(435 days)
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.
The SPOTCHECK Neonatal Total Galactose Microplate Reagent Kit is a galactose test system. It includes Extraction Solution, Enzyme Reagent, Coenzyme Reagent, Color Reagent, and Stock Standard. Total Galactose is measured colorimetrically following the completion of two enzyme assisted reactions and the color formation reaction. Patient samples of whole blood collected on standardized filter paper are placed into the wells of a 96 well filtration microplate. Extraction solution is added and samples are eluted and incubated. The contents are filtered into a clean flat-bottom microplate. Enzyme Reagent and Coenzyme Reagent are added and the plate is incubated. Color Reagent is then added and the plate is incubated. 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.
The Astoria-Pacific SPOTCHECK® Neonatal Total Galactose Microplate Reagent Kit is a diagnostic device for quantitative determination of Total Galactose (Galactose + Galactose-1-Phosphate) in whole blood samples collected on filter paper disks. This information is gleaned from the provided 510(k) summary (K121101).
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary compares the performance of the SPOTCHECK Neonatal Total Galactose Microplate Reagent Kit to a legally marketed predicate device (Accuwell Total Galactose Model No. 6020-20 EGAL, 2000 Test Kit). The criteria for acceptance are primarily demonstrated through substantial equivalence to the predicate device in various analytical performance characteristics.
| Acceptance Criterion | Predicate Device Claim | SPOTCHECK Neonatal Total Galactose Microplate Reagent Kit Performance (Manual Process) | SPOTCHECK Neonatal Total Galactose Microplate Reagent Kit Performance (SPOTCHECK Pro Process) |
|---|---|---|---|
| Limit of Quantitation (LoQ) | 1.5 mg/dL | 1.4 mg/dL | 1.4 mg/dL (Note: LoD for SPOTCHECK Pro is 1.3 mg/dL, LoQ set to 1.4 mg/dL for ease of use) |
| Range | 1.5 mg/dL - 50 mg/dL | 1.4 mg/dL - 50 mg/dL | 1.4 mg/dL - 50 mg/dL |
| Linearity (Correlation Coefficient R²) | Not explicitly stated (implied by comparison of range) | > 0.995 (from 0 to 50 mg/dL) | > 0.995 (from 0 to 50 mg/dL) |
| Analytical Sensitivity (Limit of Detection, LoD) | Not explicitly stated | 1.4 mg/dL | 1.3 mg/dL |
| Clinical Classification (Presumptive Positive / Negative Agreement) | Not explicitly stated for specific agreement percentage, but classification is "presumptive positive and negative (normal)" | Classification results between predicate and SPOTCHECK reagent kits were substantially equivalent. | Classification results between predicate and SPOTCHECK reagent kits were substantially equivalent. |
| Precision (Total CV) - Normal level | 9.6% (at 6.1 mg/dL) | 9.8% (at 3.5 mg/dL) | 8.2% (at 3.3 mg/dL) |
| Precision (Total CV) - Near Cutoff level | 7.8% (at 10.4 mg/dL) | 7.7% (at 10.0 mg/dL) | 6.5% (at 10.2 mg/dL) |
| Precision (Total CV) - Galactosemic level | 8.0% (at 29.4 mg/dL) | 4.8% (at 31.3 mg/dL) | 5.1% (at 33.1 mg/dL) |
| Interference (γ globulin up to 6000 mg/dL) | No significant interference | No statistically significant interference | Not explicitly stated, implied to be same as manual |
| Interference (Albumin up to 6000 mg/dL) | No significant interference (up to 10000 mg/dL) | No statistically significant interference | Not explicitly stated, implied to be same as manual |
| Interference (Bilirubin, conjugated up to 20 mg/dL) | No significant interference | No statistically or clinically significant interference | Not explicitly stated, implied to be same as manual |
| Interference (Bilirubin, unconjugated up to 20 mg/dL) | No significant interference | No statistically or clinically significant interference | Not explicitly stated, implied to be same as manual |
| Interference (Hemoglobin up to 200 mg/dL) | No significant interference (up to 20000 mg/dL) | No statistically or clinically significant increase | Not explicitly stated, implied to be same as manual |
| Interference (Lipid up to 2700 mg/dL) | No significant interference | Statistically significant interference at low (normal) concentrations; not clinically significant (up to 3264 mg/dL) | Not explicitly stated, implied to be same as manual |
| Interference (Sulfamethoxazole (SMX) up to 4 mg/dL) | Not evaluated | No statistically or clinically significant interference | Not explicitly stated, implied to be same as manual |
| Interference (Trimethoprim (TMP) up to 4 mg/dL) | Not evaluated | Statistically significant interference at low (normal) concentrations; not clinically significant | Not explicitly stated, implied to be same as manual |
| Interference (Fructose up to 25 mg/dL) | No statistically or clinically significant interference | Statistically significant interference at low (normal) concentrations; not clinically significant | Not explicitly stated, implied to be same as manual |
| Interference (Glucose up to 1200 mg/dL) | No statistically or clinically significant interference | No statistically or clinically significant interference | Not explicitly stated, implied to be same as manual |
| Interference (Ascorbate up to 3 mg/dL) | No statistically or clinically significant interference | No statistically or clinically significant interference (up to 6 mg/dL) | Not explicitly stated, implied to be same as manual |
| Interference (Mannose up to 5 mg/dL) | No statistically or clinically significant interference | No statistically or clinically significant interference | Not explicitly stated, implied to be same as manual |
| Interference (Glutathione up to 60 mg/dL) | No statistically or clinically significant interference | Statistically significant interference at low (normal) concentrations and increased response at all concentrations, which could result in a false positive | Not explicitly stated, implied to be same as manual |
Study Proving Acceptance Criteria:
The studies described in the 510(k) summary were primarily focused on demonstrating "substantial equivalence" of the SPOTCHECK Neonatal Total Galactose Microplate Reagent Kit to a legally marketed predicate device. This is the common pathway for 510(k) clearances. The acceptance criteria are "met" if the new device performs similarly and safely to the predicate, accounting for any differences.
2. Sample Sizes Used for the Test Set and Data Provenance
-
Method Comparison (Clinical Comparison Study):
- Initial routine samples: 2037 (manual method) and 2036 (SPOTCHECK Pro method).
- Manufactured elevated samples: 51.
- Supplemental retrospective confirmed galactosemic newborn specimens: 11 (from Michigan Neonatal Biobank).
- Total Test Set for Clinical Comparison:
- Manual processing: 2037 + 51 + 11 = 2099 samples (with an overall total including the supplemental study given as 2209).
- SPOTCHECK Pro processing: 2036 + 51 + 11 = 2098 samples (with an overall total including the supplemental study given as 2208).
- Data Provenance: Routine samples were analyzed at a "state screening laboratory." The 11 confirmed galactosemic newborn specimens were obtained retrospectively from the "Michigan Neonatal Biobank." This indicates that the data is predominantly retrospective and originates from multiple sources/locations within the US.
-
Precision Performance:
- For the proposed device (SPOTCHECK Kit, both manual and SPOTCHECK Pro): 80 replicates for each of the three concentrations (Normal, Near Cutoff, Galactosemic). This implies 3 concentrations * 80 replicates = 240 measurements for each processing method.
- For the predicate device: 40 replicates for each of four concentrations. This implies 4 concentrations * 40 replicates = 160 measurements.
-
Analytical Sensitivity (LoD/LoQ): 180 determinations were used to calculate LoD.
-
Linearity and Analytical Specificity: Sample sizes are not explicitly stated as specific numbers of unique patient samples but rather as "responses of the standards" for linearity and "interference evaluated" with corresponding concentrations for specificity.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The provided document does not mention the use of "experts" in the traditional sense (e.g., radiologists, pathologists) to establish ground truth for this diagnostic kit.
- For the clinical comparison study, the "ground truth" for the routine samples was likely based on their classification as "routine" and the results from a legally marketed predicate device.
- For the 51 manufactured elevated samples, the "ground truth" was established by their controlled, high Total Galactose concentration during manufacturing.
- For the 11 retrospective confirmed galactosemic newborn specimens, the "ground truth" was established by their prior diagnosis of galactosemia, likely through standard clinical and laboratory diagnostic procedures (which would be the "gold standard" for the disease).
Therefore, there were no human experts forming a consensus for the test set ground truth in the way described for imaging or subjective assessment devices. The ground truth was based on the predicate device's results, manufacturing specifications, or established clinical diagnoses.
4. Adjudication Method for the Test Set
Given that the ground truth was largely based on a predicate device, manufacturing, or existing clinical diagnoses, there was no explicit adjudication method (like 2+1 or 3+1 consensus) described for resolving discrepancies in measurements or classifications. The study likely focused on agreement/correlation between the new device and the established values/predicate.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is typically associated with imaging devices where human readers interpret results, and the AI's impact on reader performance is evaluated. This device is an in vitro diagnostic reagent kit, and its performance is assessed analytically and by comparison to a predicate device and known values, not by human reader interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone performance evaluation was done. The device's performance characteristics (LoQ, LoD, range, linearity, precision, analytical specificity) were assessed directly through laboratory studies, both when processed manually and using the "SPOTCHECK Pro" automated system. These are evaluations of the algorithm/reagent system itself, independent of interpretation by human clinicians for diagnostic purposes. The device generates a quantitative numerical result.
7. Type of Ground Truth Used
The types of "ground truth" used include:
- Predicate Device Results: For routine samples in the method comparison, the results from the legally marketed predicate device served as the comparative ground truth.
- Known Concentrations/Manufacturing Specifications: For manufactured samples with elevated Total Galactose and the samples used in linearity, precision, and interference studies, the ground truth was the known, spiked, or formulated concentrations.
- Clinical Diagnosis/Outcomes Data: For the 11 retrospective confirmed galactosemic newborn specimens, the ground truth was their established clinical diagnosis of galactosemia.
8. Sample Size for the Training Set
The document is a 510(k) summary for a reagent kit that measures an analyte. This type of device does not typically involve "training sets" in the context of machine learning or AI algorithms that learn from data. Therefore, the concept of a "training set" as it applies to AI/ML is not relevant here, and no training set size is mentioned. The device's performance is based on chemical reactions and spectrophotometric measurements, not on learning from a dataset.
9. How the Ground Truth for the Training Set Was Established
As noted above, the concept of a "training set" does not apply to this type of diagnostic reagent kit. Therefore, the establishment of ground truth for a non-existent training set is not applicable.
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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
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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.
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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
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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 TotalGalactose Microplate Kit | Predicate Device |
|---|---|---|
| Specimen collection,handling and storage | Use standardized blood spotcollection cards; follow protocolin CLSI LA4-A5 | Same collection, handlingand storage |
| Specimen | 1 x 1/8" dried blood spot (DBS)disks | Same sample size, has secondprotocol using 2 x 1/8" disks |
| Extraction andincubation | In microplate, on combinationincubator/shaker | In microplate, on shaker |
| Extraction andincubation 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 Phosphataseand Galactose Dehydrogenase | Buffered AlkalinePhosphatase, GalactoseDehydrogenase andNicotinamide adeninedinucleotide (NAD) |
| Coenzyme reagent | NAD | N/A (NAD included inenzyme reagent, see above) |
| Color reagent | Buffered MTT + Methoxy PMS | Buffered MTT + MethoxyPMS |
| Absorbancemeasurement | 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
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| Comparator | SPOTCHECK Neonatal TotalGalactose Microplate Kit | Predicate Device |
|---|---|---|
| Calibration | Liquid galactose standards | Dried blood spot standards |
| Clinical classification | Presumptive positive andnegative (normal) | Presumptive positive andnegative (normal) |
| Quality control material | Not provided with kit | DBS low, mid, and highconcentrations |
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 <1.4 mg/dL and >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
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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 < high calibrant (50 mg/dL for Proposed and Predicate)
iiCutoffs are based on routine neonatal specimens only
Specimens with results greater than the 99 and 99.5 percentiles were classified as presumptive positive for galactosemia, and require follow-up testing according to institutional, local, state, regional, and/or national guidelines or regulations. The same criteria were used for both the proposed device and predicate device. Classification results between the predicate and the SPOTCHECK reagent kits, whether processed manually or using the SPOTCHECK Pro, were substantially equivalent.
PRECISION PERFORMANCE
Within-run and total precision for the proposed device were determined according to CLSI EP5-A2: Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline - Second Edition. Evaluation of precision utilized samples that were prepared from whole blood, with hematocrit adjusted to 55%, and spiked with analyte at three different concentrations (identified as "normal"), "near cutoff" and "galactosemic"). Samples were analyzed over five days, one run per day, sixteen replicates of each sample per run. Within each run two calibration curves were used, each curve was used to quantify half of the replicates for each sample. This was done to capture variation in calibration as a potential source of imprecision. Within-run and total precision using the predicate device was determined by analyzing samples in duplicate during 20 separate runs (data reported for the predicate was copied from product insert).
| TGal - Manual | Normal | Near Cutoff | Galactosemic |
|---|---|---|---|
| n (# of observations) | 80 | 80 | 80 |
| Mean (mg/dL) | 3.5 | 10.0 | 31.3 |
| Sr (within-run precision) | 0.291 | 0.640 | 1.401 |
| C.V. (within-run) | 8.3 | 6.4 | 4.5 |
| B (daily mean precision) | 0.194 | 0.453 | 0.661 |
| ST (total precision) | 0.342 | 0.768 | 1.509 |
| C.V. (total) | 9.8 | 7.7 | 4.8 |
Precision Tables
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| TGal - SPOTCHECK Pro | Normal | Near Cutoff | Galactosemic |
|---|---|---|---|
| n (# of observations) | 80 | 80 | 80 |
| Mean (mg/dL) | 3.3 | 10.2 | 33.1 |
| Sr (within-run precision) | 0.249 | 0.593 | 1.465 |
| C.V. (within-run) | 7.5 | 5.8 | 4.4 |
| B (daily mean precision) | 0.122 | 0.324 | 0.937 |
| ST (total precision) | 0.270 | 0.659 | 1.700 |
| C.V. (total) | 8.2 | 6.5 | 5.1 |
Precision Tables (continued)
| TGal - Predicate (manual) | CDC 721 | CDC 722 | CDC 723 | CDC 724 |
|---|---|---|---|---|
| n (# of observations) | 40 | 40 | 40 | 40 |
| Mean (mg/dL) | 6.1 | 10.4 | 14.9 | 29.4 |
| Sr (within-run precision) | 0.5 | 0.7 | 0.7 | 1.7 |
| C.V. (within-run) | 8.2 | 6.7 | 4.7 | 5.8 |
| B (daily mean precision) | 0.5 | 0.6 | 1.0 | 2.1 |
| Sr (total precision) | 0.6 | 0.8 | 1.1 | 2.4 |
| C.V. (total) | 9.6 | 7.8 | 7.5 | 8.0 |
The results of the precision study demonstrate that the SPOTCHECK Neonatal Total Galactose 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 Total Galactose Microplate Reagent Kit was carried out according to CLSI EP7-A2: Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition.
| Interference Evaluated | SPOTCHECK Neonatal TotalGalactose Microplate Kit | Predicate DeviceClaims |
|---|---|---|
| γ globulin (protein) | Up to 6000 mg/dL showed nostatistically significant interference | Up to 6000 mg/dL showedno significant interference |
| Albumin (protein) | Up to 6000 mg/dL showed nostatistically significant interference | Up to 10000 mg/dL showedno significant interference |
| Bilirubin, conjugated | Up to 20 mg/dL showed nostatistically or clinically significantinterference | Up to 20 mg/dL showed nosignificant interference |
| Bilirubin, unconjugated | Up to 20 mg/dL showed nostatistically or clinically significantinterference | Up to 20 mg/dL showed nosignificant interference |
| Hemoglobin (Hb) | Up to 200 mg/dL showed nostatistically or clinically significantincrease | Up to 20000 mg/dL showedno significant interference |
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| Interference Evaluated | SPOTCHECK Neonatal TotalGalactose Microplate Kit | Predicate DeviceClaims |
|---|---|---|
| Lipid | Up to 3264 mg/dL showedstatistically significant interferenceat low (normal) concentrations; theresult is not clinically significant | Up to 2700 mg/dL showedno significant interference |
| Sulfamethoxazole (SMX) | Up to 4 mg/dL showed nostatistically or clinically significantinterference | Not evaluated |
| Trimethoprim (TMP) | Up to 4 mg/dL showed statisticallysignificant interference at low(normal) concentrations; the result isnot clinically significant | Not evaluated |
| Fructose | Up to 25 mg/dL showed statisticallysignificant interference at low(normal) concentrations; the result isnot clinically significant | Up to 25 mg/dL showed nostatistically or clinicallysignificant interference |
| Glucose | Up to 1200 mg/dL showed nostatistically or clinically significantinterference | Up to 1200 mg/dL showedno statistically or clinicallysignificant interference |
| Ascorbate | Up to 6 mg/dL showed nostatistically or clinically significantinterference | Up to 3 mg/dL showed nostatistically or clinicallysignificant interference |
| Mannose | Up to 5 mg/dL showed nostatistically or clinically significantinterference | Up to 5 mg/dL showed nostatistically or clinicallysignificant interference |
| Glutathione | Up to 60 mg/dL showed statisticallysignificant interference at low(normal) concentrations andincreased response at allconcentrations, which could result ina false positive | Up to 60 mg/dL showed nostatistically or clinicallysignificant interference |
7. Determination of Substantial Equivalency
Based on the performance characteristics and comparison data, the proposed device is safe, effective, and substantially equivalent to the legally-marketed predicate device. The indications for use are fundamentally the same for the SPOTCHECK Neonatal Total Galactose Microplate Reagent Kit and the predicate device. Technological and performance 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 proposed device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/8/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo consists of two main elements: a stylized symbol resembling a bird in flight and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The symbol is composed of three curved lines that suggest the shape of a bird, and the text is written in a sans-serif font.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 20, 2013
Astoria-Pacifica, Inc. C/O Charles Peterson President 15130 S.E. 82nd Drive P.O. Box 830 CLACKAMAS OR 97015-0830
Re: K121101
Trade/Device Name: SPOTCHECK Neonatal Total Galactose Microplate Reagent Kit Regulation Number: 21 CFR 862.1310
Regulation Name: Galactose test system
Regulatory Class: I. exceeds the limitation to exemption in 862.9(c)(2) Product Code: JIA Dated: June 7, 2013 Received: June 11, 2013
Dear Mr. Peterson:
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-andadulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2—Mr. Peterson
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Carol C. Benson -S for
Courtney H. Lias, Ph.D. Director, Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use Form
510(k) Number (if known): K121101
Device Name: SPOTCHECK® Neonatal Total Galactose Microplate Reagent Kit
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.
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) J
Yung W. @gan -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
K121101 510(k)
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§ 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.