(138 days)
K912844/A
Not Found
No
The description details a chemical reaction and optical measurement process with calculations based on a standard curve, without mentioning any AI or ML components.
No
This device is an in vitro diagnostic (IVD) device used to measure GGT levels to aid in the diagnosis and treatment of liver diseases. It does not directly treat or prevent a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use... to aid in the diagnosis and treatment of liver diseases".
No
The device description clearly details a physical cartridge and an analyzer that performs mechanical and optical functions to measure GGT activity. This involves hardware components and processes, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The very first section explicitly states "For in vitro diagnostic use". It also describes the purpose of the device as measuring GGT from biological specimens (whole blood, plasma, or serum) to aid in the diagnosis and treatment of liver diseases. 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 details how the device interacts with the specimen outside of the body ("in vitro"). It describes a cartridge that receives a specimen, separates components, and uses reagents to measure a substance (GGT) within the specimen.
- Performance Studies: The performance studies describe how the device performs in analyzing specimens, including detection limits, reportable range, accuracy, precision, and method comparison with a predicate device. These are all characteristics evaluated for IVD devices.
- Predicate Device: The mention of a predicate device (Johnson and Johnson's Vitros GGT Slides) which is also an IVD, further supports the classification of this device as an IVD.
N/A
Intended Use / Indications for Use
The CARESIDE® GGT cartridge is intended for in vitro diagnostic use in conjunction with the CARESIDE® Analyzer to quantitatively measure GGT activity in anticoagulated whole blood, plasma or serum. For in vitro diagnostic use with the CARESIDE Analyzer to quantitatively measure GGT from anti-coagulated whole blood, plasma, or serum specimens to aid in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and primary and secondary liver tumors.
Product codes
75JPZ, JPZ
Device Description
CARESIDE® GGT cartridges are used with the CARESIDE Analyze® to measure GGT activity in anti-coagulated whole blood, plasma or serum specimens. The CARESIDE GGT 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 GGT activity. The patented film cartridge contains all reagents necessary to measure GGT activity. Each CARESIDE® GGT cartridge consists of a GGT-specific multi-layer reagent film mounted in a plastic base with a hinged lid. The user introduces the anti-coagulated whole blood, serum. or plasma 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 degrees Celsius, 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 8.5 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 spreading and substrate layer distributes the GGT containing specimen Uniformly. The GGT in the specimen reacts with the substrate L-y-glutamyl-p-nitroanilide to release p-nitroaniline resulting in a change in film color. The rate of change of color intensity, as measured by the amount of reflected light at 425 nanometers, directly relates to the specimen GGT activity. As the cartridges spin, photodiodes measure reflectance of light emitted by wavelengthspecific light emitting diodes (LEDs) over a fixed time period. The instrument uses the reflectance measurements and the lot-specific standard curve to calculate GGT 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)
The nonclinical and clinical data provided demonstrate that the CARESIDE® GGT 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.)
Detection limit: CARESIDE® GGT 20 U/L, Vitros GGT DT Slides 5 U/L
Reportable Range: CARESIDE® GGT 20 to 1000 U/L, Vitros GGT DT Slides 5 to 1400 U/L
Accuracy: CARESIDE® GGT Mean recovery 101%, Vitros GGT DT Slides Not available
Precision: CARESIDE® GGT Total CV, 344 U/L, 2.6%; Vitros GGT DT Slides Total CV, 166 U/L, 2.4%
Method Comparison: CARESIDE® GGT CARESIDE = 1.00 (BM/Hitachi 902 GGT) + 0.91 U/L, r= 1.00
Linearity: CARESIDE® GGT Linearity by dilution yielded slope and correlation coefficient within acceptable limits., Vitros GGT DT Slides Not available
Interference: CARESIDE® GGT No significant interference observed at tested concentration of interferent: Ascorbic Acid 10 mg/dL, Bilirubin 10 mg/dL, Triglycerides 3000 mg/dL; Vitros GGT DT Slides None stated
Specimen Types & Anticoagulants: CARESIDE® GGT No clinically significant difference between sodium heparinized whole blood, serum, and sodium heparin plasma.; Vitros GGT DT Slides No clinically significant difference between serum, heparin plasma, or EDTA plasma. Whole blood is unsuitable.
Predicate Device(s)
K912844/A
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1360 Gamma-glutamyl transpeptidase and isoenzymes test system.
(a)
Identification. A gamma-glutamyl transpeptidase and isoenzymes test system is a device intended to measure the activity of the enzyme gamma-glutamyl transpeptidase (GGTP) in plasma and serum. Gamma-glutamyl transpeptidase and isoenzymes measurements are used in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and primary and secondary liver tumors.(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 § 862.9.
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CARESIDE, Inc. Page 1
CARESIDE GGT Premarket Notification 1 2002 JUL
May 10, 2002
510(K) SUMMARY: CARESIDE® GGT SAFETY AND EFFECTIVENESS
I. Applicant Information
- A. Applicant Name
- B. Applicant/Manufacturer Address
- C. Telephone Number
- D. Contact Person
- E. FAX Number
- F. e-Mail Address
- Date 510(k) Summary prepared G.
II. Device Information
- A. Device Name (Trade)
- B. Device Name (Classification)
- C. Device Classification
CARESIDE, Inc. 6100 Bristol Parkway Culver City, CA 90230 310-338-6767 Renate A. MacLaren, Ph.D. 310-670-6986 rmaclaren@CARESIDE.com May 10, 2002
CARESIDE® GGT
GGT test system Clinical chemistry panel GGT test system Regulation Number: 21 CFR 862.1360 Regulatory Class 1 (non-exempt for point of care use) Classification Number: 75JPZ 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.
GGT in vitro diagnostic products, in both dry film and other formats, are currently marketed in the U.S., including GGT products which utilize GGT catalyzed generation of p-nitroaniline from the artificial substrate L-y-glutamyl-p-nitroanilide.
B. Specific equivalency claim
The CARESIDE® GGT test is substantially equivalent in principle, intended use, and clinical performance to the currently marketed Vitros slides for the quantitative measurement of GGT on the Vitros DTSC 60 II.
Name of Predicate Device: Johnson and Johnson's (formerly Eastman Kodak, Inc.) Vitros GGT Slides for Johnson and Johnson's Vitros DTSC 60 (formerly Eastman Kodak's DTSC 60 II).
Predicate Device 510K number: K912844/A Product Code: 75JPZ
1
IV. Device Description
CARESIDE® GGT cartridges are used with the CARESIDE Analyze® to measure GGT activity in anti-coagulated whole blood, plasma or serum specimens. The CARESIDE GGT 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 GGT activity. The patented film cartridge contains all reagents necessary to measure GGT activity.
A. Explanation of Device Function
Each CARESIDE® GGT cartridge consists of a GGT-specific multi-layer reagent film mounted in a plastic base with a hinged lid. The user introduces the anti-coagulated whole blood, serum. or plasma 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℃, 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 8.5 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 spreading and substrate layer distributes the GGT containing specimen The GGT in the specimen reacts with the substrate L-y-glutamyl-puniformly. nitroanilide to release p-nitroaniline resulting in a change in film color. The rate of change of color intensity, as measured by the amount of reflected light at 425 nanometers, directly relates to the specimen GGT activity.
Test Reaction Sequence:
L-Y-glutamyl-p-nitroanilide + glycylglycine
GGT ↓
L-glutamylglycylglycine + p-nitroaniline
As the cartridges spin, photodiodes measure reflectance of light emitted by wavelengthspecific light emitting diodes (LEDs) over a fixed time period. The instrument uses the reflectance measurements and the lot-specific standard curve to calculate GGT activity.
B. Test Summary
y-Glutamyltransferase measurements are used in the diagnosis and treatment of liver diseases including alcoholic cirrhosis and primary and secondary liver tumors. GGT in the serum originates primarily from the hepatobiliary system even though renal tissue contains the highest levels of GGT. GGT is elevated in all forms of liver disease. GGT elevations are observed earlier and are more pronounced than those of other liver enzymes in cases of obstructive jaundice and metastatic neoplasms. In intra- or posthepatic biliary obstruction, GGT levels may reach levels 5 to 30 times higher than in intra- or post-hepatic biliary obstruction
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V. Intended Use
A. Intended Use
The CARESIDE® GGT cartridge is intended for in vitro diagnostic use in conjunction with the CARESIDE® Analyzer to quantitatively measure GGT activity in anticoagulated whole blood, plasma or serum.
- Indications for Use B.
For in vitro diagnostic use with the CARESIDE Analyzer to quantitatively measure GGT from anti-coagulated whole blood, plasma, or serum specimens to aid in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and primary and secondary liver tumors.
Technological Characteristics VI.
- Similarities A.
| CARESIDE® GGT | Vitros GGT DT Slides | |
|---|---|---|
| Intended Use | For in vitro Diagnostic use | Same |
| Indications | Primarily to aid in the | |
| diagnosis and treatment of | ||
| patients with liver diseases | ||
| such as alcoholic cirrhosis and | ||
| primary and secondary liver | ||
| tumors. | Same | |
| Measurement | Quantitative | Same |
| Method | Dry film based quantitation of | Same |
| Principle | enzymatic activity by | |
| reflectance photometry using | ||
| L-g-glutamyl transferase and | ||
| glycylglycine substrate. | ||
| Specimen | Not required | Same |
| Dilution | ||
| Materials | L-y-glutamyl-p-nitroanilide | |
| and glycylglycine | L-y-glutamyl-p-nitroanilide | |
| and glycylglycine | ||
| Detector | Reflectance (425 nm) | Reflectance (400 nm) |
| Test Time | Approx. 4 min. warm-up (on- | |
| board) plus 5 minute test time. | 15 minutes slide warm-up (off- | |
| line) plus 5 minutes test time. | ||
| Sample Type | Anti-coagulated whole blood, | |
| serum or plasma [whole blood | ||
| applied sample, plasma test | ||
| sample] | Serum, plasma | |
| Specimen | 8.5 µl test volume | 10 µl |
| Volume | (90 ± 10 µl applied volume) | |
| Calibration | Calibration information bar- | |
| coded on each cartridge. | ||
| Calibration information may | ||
| change with each lot. | Run Vitros DTSC 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 |
3
B. Differences
| CARESIDE® GGT | Vitros GGT DT Slides | |
|---|---|---|
| Direct Blood | ||
| Specimen | Yes, whole blood | No, requires separation of |
| whole blood prior to | ||
| sample application | ||
| Reportable | ||
| range | 20 to 1000 U/L | 5 to 1400 U/L |
| Accurate | ||
| Pipetting | Not required | Required |
| Reagent Pre- | ||
| warming | Not required | Required |
C. Comparative Performance Characteristics
| CARESIDE® GGT | Vitros GGT DT Slides | |
|---|---|---|
| Detection limit | 20 U/L | 5 U/L |
| Reportable | ||
| Range | 20 to 1000 U/L | 5 to 1400 U/L |
| Accuracy | Mean recovery 101% | Not available |
| Precision | Total CV, 344 U/L, 2.6% | Total CV, 166 U/L, 2.4% |
| Method | ||
| Comparison | CARESIDE = 1.00 (BM/Hitachi 902 GGT) + 0.91 U/L, | |
| r= 1.00 | ||
| Linearity | Linearity by dilution | |
| yielded slope and | ||
| correlation coefficient | ||
| within acceptable limits. | Not available | |
| Interference | No significant interference | |
| observed at tested | ||
| concentration of | ||
| interferent: |
Ascorbic Acid 10 mg/dL
Bilirubin 10 mg/dL
Triglycerides 3000 mg/dL | None stated |
| Specimen Types
&
Anticoagulants | No clinically significant
difference between sodium
heparinized whole blood,
serum, and sodium heparin
plasma. | No clinically significant
difference between serum,
heparin plasma, or EDTA
plasma. Whole blood is
unsuitable. |
D. Conclusion
The nonclinical and clinical data provided demonstrate that the CARESIDE® GGT 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/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around it. Inside the circle is an abstract symbol that resembles three stylized human profiles or figures, possibly representing people or services provided by the department.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Renate A. MacLauren, Ph.D. Clinical Affairs Manager Careside. Inc. 6100 Bristol Parkway Culver City, CA 90230
Re: K020486 Trade/Device Name: Careside® GGT Regulation Number: 21 CFR 862.1360 Regulation Name: Gamma-glutamyl transpeptidase and isoenzymes test system Regulatory Class: Class I, reserved Product Code: JPZ Dated: May10, 2002 Received: May13, 2002
:
'JUL -
1 2002
Dear Dr. MacLauren:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Iisting 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 =
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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html",
Sincerely yours,
Steven Butman
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
6
K0204:86
INDICATIONS FOR USE
510(k). Number:
Device Name:
· CARESIDE® GGT
For in vitro diagnostic use with the CARESIDE Analyzer to quantitatively Indications for use: measure GGT from anti-coagulated whole blood, plasma, or serum specimens to aid in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and primary and secondary liver tumors.
Jean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K020486
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)