(433 days)
Not found
Not Found
No
The device description focuses on a chemical reaction and fluorescence measurement for quantitative analysis, with no mention of AI or ML technologies.
No.
The device is a reagent kit used for the quantitative determination of tyrosine in blood samples to screen for congenital tyrosinemia; it does not directly treat or diagnose a disease.
Yes
The device quantitatively determines amino acid tyrosine levels in whole blood, primarily to screen newborns for congenital tyrosinemia, a disease that can cause liver/kidney disorders. This direct measurement to identify a medical condition classifies it as a diagnostic device.
No
The device description clearly states it is a "set of reagents" and describes a chemical reaction and measurement of fluorescence, indicating it is a chemical assay kit, 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 method is for the "quantitative determination of the amino acid tyrosine in whole blood saturated filter paper disks." This is a measurement performed in vitro (outside the body) on a biological specimen (whole blood).
- Indications for Use: The indications for use state that the measurements are used "primarily to screen newborns for congenital tyrosinemia." This is a diagnostic purpose, using the in vitro measurement to aid in the identification of a disease.
- Device Description: The device is described as a "set of reagents" used with an analyzer to determine the amount of tyrosine in a biological sample. This aligns with the nature of IVD devices, which often involve reagents and analytical instruments to perform tests on biological specimens.
- Anatomical Site: The sample is "whole blood saturated filter paper disks," which is a biological specimen collected from the body.
The combination of performing a test on a biological specimen in vitro for a diagnostic purpose clearly classifies this device as an IVD.
N/A
Intended Use / Indications for Use
This method is for the quantitative determination of the amino acid tyrosine in whole blood saturated filter paper disks using the API™ 300 SPOTCHECK® Analyzer or the RFA 300 System. Measurements obtained by this device are used in the diagnosis and treatment of diseases such as congenital tyrosinemia, a disease that can cause liver/kidney disorders.
This method is for the quantitative determination of the amino acid tyrosine in whole blood saturated filter paper disks using the APF™ 300 SPOTCHECK® Analyzer or the RFA 300 System. Measurements obtained by this device are used primarily to screen newborns for congenital tyrosinemia, a disease that can cause liver/kidney disorders.
Product codes
CDR
Device Description
The proposed device, Tyrosine 50-Hour Reagent Kit, is a set of reagents to be used with the API™ 300 SPOTCHECK® Analyzer or the RFA 300 System for the quantitative determination of the amino acid tyrosine (Tyr) in whole blood saturated filter paper disks. The amount of Tvr is determined by measuring the fluorescent compound produced in the reaction of tyrosine with 1-nitroso-2-naphthol, catalyzed by nitrous acid at 80°C. The excitation wavelength of the product is 450 nm and emission is measured at 550 nm. The method is specific for para-substituted phenolic compounds. Excess 1-nitroso-2-naphthol is removed from the reaction mixture by reduction with sodium m-bisulfite.
The method is designed for mass screening, with enough reagents in each 50-Hour ' Reagent Kit for 1 week plus start-up (50 hours total) of run time. It is packaged to reduce storage space and to require a minimum of time to prepare. Each component is packaged with the correct weight to prepare the required volume of reagent. The standard is in a concentrated form, to permit easy dilution to prepare a standard curve.
The materials provided and their components are listed below.
| Reagent | Active Component(s) | Concentration | Volume |
|---|---|---|---|
| Extraction Buffer | Succinate Buffer | 6.0 mM | 1000 mL |
| Saline Diluent, 0.9% | Sodium Chloride | ||
| Triton X-100 | 154. mM | ||
| 0.05% | 600 mL | ||
| Complex Reagent | 1-Nitroso-2-Naphthol | ||
| DMSO | 1.5 mM | ||
| 3.5 M | 500 mL | ||
| Sodium Nitrite, 2.5% | Sodium Nitrite | 0.36 M | 10 mL |
| Nitrous Acid | Nitric Acid, 10% | ||
| Sodium Nitrite, 2.5% | 50 mL | ||
| 0.25 mL -Added before use | 50 mL | ||
| Sodium Metabisulfite | Sodium Metabisulfite | 0.26 M | 500 mL |
| Tyrosine Stock Standard, L-Tyrosine | |||
| 10 mg/dL | Hydrochloric Acid | 0.55 mM | |
| 6.0 mM | 50 mL |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
whole blood saturated filter paper disks
Indicated Patient Age Range
newborns
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical study: 1,096 specimens analyzed by the State of California's Genetic Disease Laboratory, of which 532 were normal neonatal blood samples and 521 were spiked samples. Results correlated well with the expected values for the spiked samples; all normal neonatal blood samples yielded tyrosine values within the normal range.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Technicon Tyrosine test
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1730 Free tyrosine test system.
(a)
Identification. A free tyrosine test system is a device intended to measure free tyrosine (an amono acid) in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of diseases such as congenital tyrosinemia (a disease that can cause liver/kidney disorders) and as an adjunct to the measurement of phenylalanine in detecting congenital phenylketonuria (a disease that can cause brain damage).(b)
Classification. Class I.
0
MAR 1 9 1998
Submitter's Name:
Address:
Telephone: FAX: Contact Person:
Date Summary Prepared:
NAME OF DEVICE
510(k) Summary
IDENTIFICATION
Astoria-Pacific, Inc.
503-657-3010
503-655-7367
February 3, 1998
14600 SE 82nd Drive
Raymond L. Pavitt, President
Clackamas, OR 97015-0830, USA
Lester B. Garrison, Diagnostics Manager
Tyrosine 50-Hour Reagent Kit Proprietary Name: Common Name: Free Tyrosine Test System 1-Nitroso-2-naphthol (Fluorometric), Free Tyrosine Classification Name:
LEGALLY MARKETED DEVICE EQUIVALENT TO PROPOSED DEVICE
The Tyrosine 50-Hour Reagent Kit is substantially equivalent to a legally marketed predicate device, Technicon Tyrosine test.
DESCRIPTION OF PROPOSED DEVICE
The proposed device, Tyrosine 50-Hour Reagent Kit, is a set of reagents to be used with the API™ 300 SPOTCHECK® Analyzer or the RFA 300 System for the quantitative determination of the amino acid tyrosine (Tyr) in whole blood saturated filter paper disks. The amount of Tvr is determined by measuring the fluorescent compound produced in the reaction of tyrosine with 1-nitroso-2-naphthol, catalyzed by nitrous acid at 80°C. The excitation wavelength of the product is 450 nm and emission is measured at 550 nm. The method is specific for para-substituted phenolic compounds. Excess 1-nitroso-2-naphthol is removed from the reaction mixture by reduction with sodium m-bisulfite.
The method is designed for mass screening, with enough reagents in each 50-Hour ' Reagent Kit for 1 week plus start-up (50 hours total) of run time. It is packaged to reduce storage
space and to require a minimum of time to prepare. Each component is packaged with the correct weight to prepare the required volume of reagent. The standard is in a concentrated form, to permit easy dilution to prepare a standard curve.
1
The materials provided and their components are listed below.
| Reagent | Active Component(s) | Concentration | Volume |
|---|---|---|---|
| Extraction Buffer | Succinate Buffer | 6.0 mM | 1000 mL |
| Saline Diluent, 0.9% | Sodium Chloride | ||
| Triton X-100 | 154. mM | ||
| 0.05% | 600 mL | ||
| Complex Reagent | 1-Nitroso-2-Naphthol | ||
| DMSO | 1.5 mM | ||
| 3.5 M | 500 mL | ||
| Sodium Nitrite, 2.5% | Sodium Nitrite | 0.36 M | 10 mL |
| Nitrous Acid | Nitric Acid, 10% | ||
| Sodium Nitrite, 2.5% | 50 mL | ||
| 0.25 mL -Added before use | 50 mL | ||
| Sodium Metabisulfite | Sodium Metabisulfite | 0.26 M | 500 mL |
| Tyrosine Stock Standard, L-Tyrosine | |||
| 10 mg/dL | Hydrochloric Acid | 0.55 mM | |
| 6.0 mM | 50 mL |
INTENDED USE
This method is for the quantitative determination of the amino acid tyrosine in whole blood saturated filter paper disks using the API™ 300 SPOTCHECK® Analyzer or the RFA 300 System. Measurements obtained by this device are used in the diagnosis and treatment of diseases such as congenital tyrosinemia, a disease that can cause liver/kidney disorders.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS OF DEVICE COMPARED TO PREDICATE DEVICE
Similarities with Predicate Device
The Astoria-Pacific SPOTCHECK® Tyrosine 50-Hour Reagent Kit is similar to the predicate device, Technicon Tyrosine test, having the same technological characteristics and intended use. Both are diagnostic reagent kits to be used for the quantitative, automated. fluorometric determination of the amino acid tyrosine in blood; both have the same chemical principles and reaction mechanism.
The reagents are identical, and there are no new reagents. The proposed device uses approximately the same temperatures, time and ratios of reagents as the predicate device.
Differences from Predicate Device
While the method and reagents are identical for the proposed and predicate devices, there are minor variations in the surfactants. The Technicon device uses Brij-35, while the proposed device uses Triton X-100, as it is available in a purified grade. In addition, the sample for the proposed device is whole blood spotted on filter paper and extracted with a
2
buffer; the sample for the predicate device is not specified. The proposed device is designed for a sampling rate of 90 per hour vs. 50 per hour for the predicate device.
There are also slight differences in the temperature of the assay and the wavelengths of the excitation and emission filters. The temperature of the assay, which affects the level of fluorescence produced, is 80°C for the 50-Hour Reagent Kit and 90°C for the Technicon Tyrosine test; temperatures from 55°C to 90°C are cited in the literature for this reaction. The Proposed device designates 450 nm and 550 nm for the excitation and emission wavelengths, respectively: the predicate device uses 440 nm and 540 nm, respectively. Because there is a broad bandpass of about 40 nm for the filters, and the emitted fluorescent light is broad spectrum, this difference is not consequential.
Other differences include concentration range (0-200 mg/L for Astoria-Pacific vs. 0-2 mg/L for Technicon), detection limit and upper limit of the assay, Also, the Technicon Tyrosine test required the user to prepare all reagents; in the 50-Hour Reagent Kit, the reagents are either pre-made or pre-weighed.
The minor differences between the Astoria-Pacific SPOTCHECK® Tyrosine 50-Hour Reagent Kit and the Technicon Tyrosine test raise no questions of safety or efficacy.
BRIEF DISCUSSION OF NONCLINICAL TESTS
Because there is such a strong similarity between the Astoria-Pacific SPOTCHECK® Tyrosine 50-Hour Reagent Kit and the Technicon Tyrosine test, no nonclinical testing has been performed to demonstrate substantial equivalence to the predicate device.
BRIEF DISCUSSION OF CLINICAL TESTS
Clinical testing has been performed on whole blood saturated filter paper disks. These test include 1,096 specimens analyzed by the State of California's Genetic Disease Laboratory, of which 532 were normal neonatal blood samples and 521 were spiked samples. Results correlated well with the expected values for the spiked samples; all normal neonatal blood samples yielded tyrosine values within the normal range. Other testing is described in the product labeling.
CONCLUSIONS DRAWN FROM THE NONCLINICAL AND CLINICAL TESTS
The clinical tests demonstrate that the proposed device, the Astoria-Pacific SPOTCHECK® Tyrosine 50-Hour Reagent Kit, is safe and performs as well as or better than the predicate device.
OTHER INFORMATION
No other information has been requested by the FDA at this time.
End of 510(k) SUMMARY.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its head and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the bird figure.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 19 1998
Raymond L. Pavitt . President Astoria-Pacific, Inc. 14600 SE 82nd Drive Clackamas, Oregon 97015-0830
Re: K970093 Tyrosine 50-Hour Reagent Kit Requlatory Class: II Product Code: CDR February 4, 1998 Dated: February 5, 1998 Received:
Dear Mr. Pavitt:
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 reqistration, 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. ਸੁ 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 requlation (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 requlation may result in requlatory 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.
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 Other qeneral 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
5
Page _ of _
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ o Harr Reagent Kit. Device Name: Indications For Use:
This method is for the quantitative determination of the amino acid tyrosine in whole blood saturated filter paper disks using the APF™ 300 SPOTCHECK® Analyzer or the RFA 300 System. Measurements obtained by this device are used primarily to screen newborns for congenital tyrosinemia, a disease that can cause liver/kidney disorders.
(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
(Division Sigri-Off)
Division of
510(k) Number. 12970092
Over-The-Counter Use
(Optional Format 1-2-96)
MAR-13-1998 છેર: 18 301 5945949
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