(322 days)
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No
The document describes a reagent kit and analyzer system for a biochemical assay, with no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is an in vitro diagnostic reagent kit used for screening for decreased levels of GALT activity in infants, not for direct treatment or therapy.
Yes
The device is described as being used "in the diagnosis and treatment of the hereditary disease galactosemia" and "for in vitro diagnostic use as an aid in screening for decreased levels of GALT activity in infants."
No
The device description clearly states it is a "set of reagents" and describes chemical reactions and measurements using specific hardware analyzers (API™ 300 SPOTCHECK® Analyzer or the RFA-300 System). This indicates it is a chemical reagent kit, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states, "This method is intended for in vitro diagnostic use as an aid in screening for decreased levels of GALT activity in infants." This directly aligns with the definition of an IVD, which is used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
- Device Description: The device 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 enzyme galactose-1-phosphate uridyttransferase (UT) in whole blood saturated filter paper disks." This describes a product designed to be used in vitro (outside the body) to analyze a biological sample (whole blood).
- Purpose: The purpose is to measure GALT activity, which is used "in the diagnosis and treatment of the hereditary disease galactosemia." This clearly indicates a diagnostic purpose.
N/A
Intended Use / Indications for Use
This Astoria-Pacific SPOTCHECK® UridyItransferase 50-Hour Reagent Kit is for the qualifative determination of galactose-1-phosphate uridyttransferase, EC 2.7.12 (GALT) activity in whole blood saturated filter paper disks (S&S 903 filter paper or equivalent), using the API™ 300 SPOTCHECK® Analyzer or the RFA-300 System. Measurements of galactose-1-phosphate undyttransferase are used in the diagnosis and treatment of the hereditary disease galactosemia. This method is intended for in vitro diagnostic use as an aid in screening for decreased levels of GALT activity in infants. This method is not for monitoring purposes.
Product codes (comma separated list FDA assigned to the subject device)
KQP
Device Description
The proposed device, Unidyttransferase 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 enzyme galactose-1-phosphate uridyttransferase (UT) in whole blood saturated filter paper disks. The amount of unidyltransferase activity is determined by measuring the fluorescent compound produced in the reaction of UT with galactose and UDP Glucose, followed by NADP reduction at 37°C. The excitation wavelength of the reaction product is 450 nm, and it's emission is measured at 550 nm. The method is specific for uridy transferase.
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 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 dikition to prepare a standard curve. The materials provided and their components are listed below.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
whole blood
Indicated Patient Age Range
infants
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)
Clinical testing was performed on whole blood saturated fitter paper disks. These tests include 27 specimens analyzed, of which 20 were normal neonatal blood samples and 7 were deficient samples from juveniles and adults. Results correlated well, as there were no false positives and no false negatives among any of the samples tested.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Sigma Galactose-1-Phosphate Uridyttransferase (Gal-PUT) Deficiency Screen
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.
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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).
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§ 862.1315 Galactose-1-phosphate uridyl transferase test system.
(a)
Identification. A galactose-1-phosphate uridyl transferase test system is a device intended to measure the activity of the enzyme galactose-1-phosphate uridyl transferase in erythrocytes (red blood cells). Measurements of galactose-1-phosphate uridyl transferase are used in the diagnosis and treatment of the hereditary disease galactosemia (disorder of galactose metabolism) in infants.(b)
Classification. Class II.
0
K90277
510(k) SUMMARY
Astoria-Pacific
UridyItransferase 50-Hour Reagent Kit
510(K) SUMMARY
IDENTIFICATION
Submitter's Name:
Address:
Telephone: FAX: Contact Person: Date Summary Prepared:
Raymond L. Pavitt, President Astoria-Pacific, Inc. 14600 SE 82nd Drive Clackamas, OR 97015-0830, USA 503-657-3010 503-655-7367 Lester B. Garrison, Diagnostics Manager August 4. 1997
NAME OF DEVICE
Proprietary Name: Common Name: Classification Name: Uridyttransferase (GALT) 50-Hour Reagent Kit Uridyltransferase (GALT) Test System 862.1315 Galactose-1-Phosphate UridyItransferase Test System
LEGALLY MARKETED DEVICE EQUIVALENT TO PROPOSED DEVICE
The Unided and 50-Hour Reagent Kit is substantially equivalent to a legally marketed predicate device, Sigma Galactose-1-Phosphate Uridyttransferase (Gal-PUT) Deficiency Screen.
DESCRIPTION OF PROPOSED DEVICE
The proposed device, Unidyttransferase 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 enzyme galactose-1-phosphate uridyttransferase (UT) in whole blood saturated filter paper disks. The amount of unidyltransferase activity is determined by measuring the fluorescent compound produced in the reaction of UT with galactose and UDP Glucose, followed by NADP reduction at 37°C. The excitation wavelength of the reaction product is 450 nm, and it's emission is measured at 550 nm. The method is specific for uridy transferase.
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 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 dikition to prepare a standard curve. The materials provided and their components are listed below.
DEC | | 1997
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1
510(k) SUMMARY
Astoria-Pacific
Uridy|transferase 50-Hour Reagent Kit
REAGENTS
| DESCRIPTION | Component | Concentration | Quantity |
|---|---|---|---|
| GALT Extraction Buffer | Succinate Buffer | ||
| pH 5.2 | 0.8 mM | 1 Liter | |
| Recipient Diluent | Tris Buffer, pH 7.8 | ||
| Triton X-100 | 100 mM | ||
| 0.5 mL/L | 1 Liter | ||
| GALT Buffer Part A. | Tris Buffer, pH 7.8 | ||
| NADP | |||
| Dithiothreitol | 100 mM | ||
| 1.3 mM | |||
| 1.0 mM | 5 x 150 mL | ||
| GALT Buffer Part B. | Magnesium | ||
| EDTA | |||
| Triton X-100 | 0.6 mM | ||
| 0.1 mM | |||
| 0.5 mL/L | |||
| PGluM Substrate Reagent | Glu-1-Phosphate | 10. mM | 10 mL |
| GALT Substrate Reagent | Gal-1-Phosphate | ||
| UDPG | |||
| G6PDH Yeast | |||
| PGluM Rabbit Muscle | 4.3 mM | ||
| 0.5 mM | |||
| 1.6 KU/L | |||
| 0.8 KU/L | 5 x 60 mL | ||
| NADH Stock Standard | TEA Buffer, pH 9.0 | ||
| NADH | 50 mM | ||
| 50 [Mu]M | 2 x 50 mL |
INTENDED USE
This Astoria-Pacific SPOTCHECK® Undyttransferase 50-Hour Reagent Kit is for the qualifative determination of galactose-1-phosphate uridyttransferase, EC 2.7.12 (GALT) activity in whole blood saturated filter paper disks (S&S 903 filter paper or equivalent), using the API™ 300 SPOTCHECK® Analyzer or the RFA-300 System. Measurements of galactose-1-phosphate undyttransferase are used in the diagnosis and treatment of the hereditary disease galactosemia. This method is intended for in vitro diagnostic use as an aid in screening for decreased levels of GALT activity in infants. This method is not for monitoring purposes.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS OF DEVICE COMPARED TO PREDICATE DEVICE
Similarities with Predicate Device
The Astoria-Pacific SPOTCHECK® Uricyttransferase 50-Hour Reagent Kit is similar to a predicate device, Sigma Galactose-1-Phosphate Unidythransferase (Gal-PUT) Deficiency Screen, having the same technological characteristics and intended use. Both are diagnostic reagent kits to be used for the qualitative, fluorometric determination of the enzyme uridy/transferase in blood; both have the same chemical principles and reaction mechanism.
2
510(k) SUMMARY
Astoria-Pacific
UridyItransferase 50-Hour Reagent Kit
The reactants and reactions are the same. Both devices use the same incubation temperature and a similar incubation time.
Differences from Predicate Device
While the method and reagents are similar for the proposed and predicate devices, there are minor differences. The Sigma device uses G6PD and PGluM from the sample for the reactions. The proposed device adds these enzymes to the reagent. The Sigma device requires manual reading of fluorescence; the API™ 300 SPOTCHECK® Analyzer reads the fluorescence automatically.
There are also differences in the wavelengths of the excitation and emission fitters. The proposed device designates 450 nm and 550 nm for the excitation and emission wavelengths, respectively; the Sigma device uses a broad band UV lamp for excitation and visual fluorometry for reading the emitted fluorescence. Because there is a broad bandpass of about 40 nm for the fitters on the APM 300 SPOTCHECK® Analyzer and the emitted fluorescent light is broad spectrum, this difference is not consequential.
The API Uridy/transferase 50-Hour Reagent Kit contains a NADH standard for comparision of the fluorescence readings.
The Sigma Gal-PUT Deliciency Screen test requires the user to prepare all reagents; in the Astoria-Pacific SPOTCHECK® Uridytransferase 50-Hour Reagents are either pre-made or pre-weighed.
The minor differences between the Asloria-Pacific SPOTCHECK® Uridyttransferase 50-Hour Reagent Kit and the Sigma Gal-PUT Deficiency Screen raise no questions of safety or efficacy.
BRIEF DISCUSSION OF NONCLINICAL TESTS
Because there is such a strong similarity between the Astoria-Pacific SPOTCHECK® Uridyttransferase 50-Hour Reagent Kit and the Sigma Gal-PUT Deficiency Screen, no nonclinical testing has been performed to demonstrate substantial equivalence.
BRIEF DISCUSSION OF CLINICAL TESTS
Clinical testing was performed on whole blood saturated fitter paper disks. These tests include 27 specimens analyzed, of which 20 were normal neonatal blood samples and 7 were deficient samples from juveniles and adults. Results correlated well, as there were no false positives and no false negatives among any of the samples tested.
CONCLUSIONS DRAWN FROM THE NONCLINICAL AND CLINICAL TESTS
The clinical tests demonstrate that the proposed device. the Astoria-Pacific SPOTCHECK® Undyttransferase 50-Hour Reagent Kit, is sate, effective and performs as well as a predicate device, as evidenced by the correlation of results obtained from clinical studies.
OTHER INFORMATION
No other information has been requested by FDA at this time.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC I I 1997
Lester B. Garrison Submission Correspondent Astoria-Pacific, Inc. 14600 S.E. 82nd Drive P.O. Box 830 Clackamas, Oregon 97015
K970277 Re : Uridyltransferase Test System Regulatory Class: II Product Code: KQP Dated: November 5, 1997 Received: November 6, 1997
Dear Mr. Garrison:
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, qood 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 labelinq 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 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 Bitman
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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Page _ of _
| Labels | Values |
|---|---|
| 510(k) Number (if known): | K970277 |
| Device Name: | Undy TRANSFERASE 50-HOUR REAGENT Kit |
| Indications For Use: |
october 8, 1997
Astoria-Pacific, Inc.
statement of Indications for use:
This Astoria-Pacific SPOTCHECK® UridyItransferase 50-Hour Reagent Kit is for the qualitative determination of galactose-1phosphate uridyItransferase (EC 2.7.7.12) (GALT) activity in whole blood saturated filter paper disks, S&S 903 filter paper or equivalent, using the API ™ 300 SPOTCHECK® Analyzer or the RFA-300 System. Measurements of galactose-1-phosphate uridy!transferase are used in the diagnosis and treatment of the hereditary disease galactosemia. This method is intended for In vitro diagnostic use as an aid in screening for decreased levels of GALT enzyme activity in infants. This method is not for monitoring purposes.
(Please Do Not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K96277 |
| OR | |
| Prescription Use | Over-The-Counter Use |
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
| (Division Sign-Off) |
|---|
| Division of Clinical Laboratory Devices |
| 510(k) Number |
TOTAL P.08