE™ ALP product is as safe, effective, and performs as well as or better than the legally marketed predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K912844/A
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1050 Alkaline phosphatase or isoenzymes test system.
(a)
Identification. An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.(b)
Classification. Class II.
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JAN 1 3 1999
CARESIDE, Inc.
Page 10
CARESIDE™ ALP Premarket Notification December 30, 1998
510(K) SUMMARY: CARESIDE™ ALP SAFETY AND IV. EFFECTIVENESS
I. Applicant Information
- Applicant Name A.
- Applicant/Manufacturer Address B.
- Telephone Number C.
- D. Contact Person
- E. FAX Number
- F. e-Mail Address
- 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@CARESIDE.com December 30, 1998
CARESIDE™ ALP
Alkaline phosphatase test system Clinical chemistry panel Alkaline phosphatase test system Regulation Number: 21 CFR 862.1050 Regulatory Class 2 Classification Number: 75CJE 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.
Alkaline phosphatase in vitro diagnostic products, in both dry film and other formats, are already on the U.S. market, including alkaline phosphatase products which utilize pnitrophenyl phosphate substrate.
B. Specific equivalency claim
This CARESIDE™ ALP test is substantially equivalent in principle, intended use, and clinical performance to the currently marketed Vitros slides for the quantitative measurement of alkaline phosphatase using the Vitros DT 60 II with the DTSC II module.
| Name of Predicate Device: | Johnson and Johnson's (formerly Eastman Kodak,
Inc.) Vitros ALKP Slides for Johnson and Johnson's
Vitros DT 60 II System with the DTSC II module
(formerly Eastman Kodak's DT 60 II). |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Device 510K number: | K912844/A |
| Product Code: | 75CJE |
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IV. Device Description
CARESIDE™ ALP cartridges are used with the CARESIDE Analyzer™ to measure alkaline phosphatase activity in anticoagulated whole blood, serum or plasma specimens. The CARESIDE™ ALP cartridge, a single use disposable in vitro diagnostic test cartridge, delivers a measured volume of serum or plasma to a dry film to initiate the measurement of alkaline phosphatase activity. The film cartridge (patent pending) contains all reagents necessary to measure alkaline phosphatase activity.
A. Explanation of Device Function
Each CARESIDE™ ALP cartridge consists of an alkaline phosphatase-specific multilayer reagent film mounted in a plastic base with a hinged lid. The user introduces the specimen into the cartridge Sample 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°C, and spins the cartridge to move the sample from the Sample Well into the cartridge channels and chambers. 8.5 microliters of sample remains in the metering passage. Any excess sample flows into an overflow well.
The sample is automatically dispensed onto the multi-layer reagent film. The spreading and substrate layer distributes the sample uniformly. Under alkaline pH conditions, ALP catalyzes the conversion of pNPP to pNP. pNP diffuses through the detection layer and into the underlying buffer where pNP converts non-enzymatically to p-nitrophenoxide which has an intense yellow color. The rate of change of color intensity of the resulting yellow dye, as measured by the amount of reflected light at 425 nanometers, directly relates to the alkaline phosphatase activity of the specimen.
Test Reaction Sequence: p-Nitrophenyl Phosphate + H20 ALP ↓ p-Nitrophenol + Phosphoric Acid
As the cartridges spin, a photodiode measures reflectance of light emitted by a wavelength-specific light emitting diode (LED) over a fixed time period. The analyzer
B. Test Summary
alkaline phosphatase activity.
Alkaline phosphatase consists of a group of at least five isoenzymes which catalyze the hydrolysis of phosphate mono-esters optimally at an alkaline pH. These isoenzymes vary in their tissue distribution. ALP is found in the kidney, small intestine, osteoblasts, placenta, and liver. Significant elevations of ALP activity in the blood result from hepatobiliary disorders and bone disease associated with increased osteoblastic activity. Modest ALP elevation occurs in pregnancy, congestive heart failure, ulcerative colitis, intra-abdominal infections, Hodgkin's disease and other malignancies. Certain drugs can cause elevation in ALP activity in the blood in vivo.
uses the reflectance measurements and the lot-specific standard curve to calculate
2
V. Intended Use
Intended Use A.
The CARESIDE™ ALP cartridge is intended for in vitro diagnostic use in conjunction with the CARESIDE Analyzer™ to quantitatively measure alkaline phosphatase activity in anticoagulated whole blood, serum or plasma.
- B. Indications for Use
This product is indicated for use in the diagnosis and treatment of patients with diseases of the liver, pancreas, bone, parathyroid, and intestines.
Technological Characteristics VI.
- Similarities A.
| CARESIDE™ ALP | Vitros ALKP DT Slides | |
|---|---|---|
| Intended Use | Primarily to aid in the diagnosis and treatment of patients with diseases of the liver, pancreas, bone, parathyroid, and intestines. | Primarily to aid in the diagnosis of heptobiliary and bone diseases. |
| Indications | For in vitro diagnostic use. | For in vitro diagnostic use |
| Measurement | Quantitative | Same |
| Method Principle | Dry film based already on the U.S. market, including alkaline phosphatase products which utilize p-nitrophenyl phosphate substrate. | Same |
| Specimen dilution | Not required | Same |
| Materials | p-Nitrophenyl phosphate | Same |
| Detector | Reflectance (425 nm) | Reflectance (400 nm) |
| Test time | Approx. 4-minute warm-up (on-board) plus 6 minute test time. | 15 minutes slide warm-up (off-line) plus 5 minutes test time. |
| Reference Method | IFCC, 1983 | Bretaudiere, 1977, 37 °C |
| Sample Type | Whole blood, serum or plasma | Serum or plasma |
| Specimen volume | 8.5 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 | U/L | Same |
| Reaction Temp | 37 °C | Same |
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B. Differences
| CARESIDE™ ALP | Vitros ALKP DT Slides | |
|---|---|---|
| Specimen | ||
| Processing | Not required | Required |
| Accurate | ||
| pipetting | Not required | Required |
| Reagent pre- | ||
| warming | Not required | Required |
C. Comparative Performance Characteristics
| CARESIDE™ ALP | Vitros ALKP DT Slides | |
|---|---|---|
| Detection limit | 30 U/L | 15 U/L |
| Reportable range | 30 to 2500 U/L | 15 to 1500 U/L |
| Accuracy | Mean recovery 94% | Not provided |
| Precision | Total CV, 32 U/L, 12% | Total CV, 74 U/L, 5% |
| Method | ||
| comparison | CARESIDE™ = 0.93 (Trace Scientific ALP) +76 U/L, r = 0.99 | |
| CARESIDE™ = 1.29 (Vitros ALKP DT) – 10.2 U/L, r = 0.98 | ||
| Linearity | Linearity studies yielded | |
| slope and correlation | ||
| coefficient within acceptable | ||
| limits. | Not provided | |
| Interference | No significant interference | |
| observed at tested | ||
| concentration of interferent: | ||
| Ascorbic Acid, 10 mg/dL | ||
| Hemoglobin, 100 mg/dL | ||
| Triglycerides 1500 mg/dL | Theophylline causes slight | |
| negative interference. |
D. Conclusion
The nonclinical and clinical data provided demonstrate that the CARESIDE™ ALP product is as safe, effective, and performs as well as or better than the legally marketed predicate device.
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Image /page/4/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is evenly spaced around the upper half of the circle.
JAN 1 3 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Kenneth B. Asarch, Pharm. D., Ph.D. Vice President, Quality Systems/ Regulatory Affairs Careside Inc. 6100 Bristol Parkway Culver City, California 90230
Re: K990024 Trade Name: CARESIDE™ ALP Regulatory Class: II Product Code: CJE Dated: December 30, 1998 Received: January 5, 1999
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 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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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/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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INDICATIONS FOR USE VI.
CARESIDE™ ALP
510(k) Number:
Device Name:
Indications for use:
For in vitro diagnostic use with the CARESIDE Analyzer™ to measure alkaline phosphatase from anticoagulated whole blood, serum or plasma specimens to aid in the diagnosis and treatment of patients with diseases of the liver, pancreas, bone, parathyroid, and intestines.
Alan Cooper
ivision Sign-Off Division of Clinical Laboratory Devices 510(k) Number
(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)