(304 days)
Not Found
No
The device description and performance studies focus on standard enzymatic assays and automated liquid handling, with no mention of AI or ML algorithms for data analysis or interpretation.
No
This device is for in vitro diagnostic use, specifically for screening and diagnosis of galactosemia by measuring enzyme activity in blood samples. It does not provide direct treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Measurements of GALT enzyme activity 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 decreased levels of GALT enzyme activity."
No
The device description clearly outlines a "SPOTCHECK Neonatal GALT Microplate Reagent Kit" which involves chemical reagents and a "SPOTCHECK Pro" which is described as an "INSTRUMENT COMPONENTS: Tecan Freedom EVO and accessories necessary for assay." These are physical components, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states: "This method is intended for in vitro diagnostic use as an aid in neonatal screening for decreased levels of GALT enzyme activity..." and "The SPOTCHECK Pro is used for automated sample processing in the application of in vitro diagnostic assays."
- Specimen Type: The device analyzes "whole blood saturated filter paper disks" and "Specimens containing patient bodily substances". These are human specimens.
- Purpose: The purpose is to quantitatively determine GALT activity in these specimens, which is used "primarily in the diagnosis and treatment of the hereditary disease galactosemia" and as "an aid in neonatal screening". This directly relates to diagnosing or aiding in the diagnosis of a disease or condition.
- Device Description: The description details a laboratory assay process involving chemical reactions and absorbance measurements on patient samples.
All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
The SPOTCHECK Neonatal GALT Microplate Reagent Kit is for the quantitative determination of galactose-1-phosphate uridyltransferase, EC 2.7.7.12 (GALT), activity in whole blood saturated filter paper disks, using a microplate absorbance reader. Measurements of GALT enzyme activity 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 decreased levels of GALT enzyme activity, and not for monitoring purposes.
The SPOTCHECK Pro is used for automated sample processing in the application of in vitro diagnostic assays. Specimens containing patient bodily substances are introduced and analyzed in microtiter plates using qualitative/guantitative determination through absorbance measurements.
Product codes (comma separated list FDA assigned to the subject device)
KQP, JJQ
Device Description
The SPOTCHECK Neonatal GALT Microplate Reagent Kit - 60 Plate (Astoria-Pacific Part No. 81-4000-60K) is a galactose-1-phosphate uridyl transferase test system. Its contents include Substrate Color Reagent, Stock Standard, and Tris Buffer. Four enzyme mediated reactions are employed to determine GALT activity. The GALT enzyme converts galactose-1-phosphate to glucose-1-phosphate and concurrently converts UDP-glucose to UDP-galactose. Then, glucose-1-phosphate is converted to glucose-6-phosphate catalyzed by phosphoglucomutase. Next, glucose-6-phosphate is oxidized to 6-phosphogluconate with the concurrent reduction of NADP to NADPH, catalyzed by glucose-6-phosphate dehydrogenase. Finally, a tetrazolium salt, catalyzed by diaphorase, reacts with the NADPH to form a colored formazan product that is measured to yield GALT activity. Patient samples of whole blood collected on standardized filter paper are placed into wells of a 96-well microplate. A buffered enzyme mixture is added and the plate is incubated at 37 °C for 120 minutes on a plate shaker/incubator. Following incubation, an aliquot is transferred to a clean 96-well microplate, color reagent is added, color develops over 10 minutes, and absorbance is determined on a plate reader. A blank absorbance reading is made prior to color reagent addition to correct for endogenous sample color. The color developed is proportional to GALT activity. A standard curve prepared from a stock NADH solution quantitates results, expressed as units of GALT enzyme activity per gram of hemoglobin or U/g Hb.
The SPOTCHECK Pro (Astoria-Pacific Part No. 910-0500-00) is a galactose-1-phosphate uridyl transferase test system. Its instrument components include Tecan Freedom EVO® and accessories necessary for assay.
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 / Newborn
Intended User / Care Setting
Trained, qualified laboratory personnel.
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
AUTOMATED and MANUAL PERFORMANCE COMPARISON:
Sample Size: 128 newborn patient dried blood spot samples, dried blood spot controls manufactured to mimic newborn specimens, and dried specimens consisting of mixed adult blood. A total of 216 samples were analyzed using singlicate measurements for both devices.
Data Source: Newborn patient dried blood spot samples, dried blood spot controls, mixed adult blood dried specimens.
Annotation Protocol: N/A. Manual processing of the reagent kit was compared against the SPOTCHECK Pro automated platform. Same reagent preparations were used, and individual samples were punched and analyzed using each process on the same day over three days.
EXPECTED VALUES and DETERMINATION of CLINICAL CUTOFF:
Sample Size: 1752 routine samples and 53 known GALT deficient samples (controls, retrospective galactosemic neonates, and galactosemic non-neonates).
Data Source: Routine samples and known GALT deficient samples from a state screening laboratory.
Annotation Protocol: Samples analyzed using the SPOTCHECK Kit (automated on the SPOTCHECK Pro) and the predicate device. Specimens with results equal to or below the 0.5 and 0.25 percentiles were classified as deficient in GALT activity, or presumptive positive for galactosemia.
CLASSIFICATION of SAMPLES:
Sample Size: Patient samples and dried blood spot control samples. 1752 samples in the first table, 1805 in the second, and 1752 in the third and fourth.
Data Source: Patient samples, dried blood spot control samples.
Annotation Protocol: Performance evaluated against the predicate device according to CLSI EP9-A2: Method Comparison and Bias Estimation Using Patient Samples: Approved Guideline - Second Edition.
Screening Using Manual Processing:
Sample Size: 247 newborn patient dried blood spot samples, dried blood spot controls with newborn hematocrit, and dried specimens consisting of mixed adult blood. A total of 292 samples were analyzed using singlicate measurements for both devices.
Data Source: Newborn patient dried blood spot samples, dried blood spot controls, mixed adult blood dried specimens.
Annotation Protocol: An internal study was performed for manual comparison to the predicate device. A population of specimens that provided a large number of low GALT activity results was analyzed to ensure a high number of relevant screening classification comparisons.
PRECISION PERFORMANCE:
Sample Size: 80 data points at each of 4 levels for within-run and total precision for SPOTCHECK Kit (16 replicates on 1 run per day for 5 days). For predicate device, 20 data points for normal GALT activity levels (samples in duplicate during 10 separate runs).
Data Source: Samples at 4 different levels of GALT activity.
Annotation Protocol: Determined according to CLSI EP5-A2: Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline - Second Edition.
ANALYTICAL SPECIFICITY:
Sample Size: Not specified for each interference study, but implied to be sufficient for statistical analysis.
Data Source: Samples spiked with different interfering substances (γ globulin, Albumin, Bilirubin, Hemoglobin, Triglycerides, Sulfamethoxazole, Trimethoprim).
Annotation Protocol: Carried out according to CLSI EP7-A2: Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition.
Contributions from Hematocrit:
Sample Size: Three blood spot samples, each manufactured with three different levels of hematocrit (45%, 55%, and 65%), and for each, 6 replicates (n=6).
Data Source: Manufactured blood spot samples with deficient GALT, near the clinical cutoff, and normal GALT.
Annotation Protocol: Quantity of red blood cells adjusted prior to spotting on blood spot collection paper.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
LINEARITY:
Study Type: Linearity study
Sample Size: Not specified, but involved measurements in the range of 0.25 to 15 U/g Hb.
Key Results: The assay is non-linear (200 order regression) in the range of 0.25 to 15 U/g Hb. The calibration curve, established by the use of NADH standards, conforms to a 200 order regression from 0 to 15 U/g Hb. Results > 15 U/g Hb are reported as such.
ANALYTICAL SENSITIVITY:
Study Type: Analytical sensitivity determination
Sample Size: 300 measurements (60 blank and 240 low-level samples).
Key Results: Limit of detection (LoD) is 0.2 U/g Hb, and the limit of quantitation (LoQ) is 0.3 U/g Hb. LoB = 0.08 U/g Hb. The total error (TE, 3xSD) is less than the goal of 0.2 U/g Hb. A functional LoQ of 0.3 U/g Hb was established using a criterion of
§ 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
ASTORIA. PACIFIC
Neonatal GALT Microplate Reagent Kit
Name, Address of Contact Person 1.
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
.
Name of the Device 2.
Product Classification
Device Classification
Reagent Kit
| Regulation Number | 21 CFR 862.1315 |
|---|---|
| 510(k) Number | K102643 |
| Classification Panel | Clinical Chemistry |
| Product Code | KQP |
| Device Classification | Class II |
| Product Nomenclature | |
| Common Name | GALT (Galactose-1-phosphate uridyl transferase) |
| Screening Test | |
| Classification Name | Galactose-1-phosphate uridyl transferase test system |
| Proprietary Name | Astoria-Pacific SPOTCHECK® Neonatal GALT Microplate |
| Reagent Kit - 60 Plate | |
| Model Number | Astoria-Pacific Part No. 81-4000-60K |
| Instrument | |
| Regulation Number | 21 CFR 862.2300 |
| 510(k) Number | K102643 |
| Classification Panel | Clinical Chemistry |
| Product Code | JJO |
Class I
510(k) Summary
JUL 15 2011
1
510(k) Summary
Product Nomenclature
| Common Name | Photometer for clinical use |
|---|---|
| Classification Name | Colorimeter, photometer, spectrophotometer for clinical use |
| Proprietary Name | SPOTCHECK ProTM |
| Model Number | Astoria-Pacific Part No. 910-0500-00 |
3. Identification of the legally-marketed device for which substantial equivalence is claimed.
Product Classification
Reagent Kit
| Regulation Number
510(k) Number
Classification Panel
Product Code
Device Classification | 21 CFR 862.1315
K990827
Clinical Chemistry
KOP
Class II |
|-----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|
| | |
| Product Nomenclature | |
| Common Name | GALT (Galactose-1-phosphate uridyl transferase)
Screening Test |
| Classification Name | Galactose-1-phosphate uridy1 transferase test system |
| Proprietary Name | Bio-Rad Quantase Neonatal GALT Test |
| Model Number(s) | Bio-Rad Part No. 532-6000, 192 Test Kit |
| | Bio-Rad Part No. 532-6001, 960 Test Kit |
| Instrument | |
| Regulation Number | 21 CFR 862.2300 |
| 510(k) Number | K953710 |
| Classification Panel | Clinical Chemistry |
| Product Code | JJQ |
| Device Classification | Class I |
| Product Nomenclature | |
| Common Name | Photometer for clinical use |
| Classification Name | Colorimeter, photometer, spectrophotometer for clinical
use |
| Proprietary Name
Model Number(s) | Bio-Tek ELX808 Automated Microplate Readers
Part No. ELX808IUAP |
| Page 2 of 12 | |
2
510(k) Summary
Description of the Device 4.
SPOTCHECK Neonatal GALT Microplate Reagent Kit - 60 Plate
Astoria-Pacific Part No. 81-4000-60K Galactose-1-phosphate uridyl transferase test system
KIT CONTENTS:
Substrate Color Reagent Stock Standard Tris Buffer
Four enzyme mediated reactions are employed in the determination of GALT activity. The GALT enzyme catalyzes the conversion of galactose-1-phosphate to glucose-1phosphate and concurrently the conversion of UDP-glucose to UDP-galactose. Then, glucose-1-phosphate is converted to glucose-6-phosphate catalyzed by the enzyme phosphoglucomutase. Next, glucose-6-phosphate is oxidized to 6-phosphogluconate with the concurrent reduction of NADP to NADPH, catalyzed by glucose-6-phosphate dehydrogenase. Finally, a tetrazolium salt, catalyzed by diaphorase, reacts with the NADPH to form the product that is measured to yield GALT activity.
Image /page/2/Figure/8 description: This image shows a series of four chemical reactions. In the first reaction, Gal-1-P and UDP-Glu are converted to Glu-1-P and UDP-Gal, with GALT as the catalyst. In the second reaction, Glu-1-P is converted to Glu-6-P, with PGluM as the catalyst and Mg as a cofactor. In the third reaction, Glu-6-P and NADP are converted to 6-PG and NADPH, with G6PD as the catalyst and Mg as a cofactor. In the fourth reaction, NADPH and MTT are converted to Colored Formazan and NADP, with Diaphorase as the catalyst.
GALT activity is determined by measuring the colored formazan produced by the addition of the color reagent to the incubated blood/substrate mixture.
Patient samples of whole blood collected on standardized filter paper are placed into the wells of a standard 96 well microplate. A buffered enzyme mixture is added to each well and the plate is incubated at 37 °C for 120 minutes on a plate shaker/incubator. Following incubation, an aliquot of the mixture from each well is transferred to the corresponding wells on a clean 96 well microplate. Color reagent is added to each well, the color is developed over the course of 10 minutes, and the absorbance of each sample is
Page 3 of 12
3
determined on the plate reader. A blank absorbance reading is made prior to the addition of the color reagent to correct for endogenous sample color.
The color developed is proportional (1:1) to the GALT activity in the sample. A standard curve prepared from a stock NADH solution is used to quantitate the results. Results are expressed as units of GALT enzyme activity per gram of hemoglobin or U/g Hb. A unit is defined as the quantity of GALT enzyme that catalyzes the formation of one micromole of UDP-galactose per minute at 37 °C.
SPOTCHECK Pro
Astoria-Pacific Part No. 910-0500-00 Galactose-1-phosphate uridyl transferase test system
INSTRUMENT COMPONENTS:
Tecan Freedom EVO® and accessories necessary for assay
Statement of Intended Use 5.
The SPOTCHECK Neonatal GALT Microplate Reagent Kit is for the quantitative determination of galactose-1-phosphate uridyl transferase, EC 2.7.7.12 (GALT), activity in whole blood saturated filter paper disks, using a microplate absorbance reader. Measurements of galactose-1-phosphate uridyltransferase 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 newborn screening for decreased levels of GALT enzyme activity, and not for monitoring purposes.
The SPOTCHECK Pro is used for automated sample processing in the application of in vitro diagnostic assays. Specimens containing patient bodily substances are introduced and analyzed in microtiter plates using qualitative/quantitative determination through absorbance measurements.
These devices are intended for use by trained, qualified laboratory personnel.
Summary of the Technological Characteristics of the Device 6.
DEVICE COMPARISON
The most significant difference between the SPOTCHECK Neonatal GALT Microplate Reagent Kit and the predicate device is the use of a calibration curve with the SPOTCHECK Kit to quantify results. Additionally, the SPOTCHECK Kit is also intended for use on automated platforms. Both the proposed and predicate devices use approximately the same reagent formulation and both use the same technology (spectrophotometric microplate reader) to determine GALT activity.
4
Neonatal patient dried blood specimens are punched into microplate wells, eluted and incubated with approximately the same substrate and buffer system on the SPOTCHECK Kit as on the predicate device. On the SPOTCHECK Kit, the tetrazolium salt (MTT) is not introduced into the reagent scheme until the final chemical reaction, whereas on the predicate device the MTT is included in the incubation substrate at the start of the procedure. The final step in the reaction, the formation of the colored formazan, is the same in both devices.
The SPOTCHECK Kit has two additional enzymes in the incubation substrate that are not included on the predicate device. Galactose-6-phosphate dehydrogenase (G6PD) and phosphoglucomutase (PGluM) are normally present in clinical specimens, but may become damaged or destroyed if samples are exposed to excess heat or moisture during handling or if samples are stored at room temperature or above for extended periods of time. The two additional enzymes are included so that samples with degradation of G6PD or PGluM are not incorrectly classified as having deficient GALT activity.
| | SPOTCHECK Neonatal
GALT 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" punched dried blood
spot (DBS) | Same sample size |
| Incubation | In microplate, on combination
incubator/shaker | In covered or sealed
microplate, on
incubator/shaker |
| Incubation temperature | 37 °C | 37 °C |
| Incubation time | 2 hours (120 minutes) | 3 hours (180 minutes) |
| Substrate reagent | Buffered NADP + Gal-1-P +
UDP-Glu + G6PD + PGluM | Buffered NADP +
tetrazolium salt + Gal-1-P +
UDP-Glu + glucose-1,6-
diphosphate |
| Color reagent | Buffered MTT + diaphorase | Buffered diaphorase |
| Absorbance measurements
on microplate reader | 600 nm (750 nm reference) | 550 or 570 nm |
| Reporting units | U/g Hb | U/g Hb |
| Limit of quantitation | 0.3 U/g Hb | 0.64 U/g Hb |
| Range | 0.3 U/g Hb to 15 U/g Hb | Upper range not stated |
| Calibration | Liquid NADH standards | Factor multiplication |
| Clinical classification | Presumptive positive and
negative (normal) | Presumptive positive and
negative |
| Quality control material | DBS normal, deficient | DBS normal, deficient |
Summary of SPOTCHECK Neonatal GALT Microplate Kit and Predicate Device Comparison of Technological Characteristics
5
510(k) Summary
LINEARITY
The assay is non-linear (200 order regression) in the range of 0.25 to 15 U/g Hb. This correlation was confirmed by adherence to CLSI EP6-A: Evaluation of the Linearity of Ouantitative Measurement Procedures: A Statistical Approach; Approved Guideline. The calibration curve, established by the use of NADH standards, conforms to a 200 order regression from 0 to 15 U/g Hb. Results > 15 U/g Hb are reported as such.
ANALYTICAL SENSITIVITY
An overall analytical sensitivity of the assay was determined by adhering to CLSI EP17-A: Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline. The limit of detection (LoD), defined as the lowest amount of analyte in a sample that can be detected (although perhaps not accurately quantifiable), is 0.2 U/g Hb and the limit of quantitation (LoQ) is 0.3 U/g Hb. The LoD is determined consistent with the guidelines in CLSI EP17-A protocol and with proportions of false positives (a) less than 0.3% and false negatives (B) less than 0.3%, based on 300 measurements, consisting of 60 blank and 240 low-level samples; limit of blank (LoB) = 0.08 U/g Hb. The total error (TE, 3xSD) is less than the goal of 0.2 U/g Hb, assuming that there is no bias due to the unavailability of standard reference materials. Therefore, according to the guidelines in CLSI EP17-A, the LoD = LoQ. However, a functional LoQ of 0.3 U/g Hb was established using a criterion of "Routine neonatal screening by the state DOH classified all but one of these specimens (as well as the specimens classified as negative) to be presumptive negative for galactosemia. The laboratory classified the one specimen as having partial GALT activity.
2 Routine neonatal screening by the state DOH classified all but one of these specimens (as well as the specimens classified as negative) to be presumptive negative for galactory classified the one specimen as having partial GALT activity.
8
Screening Using Manual Processing
An internal study was performed for manual comparison to the predicate device. Newborn patient dried blood spot samples (n = 247), dried blood spot controls with newborn hematocrit, and dried specimens consisting of mixed adult blood were analyzed using both the SPOTCHECK Kit and the predicate device. A total of 292 samples were analyzed using singlicate measurements for both devices. A population of specimens that provided a large number of low GALT activity results was analyzed to ensure a high number of relevant screening classification comparisons.
| GALT {All Specimens} | Predicate Device | SPOTCHECK |
|---|---|---|
| No. of Observations (in range) | 265 | 265 |
| Mean Value | 4.8 U/g Hb | 5.2 U/g Hb |
| Standard Deviation | 2.4 | 2.5 |
| Range of the Data | 0.6 to 12.6 U/g Hb | 1.1 to 14.3 U/g Hb |
Statistics include only results within measuring range of both devices.
| Deficient GALT Activity
(Presumptive Positive) | $\u2264$ 2.3 U/g
Hb | $\u2264$ 3.2 U/g Hb (0.5th percentile)
and
$\u2264$ 2.9 U/g Hb (0.25th percentile) |
|---------------------------------------------------|------------------------|------------------------------------------------------------------------------------------|
| Normal GALT Activity (Negative) | > 2.3 U/g
Hb | > 3.2 U/g Hb (0.5th)
and
2.9 U/g Hb (0.25th) |
| Predicate Device | ||||
|---|---|---|---|---|
| Positive | Negative | Total | ||
| SPOTCHECK | Positive | 60 | 27 | 87 |
| Negative | 2 | 203 | 205 | |
| Total | 62 | 230 | 292 | |
| Percent positive agreement: (60/62) = 96.7% |
| Predicate Device | ||||
|---|---|---|---|---|
| Positive | Negative | Total | ||
| SPOTCHECK | Positive | 58 | 16 | 74 |
| Negative | 4 | 214 | 218 | |
| Total | 62 | 230 | 292 | |
| Percent positive agreement: (58/62) = 93.5% | ||||
| Percent negative agreement: (214/230) = 93.0% |
The SPOTCHECK GALT in vitro diagnostic kit demonstrated a high degree of correlation to specimens classified positive by the predicate device. Additionally, 10 specimens known to be deficient in GALT activity (analyzed in an unbiased manner) were correctly classified.
This evaluation complements the study demonstrating equivalent performance between manual and automated processing. Combined, they demonstrate safety and effectiveness of the new GALT screening method, using manual or automated specimen analysis.
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PRECISION PERFORMANCE
Within-run and total precision for the SPOTCHECK Kit were determined according to CLSI EP5-A2: Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline - Second Edition. Samples at 4 different levels of GALT activity were analyzed using 16 replicates on 1 run per day for 5 days (2 distinct calibration curves on 2 plates); a total of 80 data points at each level were collected. Within-run and total precision using the predicate device for normal GALT activity levels was determined by analyzing samples in duplicate during 10 separate runs (data reported below was copied from product insert). The method used to determine precision of deficient and partial activity GALT samples in the predicate device was not stated.
Within-Run Precision, Sr SPOTCHECK Neonatal GALT Kit
| (Manual, n = 80) | ||||
|---|---|---|---|---|
| Activity | ||||
| (U/g Hb) | Deficient | Partial | Near | |
| cutoff | Normal | |||
| Mean | 0.45 | 1.3 | 2.4 | 6.7 |
| S.D. | 0.037 | 0.087 | 0.20 | 0.55 |
| C.V. | 8.1% | 6.5% | 8.3% | 8.2% |
| Activity
(U/g Hb) | Deficient | Partial | Near
cutoff | Normal |
|----------------------|-----------|---------|----------------|--------|
| Mean | 0.60 | 1.3 | 2.4 | 6.1 |
| S.D. | 0.046 | 0.081 | 0.16 | 0.40 |
| C.V. | 7.8% | 6.2% | 6.7% | 6.6% |
(Automated on the SPOTCHECK Pro, n = 80)
Predicate Device
| (Manual, n = 20) | |||
|---|---|---|---|
| Activity | |||
| (U/g Hb) | Normal | Normal | Normal |
| Mean | 3.5 | 3.6 | 5.0 |
| S.D. | 0.15 | 0.27 | 0.37 |
| C.V. | 4.3% | 12% | 7.4% |
Total Precision, ST
SPOTCHECK Neonatal GALT Kit
(Manual, n = 80)
| Activity
(U/g Hb) | Deficient | Deficient | Near
cutoff | Normal |
|----------------------|-----------|-----------|----------------|--------|
| Mean | 0.45 | 1.3 | 2.4 | 6.7 |
| S.D. | 0.05 | 0.12 | 0.22 | 0.65 |
| C.V. | 11% | 9.2% | 9.2% | 9.7% |
10
| Automated on the SPOTCHECK Pro, n = 80) | ||||
|---|---|---|---|---|
| Activity | ||||
| (U/g Hb) | Deficient | Partial | Near | |
| cutoff | Normal | |||
| Mean | 0.60 | 1 .3 | 24 | 6.1 |
| S.D. | 0.063 | 0.095 | 0.17 | 0.41 |
| C.V. | 11% | 7.3% | 7.1% | 6.7% |
Total Precision, Sr (continued)
Predicate Device
(Manual, n = 20)
| Activity
| (U/g Hb) | Partial" | Normal | Normal | Normal |
|---|---|---|---|---|
| Mean | 1.8 | 3.5 | 3.6 | 5.0 |
| S.D. | 0.45 | 0.37 | 0.43 | 0.40 |
| C.V. | 23% | 11% | 12% | 8.0% |
"(Number of samples (n) is not reported.)
The results of the precision study demonstrate that the SPOTCHECK Neonatal GALT Microplate Reagent Kit, at a minimum, exhibits comparable precision performance to that reported in the predicate device insert. Additionally, performance is similar whether the SPOTCHECK kit is processed manually or with automation.
ANALYTICAL SPECIFICITY
The study of potential interfering substances when using the SPOTCHECK Neonatal GALT Microplate Reagent Kit was carried out according to CLSI EP7-A2: Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition.
| Interference Evaluated | SPOTCHECK Neonatal GALT
Microplate Kit | Predicate Device |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| γ globulin (protein) | Up to 6000 mg/dL showed no
statistically significant interference;
minor increases in GALT were
observed near the cutoff, but a
deficient neonate would not be
classified as normal | up to 2500 mg/dL
showed no significant
interference |
| Albumin (protein) | Up to 6000 mg/dL showed no
statistically significant interference;
minor increases in GALT were
observed near the cutoff, but a
deficient neonate would not be
classified as normal | not evaluated |
| Bilirubin, conjugated | Up to 28.8 mg/dL showed no
statistically or clinically significant
interference | up to 40 mg/dL showed
no significant
interference |
| Bilirubin, unconjugated | Up to 20 mg/dL showed no | up to 40 mg/dL showed |
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11
| statistically or clinically significant | no significant | |
|---|---|---|
| interference | interference | |
| Hemoglobin (Hb) | Up to 200 mg/dL showed a | not evaluated |
| statistically significant decrease in | ||
| GALT activity, which could result | ||
| in a false positive near the cutoff | ||
| Triglycerides | Up to 3270 mg/dL showed no | up to 1000 mg/dL |
| statistically or clinically significant | showed no significant | |
| interference | interference | |
| Sulfamethoxazole | Up to 400 ug/mL showed no | not evaluated |
| (SMX) | statistically or clinically significant | |
| interference | ||
| Trimethoprim (TMP) | Up to 40 ug/mL showed no | not evaluated |
| statistically or clinically significant | ||
| interference |
Contributions from Hematocrit
To determine any possible effects on the performance of the Astoria-Pacific, Inc. SPOTCHECK Neonatal GALT Microplate Reagent due to varying blood hematocrit, three blood spot samples were manufactured, one with deficient GALT, one near the clinical cutoff, and one with normal GALT. Within each of the three blood spot samples, three different levels of hematocrit (45%, 55% and 65%) were achieved by adjusting the quantity of red blood cells prior to spotting on blood spot collection paper.
| Hematocrit % | Deficient (n = 6) | Near Cutoff (n = 6) | Normal (n = 6) |
|---|---|---|---|
| 45 | 0.43 U/g Hb | 2.4 U/g Hb | 5.4 U/g Hb |
| 55 | 0.55 U/g Hb | 2.7 U/g Hb | 6.9 U/g Hb |
| 65 | 0.72 U/g Hb | 3.3 U/g Hb | 8.3 U/g Hb |
GALT activity resides in the red blood cells, so it is expected that varying hematocrit will lead to varying GALT response. Samples with lower hematocrit levels had lower GALT activity and samples with higher hematocrit levels had GALT activity. Differences in hematocrit had a statistically significant effect on samples with low GALT activity, however there is no indication that a sample deficient in GALT activity would be misclassified as normal (false negative) due to varying hematocrit levels.
7. Determination of Substantial Equivalency
Based on the performance characteristics and comparison data, the SPOTCHECK Kit is safe, effective, and substantially equivalent to the legally-marketed predicate device. The indications for use are essentially the same for the SPOTCHECK Neonatal GALT Microplate Reagent Kit and the predicate device. Technological characteristics are very similar to the predicate device and there is sufficient evidence that demonstrates that the differences do not adversely affect the safety and effectiveness of the SPOTCHECK Kit.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/12/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 a caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff entwined by two snakes and topped with wings.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Jul. 15 2011
Astoria-Pacific, Inc. c/o Mr. Jason C. Reynolds Director of Research & Development 15130 SE 82nd Dr. Clackamas. OR 97015
રિભ: K102643 Trade Name: SPOTCHECK Neonatal GALT Microplate Reagent Kit, SPOTCHECK Pro Regulation Number: 21 CFR §862.1315 Regulation Name: Galactose-1-Phosphate Uridyl Transferase test system Regulatory Class: Class II Product Codes: KQP, JJQ Dated: July 8. 2011 Received: July 11, 2011
Dear Mr. Reynolds:
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, 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-fremember (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
CJC.
Courtney Harper. Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
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Enclosure
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Indications for Use Form
510(k) Number: K102643
Device Name:
Indications for Use:
The SPOTCHECK Neonatal GALT Microplate Reagent Kit is for the quantitative determination of galactose-1-phosphate uridyItransferase, EC 2.7.7.12 (GALT), activity in whole blood saturated filter paper disks, using a microplate absorbance reader. Measurements of GALT enzyme activity 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 decreased levels of GALT enzyme activity, and not for monitoring purposes.
This device is intended for use by trained, qualified laboratory personnel.
| Prescription Use
X
(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use
(21 CFR 801 Subpart C) |
| ------------------------------------------------------ | -------- | ------------------------------------------------ |
|---|
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C. Benam
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K102643
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Indications for Use Form
510(k) Number: K102643
Device Name: SPOTCHECK Pro™
Indications for Use:
The SPOTCHECK Pro is used for automated sample processing in the application of in vitro diagnostic assays. Specimens containing patient bodily substances are introduced and analyzed in microtiter plates using qualitative/guantitative determination through absorbance measurements.
This device and assays are intended for use by trained, qualified laboratory personnel.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
| Over-The-Counter Use | |
|---|---|
| (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C. Benam
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
4-102643 510(k)________________________________________________________________________________________________________________________________________________________________________
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