(435 days)
Not Found
No
The device description and performance studies focus on a chemical assay and colorimetric measurement, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
The device is for in vitro diagnostic use to aid in neonatal screening for increased concentrations of Total Galactose, primarily for diagnosis, not for treatment or therapy.
Yes
The device is explicitly stated to be for "in vitro diagnostic use as an aid in neonatal screening for increased concentrations of Total Galactose," where "Measurements of Total Galactose are used primarily in the diagnosis and treatment of the hereditary disease galactosemia." Its purpose is to detect a specific condition to support diagnosis.
No
The device is a reagent kit, which is a physical product containing chemical components used in a laboratory test. While it is used with a microplate reader (hardware) and potentially a "SPOTCHECK Pro" (which could be software or hardware), the core device being described and cleared is the reagent kit itself, which is not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the kit is "intended for in vitro diagnostic use as an aid in neonatal screening for increased concentrations of Total Galactose".
- Device Description: The description details a laboratory test system that analyzes biological samples (whole blood) outside of the body to provide diagnostic information.
- Performance Studies: The document includes details about performance studies (Linearity, Analytical Sensitivity, Method Comparison, Precision Performance, Analytical Specificity) which are typical for IVD devices to demonstrate their analytical and clinical performance.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K991498) indicates that this device is being compared to a previously cleared IVD device, a common process for regulatory submission of new IVDs.
N/A
Intended Use / Indications for Use
The SPOTCHECK® Neonatal Total Galactose Microplate Reagent Kit is for the quantitative determination of the concentration of Total Galactose (Gal) + galactose-1-phosphate (Gal-1-P)) in whole blood saturated filter paper disks, using a microplate absorbance reader or SPOTCHECK Pro. Measurements of Total Galactose are used primarily in the diagnosis and treatment of the hereditary disease galactosemia. This method is intended for in vitro diagnostic use as an aid in neonatal screening for increased concentrations of Total Galactose, and not for monitoring purposes.
Product codes
JIA
Device Description
SPOTCHECK Neonatal Total Galactose Microplate Reagent Kit Astoria-Pacific 60 Plate Kit Part No. 81-2000-60K Astoria-Pacific 5 Plate Kit Part No. 81-2000-05K Galactose test system
KIT CONTENTS:
.
Extraction Solution Enzyme Reagent Coenzyme Reagent Color Reagent Stock Standard
Total Galactose is measured colorimetrically following the completion of two enzyme assisted reactions and the color formation reaction; details and descriptions are provided below:
The first reaction entails conversion of Galactose-1-Phosphate (Gal-1-P) to Galactose (Gal), catalyzed by alkaline phosphatase.
Alkaline Phosphatase
Gal-1-P Gal t
In the second reaction, Gal is converted to galactonolactone through the galactose dehydrogenase NAD*/NADH-coupled reaction.
Galactose Dehydrogenase Gal + NAD+ -- - - - - galactonolactone + NADH
The NADH produced is proportional to the Gal concentration.
The final reaction, catalyzed by 1-methoxy PMS, employs a tetrazolium salt (MTT) and produces a formazan dye that is measured colorimetrically.
1-methoxy PMS NADH + MTT -- + Colored Formazan + NAD*
The color developed is proportional to the Total Galactose concentration in the sample. A standard curve prepared from a stock Galactose solution is used to quantitate the results.
Patient samples of whole blood collected on standardized filter paper are placed into the wells of a 96 well filtration microplate. Extraction solution (3% TCA) is added to each well and the samples are eluted at 37 ℃ for 60 minutes on a plate shaker/incubator. Following incubation the filter plate is placed on a vacuum manifold and its contents filtered into a clean flat-bottom microplate. Enzyme Reagent and Coenzyme Reagent are added to all wells and the plate is incubated at 37 ℃ for 30 minutes on a plate shaker/incubator. Color Reagent is then added to all wells and the plate is incubated for 10 minutes at 37 ℃ on a plate incubator/shaker. The absorbance is measured on a microplate reader at a wavelength of 600 nm for the measurement channel and 750 nm for the reference channel. Results are expressed as mg of total galactose per dL of whole blood.
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
Neonatal
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
An exemplary normal range was established by analyzing 2037 (2036 for SPOTCHECK Pro) routine samples at a state screening laboratory using the SPOTCHECK Kit both manually and automated. The same specimens were analyzed using a legally-marketed predicate device. In addition, 51 manufactured samples elevated in Total Galactose were tested with both the proposed and predicate devices for the purpose of sample classification comparison.
To supplement the initial clinical comparison study 11 retrospective confirmed galactosemic newborn specimens were obtained from the Michigan Neonatal Biobank. The specimens were blindly added amidst presumptive negative patient specimens and data was collected in two runs on each device over the course of two days in the Quality Control laboratory at Astoria-Pacific. Inc. The supplemental study brought the total number of neonatal specimens analyzed from 2037 to 2209 (2036 to 2208 for SPOTCHECK Pro).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
LINEARITY
The assay is linear in the range of 1.4 to 50 mg/dL, as confirmed by adherence to CLSI EP6-A: Evaluation of the Linearity of Ouantitative Measurement Procedures: A Statistical Approach: Approved Guideline. Responses of the standards give a correlation coefficient R2 > 0.995 using a 1st order curve from 0 to 50 mg/dL. Total galactose results 50 mg/dL are to be reported as such.
ANALYTICAL SENSITIVITY
The analytical sensitivity of the assay was determined by adherence to NCCLS EP 17-A Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline. The limit of detection (LoD) for Total Galactose utilizing manual processing is 1.4 mg/dL and utilizing SPOTCHECK PRO processing is 1.3 mg/dL. as calculated using the guidelines in NCCLS EP17-A protocol and with proportions of false positives (a) less than 0.1% and false negatives (B) less than 0.1%, based on 180 determinations. For ease of use when utilizing both processing options, the LoQ for SPOTCHECK Pro processing will be set at 1.4 mg/dL. The limit of blank (LoB) utilizing manual processing is 1.1 mg/dL and utilizing SPOTCHECK PRO processing is 0.9 mg/dL. To establish the LoQ. since an estimate of bias is not assured, the following goal for Total Error (TE) was used: "imprecision at any concentration greater than or equal to the LoO shall not exceed 20%". To evaluate imprecision within the data collected for this study (Sensitivity), %RSD was used as the metric. For both manual and SPOTCHECK PRO processing, %RSD is less than 20 for all levels that are at or above the LoO.
METHOD COMPARISON
Expected Values, Clinical Cutoff and Sample Classification Comparison
An exemplary normal range was established by analyzing 2037 (2036 for SPOTCHECK Pro) routine samples at a state screening laboratory using the SPOTCHECK Kit both manually and automated. The same specimens were analyzed using a legally-marketed predicate device. In addition, 51 manufactured samples elevated in Total Galactose were tested with both the proposed and predicate devices for the purpose of sample classification comparison.
To supplement the initial clinical comparison study 11 retrospective confirmed galactosemic newborn specimens were obtained from the Michigan Neonatal Biobank. The specimens were blindly added amidst presumptive negative patient specimens and data was collected in two runs on each device over the course of two days in the Quality Control laboratory at Astoria-Pacific. Inc. The supplemental study brought the total number of neonatal specimens analyzed from 2037 to 2209 (2036 to 2208 for SPOTCHECK Pro).
Data Summary:
| Total Galactose (mg/dL) | Predicate Device | Proposed Device -
Manual | Proposed Device -
SPOTCHECK Pro |
|-------------------------|------------------|-----------------------------|------------------------------------|
| # of Observations | 2268 | 2268 | 2267 |
| Mean Value Observed' | 3.3 | 3.4 | 3.6 |
| Standard Deviation' | 4.7 | 5.2 | 5.3 |
| Range of the Data' | 1.5 - 48.0 | 1.4 - 49.6 | 1.4 - 43.1 |
| 99th Percentileii | 7.2 | 6.7 | 7.0 |
| 99.5th Percentileii | 8.8 | 8.5 | 8.9 |
'Results for these statistics only apply to those samples with results ≥LoQ (≥1.4 for Proposed and ≥1.5 for Predicate) and
§ 862.1310 Galactose test system.
(a)
Identification. A galactose test system is a device intended to measure galactose in blood and urine. Galactose measurements are used in the diagnosis and treatment of the hereditary disease galactosemia (a disorder of galactose metabolism) in infants.(b)
Classification. Class I.
0
ASTORIA · PACIFIC
Neonatal Tota! Galactose Microplate Reagent Kit
510(k) Summary K121101
1. Name, Address of Contact Person
Applicant's name and address
Astoria-Pacific, Inc. FDA Establishment No. 3050015 15130 SE 82nd Drive P.O. Box 830 Clackamas, OR 97015-0830
Tel 1-503-657-3010 Fax 1-503-655-7367
Charles A. Peterson President
Jason Reynolds Director of R & D, Official Correspondent
2. Name of the Device
Product Classification
| Regulation Number | 21 CFR 862.1310 |
|---|---|
| 510(k) Number | |
| Classification Panel | Clinical Chemistry |
| Product Code | JIA |
| Device Classification | Class I |
| Product Nomenclature | |
| Common Name | Enzymatic Methods, Galactose |
| Classification Name | Galactose test system |
| Proprietary Name | Astoria-Pacific SPOTCHECK® Neonatal Total Galactose |
Microplate Reagent Kit
JUN 2 0 2013
":1
1
Identification of the legally-marketed device for which substantial 3. equivalence is claimed.
Product Classification
| Regulation Number | 21 CFR 862.1310 |
|---|---|
| 510(k) Number | K991498 |
| Classification Panel | Clinical Chemistry |
| Product Code | JIA |
| Device Classification | Class I |
Product Nomenclature
Common Name Enzymatic Methods, Galactose Classification Name Galactose test system Proprietary Name Accuwell Total Galactose Model Number(s) Accuwell Part No. 6020-20 EGAL, 2000 Test Kit
4. Description of the Device
SPOTCHECK Neonatal Total Galactose Microplate Reagent Kit
Astoria-Pacific 60 Plate Kit Part No. 81-2000-60K Astoria-Pacific 5 Plate Kit Part No. 81-2000-05K Galactose test system
KIT CONTENTS:
.
Extraction Solution Enzyme Reagent Coenzyme Reagent Color Reagent Stock Standard
Total Galactose is measured colorimetrically following the completion of two enzyme assisted reactions and the color formation reaction; details and descriptions are provided below:
The first reaction entails conversion of Galactose-1-Phosphate (Gal-1-P) to Galactose (Gal), catalyzed by alkaline phosphatase.
Alkaline Phosphatase
Gal-1-P Gal t
In the second reaction, Gal is converted to galactonolactone through the galactose dehydrogenase NAD*/NADH-coupled reaction.
Page 2 of 8
2
Galactose Dehydrogenase Gal + NAD+ -- - - - - galactonolactone + NADH
The NADH produced is proportional to the Gal concentration.
The final reaction, catalyzed by 1-methoxy PMS, employs a tetrazolium salt (MTT) and produces a formazan dye that is measured colorimetrically.
1-methoxy PMS NADH + MTT -- + Colored Formazan + NAD*
The color developed is proportional to the Total Galactose concentration in the sample. A standard curve prepared from a stock Galactose solution is used to quantitate the results.
Patient samples of whole blood collected on standardized filter paper are placed into the wells of a 96 well filtration microplate. Extraction solution (3% TCA) is added to each well and the samples are eluted at 37 ℃ for 60 minutes on a plate shaker/incubator. Following incubation the filter plate is placed on a vacuum manifold and its contents filtered into a clean flat-bottom microplate. Enzyme Reagent and Coenzyme Reagent are added to all wells and the plate is incubated at 37 ℃ for 30 minutes on a plate shaker/incubator. Color Reagent is then added to all wells and the plate is incubated for 10 minutes at 37 ℃ on a plate incubator/shaker. The absorbance is measured on a microplate reader at a wavelength of 600 nm for the measurement channel and 750 nm for the reference channel. Results are expressed as mg of total galactose per dL of whole blood.
Statement of Intended Use 5.
The SPOTCHECK Neonatal Total Galactose Microplate Reagent Kit is intended for the quantitative determination of the concentration of Total Galactose (galactose (Gal) + galactose-1-phosphate (Gal-1-P)) in whole blood saturated filter paper disks using a microplate absorbance reader or SPOTCHECK Pro. Measurements of Total Galactose are used primarily in the diagnosis and treatment of the hereditary disease galactosemia. This method is intended for in vitro diagnostic use as an aid in neonatal screening for increased concentrations of Total Galactose, and not for monitoring purposes.
Summary of the Technological Characteristics of the Device 6.
DEVICE COMPARISON
The most significant difference between the SPOTCHECK Neonatal Total Galactose Microplate Reagent Kit and the predicate device is the use of liquid calibrants with the proposed device versus dried blood spot calibrants with the predicate. Additionally, the proposed device is also intended for use on automated platforms while the predicate is intended for manual processing only. Both the proposed and predicate devices use
3
approximately the same reagent formulation and both use the same technology (spectrophotometric microplate reader) to determine total galactose concentration.
Neonatal patient dried blood specimens are punched into microplate wells, eluted and incubated with the same extraction solution on the proposed device as on the predicate device. The Enzyme and Coenzyme reagents are prepared and added as separate reagents on the proposed device, whereas they are combined immediately prior to use on the predicate. The final step in the reaction, the formation of the colored formazan, is the same in both devices.
The predicate device allows a time range for the extraction (45 - 120 minutes) and enzyme incubation (30 - 60 minutes) steps and specifies 5 minutes between color reagent addition and the absorbance measurement. The proposed device specifies the time required for the extraction (60 minutes) and enzyme incubation (30 minutes) steps and calls for 10 minutes between color reagent addition and the absorbance measurement.
| Comparator | SPOTCHECK Neonatal Total
Galactose Microplate Kit | Predicate Device |
|----------------------------------------------|------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Specimen collection,
handling and storage | Use standardized blood spot
collection cards; follow protocol
in CLSI LA4-A5 | Same collection, handling
and storage |
| Specimen | 1 x 1/8" dried blood spot (DBS)
disks | Same sample size, has second
protocol using 2 x 1/8" disks |
| Extraction and
incubation | In microplate, on combination
incubator/shaker | In microplate, on shaker |
| Extraction and
incubation temperature | 37 °C | 18-25 °C |
| Extraction time | 60 minutes | 45 - 120 minutes |
| Incubation time | 30 minutes | 30 - 60 minutes |
| Extraction Solution | 3% TCA | 3% TCA |
| Enzyme Reagent | Buffered Alkaline Phosphatase
and Galactose Dehydrogenase | Buffered Alkaline
Phosphatase, Galactose
Dehydrogenase and
Nicotinamide adenine
dinucleotide (NAD) |
| Coenzyme reagent | NAD | N/A (NAD included in
enzyme reagent, see above) |
| Color reagent | Buffered MTT + Methoxy PMS | Buffered MTT + Methoxy
PMS |
| Absorbance
measurement | 600 nm (750 nm reference) | 570 nm (690 nm reference) |
| Reporting units | mg/dL | mg/dL |
| Limit of quantitation | 1.4 mg/dL | 1.5 mg/dL |
| Range | 1.4 - 50 mg/dL | 1.5 mg/dL - 50 mg/dL |
Summary of SPOTCHECK Neonatal Total Galactose Microplate Kit and Predicate Device Comparison of Technological Characteristics
4
| Comparator | SPOTCHECK Neonatal Total
Galactose Microplate Kit | Predicate Device |
|--------------------------|------------------------------------------------------|-----------------------------------------------|
| Calibration | Liquid galactose standards | Dried blood spot standards |
| Clinical classification | Presumptive positive and
negative (normal) | Presumptive positive and
negative (normal) |
| Quality control material | Not provided with kit | DBS low, mid, and high
concentrations |
LINEARITY
The assay is linear in the range of 1.4 to 50 mg/dL, as confirmed by adherence to CLSI EP6-A: Evaluation of the Linearity of Ouantitative Measurement Procedures: A Statistical Approach: Approved Guideline. Responses of the standards give a correlation coefficient R2 > 0.995 using a 1st order curve from 0 to 50 mg/dL. Total galactose results 50 mg/dL are to be reported as such.
ANALYTICAL SENSITIVITY
The analytical sensitivity of the assay was determined by adherence to NCCLS EP 17-A Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline. The limit of detection (LoD) for Total Galactose utilizing manual processing is 1.4 mg/dL and utilizing SPOTCHECK PRO processing is 1.3 mg/dL. as calculated using the guidelines in NCCLS EP17-A protocol and with proportions of false positives (a) less than 0.1% and false negatives (B) less than 0.1%, based on 180 determinations. For ease of use when utilizing both processing options, the LoQ for SPOTCHECK Pro processing will be set at 1.4 mg/dL. The limit of blank (LoB) utilizing manual processing is 1.1 mg/dL and utilizing SPOTCHECK PRO processing is 0.9 mg/dL. To establish the LoQ. since an estimate of bias is not assured, the following goal for Total Error (TE) was used: "imprecision at any concentration greater than or equal to the LoO shall not exceed 20%". To evaluate imprecision within the data collected for this study (Sensitivity), %RSD was used as the metric. For both manual and SPOTCHECK PRO processing, %RSD is less than 20 for all levels that are at or above the LoO.
METHOD COMPARISON
Expected Values, Clinical Cutoff and Sample Classification Comparison
An exemplary normal range was established by analyzing 2037 (2036 for SPOTCHECK Pro) routine samples at a state screening laboratory using the SPOTCHECK Kit both manually and automated. The same specimens were analyzed using a legally-marketed predicate device. In addition, 51 manufactured samples elevated in Total Galactose were tested with both the proposed and predicate devices for the purpose of sample classification comparison.
To supplement the initial clinical comparison study 11 retrospective confirmed galactosemic newborn specimens were obtained from the Michigan Neonatal Biobank. The specimens were blindly added amidst presumptive negative patient specimens and data was collected in two runs on each device over the course of two days in the Quality Control laboratory at Astoria-Pacific. Inc. The supplemental study brought the total
5
number of neonatal specimens analyzed from 2037 to 2209 (2036 to 2208 for SPOTCHECK Pro). Tables of comparison for sample statistics and a summary of sample classification are provided below.
Data Summary
| Total Galactose (mg/dL) | Predicate Device | Proposed Device -
Manual | Proposed Device -
SPOTCHECK Pro |
|-------------------------|------------------|-----------------------------|------------------------------------|
| # of Observations | 2268 | 2268 | 2267 |
| Mean Value Observed' | 3.3 | 3.4 | 3.6 |
| Standard Deviation' | 4.7 | 5.2 | 5.3 |
| Range of the Data' | 1.5 - 48.0 | 1.4 - 49.6 | 1.4 - 43.1 |
| 99th Percentileii | 7.2 | 6.7 | 7.0 |
| 99.5th Percentileii | 8.8 | 8.5 | 8.9 |
'Results for these statistics only apply to those samples with results ≥LoQ (≥1.4 for Proposed and ≥1.5 for Predicate) and