(16 days)
No
The description focuses on a biochemical assay and an automated analyzer for measuring enzyme activity. There is no mention of AI or ML in the device description, intended use, or performance studies.
No.
This device is an in vitro diagnostic assay used to measure enzyme activity for the diagnosis and treatment management of a hereditary disease, not to provide direct therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Measurements of GALT are used in the diagnosis and treatment of the hereditary disease galactosemia (disorder of galactose metabolism) in infants," and "For in vitro diagnostic use only." This indicates its use for diagnostic purposes.
No
The device description clearly outlines a chemical assay that utilizes reagents and a physical instrument (Bio-Rad CODA Analyzer) to perform measurements on dried blood spot samples. This involves hardware components and chemical processes, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For in vitro diagnostic use only."
- Intended Use: The assay is designed for the "qualitative determination of galactose-1-phosphate uridyl transferase activity in dried blood spot samples." This is a test performed on a biological sample (blood) outside of the body to provide information for diagnosis and treatment.
- Clinical Purpose: The measurements are used "in the diagnosis and treatment of the hereditary disease galactosemia." This directly relates the test results to a clinical condition.
- Sample Type: The assay uses "dried blood spot samples," which are biological specimens.
- Device Description: The description details the biochemical reactions and detection method used to analyze the blood sample.
- Performance Studies: The inclusion of performance studies like concordance, sensitivity, and precision are typical for IVD devices to demonstrate their analytical performance.
- Predicate Devices: The mention of predicate devices (K998027 and K961432) which are also GALT assays, further supports its classification as an IVD.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This assay is for the qualitative determination of galactose-1-phosphate uridyl transferase activity in dried blood spot samples using the Bio-Rad CODA Analyzer. Measurements of GALT are used in the diagnosis and treatment of the hereditary disease galactosemia (disorder of galactose metabolism) in infants.
For in vitro diagnostic use only.
Product codes
KQP
Device Description
The CODA GALT assay utilizes dried blood spot samples (DBS) eluted in a medium containing B-nicotinamide adenine dinucleotide phosphate (NADP), galactose-1-phosphate, uridine-5diphosphoglucose (UDPG), and a tetrazolium salt. During the manual elution step, GALT present in the specimen converts galactose-1-phosphate to glucose-1-phosphate, with the eventual reduction of NADP to NADPH.
After elution, the samples are placed on the CODA instrument and an aliquot of the eluate is transferred to a microwell. The optical density (OD) is read, then Enzyme Reagent is added. During the incubation that follows, the Enzyme Reagent converts NADPH generated by GALT and endogenous red cell enzymes to NADP, and the tetrazolium salt to a colored formazan dye which is detected at 570 nm. The OD is read again and the difference between the two OD readings is determined. GALT activity, in units/g hemoglobin or units/liter blood, is calculated from the difference in signal between the two absorbance readings. A unit is defined as the quantity of GALT that catalyzes the formation of 1 micromole of UDP galactose per gram of hemoglobin or per Liter blood per hour at 37℃. An external calibrator is not necessary because enzyme activity is measured directly with substrates in excess.
The CODA instrument is an integrated immunoassay analyzer intended for the automation of microplate based assays for in vitro diagnostic use.
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
infants
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
The CODA Neonatal GALT Assay was compared to the Microplate Neonatal GALT Assay to establish substantial equivalence.
- Study type: Comparison to existing device (Microplate Neonatal GALT Assay)
- Sample size: Not specified
- AUC: Not specified
- MRMC: Not specified
- Standalone performance: Not specified
- Key results:
- Concordance: 100% (to Manual)
- Analytical Sensitivity: 0.31 U/g Hb
- Within-run Precision: 6.2% - 8.8%
- Total Precision: 5.8% - 12.5%
- Interference of bilirubin, triglycerides, and protein: No Interference
Key Metrics
- Concordance: 100% (to Manual)
- Analytical Sensitivity: 0.31 U/g Hb
- Within-run Precision: 6.2% - 8.8%
- Total Precision: 5.8% - 12.5%
- Interference of bilirubin, triglycerides, and protein: No Interference
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
K93536
Special 510(k): Device Modification Summary Bio-Rad CODA Neonatal GALT Assay
| Submitter: | Bio-Rad Laboratories, Inc.
4000 Alfred Nobel Drive,
Hercules, California 94547
Phone: (510) 741-6298
FAX: (510) 741-6471 |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Elizabeth Tang
Regulatory Affairs Specialist |
| Date of Summary Preparation: | October 18, 1999 |
| Device Name: | Bio-Rad CODA Neonatal GALT Assay |
| Classification Name: | Galactose-1-phosphate uridyl transferase test system |
| Predicate Device: | Microplate Neonatal GALT Assay
K998027
Bio-Rad Laboratories, Inc.
RADIAS GALT Assay
K961432
Bio-Rad Laboratories, Inc. |
| Statement of Intended Use: | This assay is for the qualitative determination of galactose-
1-phosphate uridyl transferase activity in dried blood spot
samples using the Bio-Rad CODA Analyzer.
Measurements of GALT are used in the diagnosis and
treatment of the hereditary disease galactosemia (disorder
of galactose metabolism) in infants.
For in vitro diagnostic use only. |
Description of Device
The CODA GALT assay utilizes dried blood spot samples (DBS) eluted in a medium containing B-nicotinamide adenine dinucleotide phosphate (NADP), galactose-1-phosphate, uridine-5diphosphoglucose (UDPG), and a tetrazolium salt. During the manual elution step, GALT present in the specimen converts galactose-1-phosphate to glucose-1-phosphate, with the eventual reduction of NADP to NADPH.
After elution, the samples are placed on the CODA instrument and an aliquot of the eluate is transferred to a microwell. The optical density (OD) is read, then Enzyme Reagent is added.
1
During the incubation that follows, the Enzyme Reagent converts NADPH generated by GALT and endogenous red cell enzymes to NADP, and the tetrazolium salt to a colored formazan dye which is detected at 570 nm. The OD is read again and the difference between the two OD readings is determined. GALT activity, in units/g hemoglobin or units/liter blood, is calculated from the difference in signal between the two absorbance readings. A unit is defined as the quantity of GALT that catalyzes the formation of 1 micromole of UDP galactose per gram of hemoglobin or per Liter blood per hour at 37℃. An external calibrator is not necessary because enzyme activity is measured directly with substrates in excess.
The CODA instrument is an integrated immunoassay analyzer intended for the automation of microplate based assays for in vitro diagnostic use.
Testing To Establish Substantial Equivalence
To establish substantial equivalence to an existing device, and thus establish the safety and effectiveness. the CODA Neonatal GALT Assay is compared to the Microplate Neonatal GALT Assay. A review of the intended use of each system shows them to be the same. The only differences between the protocols are the size of dried blood spots and volume of Substrate/Color reagent used. No significant changes were made in the assay reagents or procedure.
The CODA assay will use the same kit configuration as the 510(k) cleared Microplate GALT Assay (#K990827). Those using the kit for the CODA application will follow the instructions of a separate CODA application instruction note. This note will refer them to the main kit insert for all other information about the assay.
| Performance Tests | Acceptance Criteria | CODA Assay | Microplate Assay |
|---|---|---|---|
| Concordance | 100% | 100%(to Manual) | NA |
| Analytical Sensitivity | Trade Name: Bio-Rad CODA® Neonatal GALT Assay Regulatory Class: II Product Code: KQP Dated: October 18, 1999 Received: October 19, 1999 |
Dear Ms. Tang:
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 Sutman
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
4
Statement of Indications for Use
510(k) Number:
Device Name:
Indications for Use:
Bio-Rad CODA Neonatal GALT Assay
This assay is for the qualitative determination of galactose-1-phosphate uridyl transferase activity in dried blood spot samples using the Bio-Rad CODA Analyzer. Measurements of GALT are used in the diagnosis and treatment of the hereditary disease galactosemia (disorder of galactose metabolism) in infants.
For in vitro diagnostic use only.
Cooper
(Division Sign-Off)
Division of Clinical Laboratory vices
510(k) Number K993536
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescriptive Use
(Per 21 CFR 801.109) OR
Over-The-counter Use _