(274 days)
This method is for the semi-quantitative determination of biotinidase, EC 3.5.1.12, activity in dried whole blood spots using a spectrophotometer. Measurement of biotinidase activity is primarily for the diagnosis and treatment of biotinidase deficiency in newborns. This method is intended for in vitro diagnostic use in screening for decreased levels of biotinidase activity and not for monitoring purposes.
Biotinidase activity is determined by measuring the color that develops from p-Aminobenzoic Acid (PABA) after PABA is released from Biotinyl-p-Aminobenzoate (Biotin-PAB). Samples with biotinidase activity develop a purple color. Samples without biotinidase activity remain straw-colored. Patient samples of whole blood collected on standardized filter paper are eluted in a standard 96 well microplate. The plate is incubated with Biotin-PAB in a buffer at 37℃ for 240 minutes on a combination incubator/shaker. Following incubation, TCA is added to the sample mixture and the resulting precipitate is removed through filtration. The PABA in the filtrate is subsequently diazotized and coupled to a napthol derivative to form an azo dye by the successive addition of sodium nitrite, acidic ammonium sulfamate and finally, N-1-naphthylethylenediamine dihydrochloride (NED). The azo dye is measured colorimetrically at 550 nm on a commercial microplate absorbance reader with a reference measurement at 690 mm.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
The document does not explicitly present a formal "acceptance criteria" table with pre-defined thresholds for performance that the new device must meet. Instead, it compares the performance of the new device (SPOTCHECK Biotinidase Microplate Reagent Kit) against a legally marketed predicate device (K010844 Biotinidase Kit, 50-Hour) to demonstrate substantial equivalence, implying that performance comparable to the predicate device is the "acceptance criteria."
However, we can infer some criteria and report the device's performance based on the provided data:
| Acceptance Criterion (Inferred from Predicate Performance or Standards) | SPOTCHECK Biotinidase Microplate Reagent Kit Reported Performance | Notes / Comparisons to Predicate |
|---|---|---|
| Linearity (Correlation Coefficient) | ≥ 0.999 (typical) | Achieved with PABA standards ranging from 0 to 200 MRU. Also deemed linear over 5 to 213 MRU, adhering to CLSI EP6-A. Predicate device also uses calibration. |
| Sensitivity (Limit of Blank - LoB) | 2 MRU | Determined using CLSI EP17-A protocol. |
| Sensitivity (Limit of Detection - LoD) | 3 MRU | Determined using CLSI EP17-A protocol. "Correlates well with the sensitivity of the predicate device." LoQ = LoD. |
| Clinical Cutoff for Profound Deficiency | 10% mean activity of population | "Same for both devices." Each lab must determine its own range. |
| Clinical Cutoff for Partial Activity | 37% mean activity of population | "Same for both devices." Each lab must determine its own range. All samples below this require follow-up. |
| Classification of Deficient Samples | 11 out of 11 correctly classified as "Deficient" | Compared against predicate device results for 2 clinically-confirmed patients and 10 CDC deficient controls. |
| Classification of Partial Activity Samples | 4 out of 5* correctly classified as "Partial Activity" | Compared against predicate device. One partial* sample and 11 deficient samples represent the 2 clinically-confirmed patients and 10 CDC deficient controls. |
| Classification of Normal Samples | 559 out of 560 correctly classified as "Normal" | Compared against predicate device for 564 unclassified patient samples. One discrepant result (Normal by microplate kit, Partial Activity by predicate) was not confirmed by follow-up. One discrepant result (Normal by microplate kit, Deficient by predicate) was not confirmed by follow-up. |
| Within-Run Precision (Low Activity) | CV = 6.3% (Avg 18.3 MRU) | Predicate device CV = 17% (Avg 0.54 ERU). New device shows significant improvement. |
| Within-Run Precision (Moderate Activity) | CV = 4.4% (Avg 50.7 MRU) | Predicate device CV = 3.2% (Avg 14.6 ERU). |
| Within-Run Precision (Normal Activity) | CV = 3.8% (Avg 124.9 MRU) | Predicate device CV = 4.7% (Avg 79.6 ERU). New device shows improvement. |
| Total Precision (Low Activity) | CV = 9.4% (Avg 18.3 MRU) | Predicate device CV = 56% (Avg 0.54 ERU). New device shows significant improvement. |
| Total Precision (Moderate Activity) | CV = 7.3% (Avg 50.7 MRU) | Predicate device CV = 6.4% (Avg 14.6 ERU). |
| Total Precision (Normal Activity) | CV = 7.1% (Avg 124.9 MRU) | Predicate device CV = 5.8% (Avg 79.6 ERU). |
| Interference: Sulfamethoxazole | 1.58 mmol/L causes clinically significant effect. | Predicate: "No limit established, but a known interference is cited." Suggests patients treated with sulfonamides need alternate screening. |
| Interference: Albumin | Above normal concentrations can show 1.6 MRU positive interference per 1 g/dL. | Predicate: 25 g/L albumin no interference; > 25 g/L significant interference. |
| Interference: Hemoglobin | 2 g/L hemoglobin no clinically significant interference. | Predicate: 1 g/L hemoglobin no clinically significant interference. |
| Interference: Lipids | 37 mmol/L caused a decrease in response (may cause false positives). | Predicate: 2.5 g/L lipids no clinically significant interference. "No risk to deficient patients" noted for new device. |
| Interference: Bilirubin | 342 µmol/L (direct/indirect) no clinically significant interference. | Predicate: 0.25 g/L bilirubin no interference. |
| Interference: Trimethoprim | 138 µmol/L caused a decrease in response (may cause false positives). | Predicate: "No limit established." "No risk to deficient patients" noted for new device. |
| Interference: Gamma globulin | 60 g/L no clinically significant interference. | Predicate: "No limit established." |
Punctuation for specific values in the table above can be found in the excerpt itself.
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size:
- Classification Study: 564 unclassified patient samples, 2 biotinidase deficient patient samples, and 10 deficient controls. Total of 576 samples.
- Precision Study:
- Within-Run & Total Precision (main): n = 80 for each activity level (Low, Moderate, Normal) for the Microplate Kit. n = 32 (Low), n = 44 (Moderate), n = 44 (Normal) for the Predicate Device.
- Additional 5-day Low Activity Precision: n = 80 for the Microplate Kit.
- Data Provenance:
- Classification Study: The 2 deficient patient samples were "clinically-confirmed." The 10 deficient controls were "provided by the Centers for Disease Control (CDC)." The 564 unclassified patient samples are not explicitly stated in terms of specific country of origin, but generally, patient samples for such studies imply a clinical setting.
- Prospective/Retrospective: The text implies a retrospective analysis as samples "were treated according to the procedures detailed under SPEDMEN COLLECTION AND PREPARATION FOR ANALYSIS in the product insert," suggesting these were existing samples processed with the new kit.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- The document implies that the ground truth for the two "clinically-confirmed" deficient patient samples was established by clinical diagnosis, as they are referred to as "persons clinically-confirmed as such."
- For the 10 deficient controls, the ground truth was "provided by the Centers for Disease Control (CDC)," which suggests these are established and certified deficient samples.
- The "experts" themselves and their specific qualifications are not detailed in the provided text. The predicate device's classification served as a comparative ground truth for other samples and for discrepancies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- The document mentions "Discrepant results ** were not confirmed by follow-up testing." This indicates that for samples where the new Microplate Kit and the Predicate Device yielded different classifications (e.g., Microplate Kit: Normal, Predicate Device: Partial Activity), no explicit expert adjudication or further follow-up gold standard testing was performed to resolve the discrepancy for the purpose of this study report. The discrepancy is simply noted. Therefore, an explicit adjudication method (like 2+1 or 3+1) was not described or applied to resolve discrepancies for the reported results. The predicate device's classification was primarily used as a comparative benchmark, not an adjudicated ground truth in cases of disagreement.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This device is an in-vitro diagnostic (IVD) reagent kit that measures biotinidase activity, not an AI-powered diagnostic imaging tool or a system involving human readers interpreting outputs. It's a chemical assay. The comparison is between the new kit and a predicate kit (both laboratory assays), not between humans with and without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, the performance presented is standalone for the device (algorithm/assay only). The kit measures biotinidase activity using a spectrophotometer, which is an automated reading of a chemical reaction. The results described (linearity, sensitivity, precision, classification) are direct outputs of the assay kit itself without human interpretation influencing the measurable outcome, although trained laboratory personnel are required for manual steps (e.g., pipetting, filtration). The "human-in-the-loop" would be the technician performing the assay and reviewing the numerical results, but the performance metrics reported are for the assay's output itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Clinical Confirmation/Certified Controls and Predicate Device Comparison:
- For deficient patient samples, "clinical confirmation" of biotinidase deficiency was the ground truth.
- For deficient controls, the "Centers for Disease Control (CDC)" provided samples with established deficiency.
- For the bulk of the samples (564 unclassified), the predicate device's classification served as the comparative benchmark. While not a "true" independent ground truth for every sample, it's used as the standard against which the new device's classifications are measured for substantial equivalence.
8. The sample size for the training set:
- The document does not explicitly mention a separate "training set" in the context of machine learning or AI. As a reagent kit for a chemical assay, it does not typically involve explicit "training data" in the AI sense. The development of such kits often involves extensive R&D and optimization, but this is usually not referred to as a "training set" in the same way an AI model would have one.
9. How the ground truth for the training set was established:
- As a "training set" in the AI sense is not specified, the method for establishing its "ground truth" is also not applicable or described within the document. The development of the assay would rely on established biochemical principles and validation using known concentrations and clinical samples.
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I N T E R N A T I O N A L
NOV - 4 2008
Summary, 510(k) No. K080294
1. Name, Address of Contact Person and Date of Preparation
Applicants name and address
Astoria-Pacific, Inc. FDA Establishment No. 3050015 15130 SE 82nd Drive Post Office Box 830 Clackamas, OR 97015-0830
Tel 1-503-657-3010 Fax 1-503-655-7367
Charles A. Peterson CEO
Jason Reynolds Official Correspondent Director of Research & Development
Signature of Applicant:
Date: October 23, 2008
jason reynolds
Jason Reynolds
2. Name of the Device
Product Classification
Regulation Number 510(k) Number Classification Panel Product Code Device Classification
21 CFR 862.1118 K080294 Clinical Chemistry NAK Class II
Product Nomenclature
Common Name Classification Name Proprietary Name
Model Number
Biotinidase Screening Test Biotinidase Test System Astoria-Pacific SPOTCHECK® Biotinidase Microplate Reagent Kit Astoria-Pacific Part No. 81-8000-13K
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Summary, 510(k) No. K080294
3. Identification of the legally-marketed device for which substantial equivalence is claimed
Product Classification
| Regulation Number | 21 CFR 862.1118 |
|---|---|
| 510(k) Number | K010844 |
| Classification Panel | Clinical Chemistry |
| Product Code | NAK |
| Device Classification | Class II |
Product Nomenclature
| Common Name | Biotinidase Screening Test |
|---|---|
| Classification Name | Biotinidase Test System |
| Proprietary Name | Astoria-Pacific SPOTCHECK |
| Model Numbers | Biotinidase Kit, 50-HourAstoria-PacificPart Number 80-8000-13K |
4. Description of the Device
SPOTCHECK Biotinidase Microplate Reagent Kit
API Part No. 81-8000-13K Biotinidase Test System
KIT CONTENTS:
Color Reagent 1 Color Reagent I Diluent Color Reagent 2 Color Reagent 2 Diluent Color Reagent 3 Substrate Substrate Diluent Substrate Buffer Stock Standard Trichloroacetic acid (TCA)
Biotinidase activity is determined by measuring the color that develops from p-Aminobenzoic Acid (PABA) after PABA is released from Biotinyl-p-Aminobenzoate (Biotin-PAB). Samples with biotinidase activity develop a purple color. Samples without biotinidase activity remain straw-colored.
Patient samples of whole blood collected on standardized filter paper are eluted in a standard 96 well microplate. The plate is incubated with Biotin-PAB in a buffer at 37℃ for 240 minutes on a combination incubator/shaker. Following incubation, TCA is added to the sample mixture and the resulting precipitate is
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Biotinidase Reagent Kit
Image /page/2/Picture/2 description: The image shows the logo for Astoria-Pacific International. The text "Astoria-Pacific" is in a bold, stylized font, with a trademark symbol to the right of "Pacific". Below this, the word "INTERNATIONAL" is written in a smaller, sans-serif font. The logo is simple and professional, likely representing a company with a global reach.
Summarv, 510(k) No. K080294
removed through filtration. The PABA in the filtrate is subsequently diazotized and coupled to a napthol derivative to form an azo dye by the successive addition of sodium nitrite, acidic ammonium sulfamate and finally, N-1-naphthylethylenediamine dihydrochloride (NED). The azo dye is measured colorimetrically at 550 nm on a commercial microplate absorbance reader with a reference measurement at 690 mm.
Biotinidase Biotin-PAB ------------> Biotin + PABA
NO2, NH2SO2 PABA --------------> Purple chromophore NED
The color developed is proportional to the biotinidase activity in the sample. A standard curve prepared from a stock PABA solution is used to evaluate the results.
ર. Statement of Intended Use
This method is for the semi-quantitative determination of biotinidase, EC 3.5.1.12, activity in dried whole blood spots using a spectrophotometer. Measurement of biotinidase activity is primarily for the diagnosis and treatment of biotinidase deficiency in newborns. This method for in vitro diagnostic use to aid in screening for decreased levels of biotinidase activity and not for monitoring purposes.
This device is 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 Biotinidase Microplate Reagent Kit and the predicate device is the intended analyzer platform. The predicate device is used on a segmented-flow analyzer while the new reagent kit is for manual laboratory use only, applying simple bench chemistry techniques (e.g. pipetting) and utilizing a combination incubator/shaker and spectrophotometric microplate reader. The units used for the two assay kits are also different: microplate response units (MRU) for the new kit and enzyme response units (ERU) for the predicate device (1 MRU + 1 ERU).
Newborn patient blood spots are punched into microplate wells, eluted and incubated with the same substrate and buffer system as on the predicate device. Extraction and incubation occur concurrently, whereas on the predicate device, samples are first eluted, then vacuum filtered and subsequently incubated on the analyzer system. The predicate device utilizes automated dialysis to remove interferences. The SPOTCHECK Biotinidase Microplate Reagent Kit however, uses a reagent not included with the predicate device to precipitate matrix interferences which are subsequently removed through vacuum filtration. The same reagent formulation is used on both devices to generate the azo dye measured at 550 nm.
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I N T E R N A T I O N A L
Summary, 510(k) No. K080294
Summary of Predicate Device and Microplate Kit Technological Characteristics
| SPOTCHECK BiotinidaseMicroplate Reagent Kit | Predicate Device | |
|---|---|---|
| Sample collection andhandling | Use standardized filter paper,S&S®903TMFollow CLSI document LA4-A5: BloodCollection on Filter Paper for NewbornScreening | Same collection and handling |
| Sample | 2 x 1/8" punched blood spot | Same patient sampling |
| Incubation | In microplate, on combinationincubator/shaker | On flow analyzer system |
| Matrix interferencemitigation | Chemical precipitation andmanual vacuum filtration | Manual vacuum filtration anddialysis on the flow analyzersystem |
| Incubation Temp | 37°C | 40°C |
| Incubation Time | 240 minutes | ~120 minutes |
| Color Reagents | Sodium nitrite, acidicammonium sulfate, NED | Same formulation |
| Incubation substrate | Buffered Biotinyl-p-Aminobenzoate | Same formulation |
| Absorbancemeasurements | Spectrophotometric microplatereader -550 nm (reference at 690 nm) | Flow through split-beamspectrophotometer - 550 nm |
| Units of measurement | Microplate response unit(MRU)1 MRU equals 1 umol of p-aminobenzoic acid producedfrom Biotin-PAB per dL per240 minutes of incubation at37°C | Enzyme response unit (ERU)1 ERU defined as the azo dyeformed from 1 umol of p-aminobenzoic acid producedfrom Biotin-PAB per dL per~120 min. of incubation at40°C |
| Deficient cutoff | 10% mean activity of population | Same cutoff |
| Partial Activity cutoff -Clinical decision level | 37% mean activity of population | Same cutoff |
LINEARITY
Calibration standards are analyzed at the beginning of each assay using the SPOTCHECK Biotinidase Microplate Kit, as with the predicate device. The calibration utilizing PABA standards ranges from 0 to 200 MRU with a typical correlation coefficient of at least 0.999. Additionally, the assay was deemed linear after evaluation over the range of 5 to 213 MRU adhering to CLSI EP6-A: Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline.
SENSITIVITY
The Limit of Blank (LoB) and Limit of Detection (LoD) for biotinidase activity are 2 and 3 MRU, respectively, determined using the guidelines in the CLSI EP17-A protocol. The total error is less than the LoD, and the CLSI document prescribes that the Limit of Quantitation (LoQ) is equal to the LoD. This correlates well with the sensitivity of the predicate device.
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Summary, 510(k) No. K080294
DETERMINATION of CLINICAL CUTOFF
The recommendation for determining the clinical action cutoff for profound deficiency are the same for both devices: 37 and 10% of the mean patient result, respectively. As with the predicate device, each laboratory must determine its range of normal, partial and deficient levels of biotinidase activity, based on its population and analytical variables. All samples below the partial activity cutoff require follow-up screening according to local, state and federal laws.
CLASSIFICATION of DEFICIENT and UNCLASSIFIED PATIENT SAMPLES
The performance of the SPOTCHECK Biotinidase Microplate Reagent Kit was evaluated against the predicate device by analyzing unclassified (564) and biotinidase deficient (2) patient samples and (10) deficient controls provided by the Centers for Disease Control (CDC). All deficient patient samples are from persons clinically-confirmed as such. Samples analyzed with the SPOTCHECK Biotinidase Microplate Reagent Kit were treated according to the procedures detailed under SPECMEN COLLECTION AND PREPARATION FOR ANALYSIS in the product insert.
Classification of Samples during Device Comparison
| Predicate device | ||||
|---|---|---|---|---|
| Deficient | Partial Activity | Normal | ||
| Microplate Kit | Deficient | 11 of 11 | 0 | 0 |
| Partial Activity | 0 | 4 of 5* | 1** | |
| Normal | 0 | 1** | 559 of 560 |
Note: 1 partial* and the 11 deficient represent the 2 clinically-confirmed patients and 10 CDC deficient controls. Discrepant results ** were not confirmed by follow-up testing.
PRECISION
To evaluate within-run and total precision (according to CLSI Document EPS-A2) for the new device, Astoria-Pacific's Quality Assurance Laboratory completed 2 analyses per day, of samples in duplicate, for 20 days. An additional low-activity precision study was performed over 5-days only on the Microplate Kit. A summary of the data is shown below compared to the historical performance evaluation of the predicate device. The predicate device evaluation utilized data from 2 runs per day for 8 days (deficient) to 11 days (normal and near deficient) according to NCCLS Document EPS-T.
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Astoria-Pacific, Inc.
N T E R N A T I O N A L
Summary, 510(k) No. K080294
Within-Run Precision, SWR
SPOTCHECK Biotinidase Microplate Reagent Kit
| BiotinidaseActivity,MRU | LowActivityn = 80 | ModerateActivityn = 80 | Normaln = 80 |
|---|---|---|---|
| Average | 18.3 | 50.7 | 124.9 |
| S.D. | 1.2 | 2.2 | 4.7 |
| C.V. | 6.3% | 4.4% | 3.8% |
| Predicate Device | |||
|---|---|---|---|
| BiotinidaseActivity,ERU | LowActivityn = 32 | ModerateActivityn = 44 | Normaln = 44 |
| Average | 0.54 | 14.6 | 79.6 |
| S.D. | 0.09 | 0.47 | 3.8 |
| C.V. | 17% | 3.2% | 4.7% |
Total Precision, ST
SPOTCHECK Biotinidase Microplate Reagent Kit
| BiotinidaseActivity,MRU | LowActivityn = 80 | ModerateActivityn = 80 | Normaln = 80 |
|---|---|---|---|
| Average | 18.3 | 50.7 | 124.9 |
| S.D. | 1.7 | 3.7 | 8.9 |
| C.V. | 9.4% | 7.3% | 7.1% |
| BiotinidaseActivity,ERU | LowActivityn = 32 | ModerateActivityn = 44 | Normaln = 44 |
| Average | 0.54 | 14.6 | 79.6 |
| S.D. | 0.30 | 0.94 | 4.5 |
| C.V. | 56% | 6.4% | 5.8% |
Predicate Device
Additional 5-day study results
SPOTCHECK Biotinidase Microplate Reagent Kit
| Mean Biotinidase Activity,MRU (n = 80) | 10.3 |
|---|---|
| Sr (within-run precision) | 0.6 |
| C.V. (within-run) | 5.8% |
| B (daily mean precision) | 0.8 |
| ST (total precision) | 1.1 |
| C.V. (total) | 9.7% |
The SPOTCHECK Biotinidase Microplate Reagent Kit is effective at screening out patient samples deficient in biotinidase activity. The precision is comparable and in some cases, greatly improved.
INTERFERING SUBSTANCES
No known significant differences that would affect safety and effectiveness were observed when compared to the predicate device during the evaluation of interfering substances. The SPOTCHECK Biotinidase Microplate Reagent Kit was evaluated according to CLSI EP7-A2: Interference Testing in Clinical Chemistry, Approved Guideline. A summary of the findings and comparison to the predicate device is presented below.
| Interference Evaluated | SPOTCHECK Biotinidase MicroplateReagent Kit | Predicate Device |
|---|---|---|
| Sulfonamides1 | 1.58 mmol/L (400 $ $\mu$ $ g/mL)sulfamethoxazole has a clinicallysignificant effect on biotinidase activityclassification - patients treated withsulfonamides should be screened usingan alternate method | No limit established, but aknown interference is cited |
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Astoria-Pacific, Inc.
| Astoria-PacificTM | ||||||
|---|---|---|---|---|---|---|
| INTERNATIONAL |
| Albumin | albumin concentrations above normal canshow positive interference of 1.6 MRUper 1 g/dL albumin | 25 g/L albumin showed nointerference; > 25 g/L effectedsignificant interference |
|---|---|---|
| Hemoglobin | 2 g/L hemoglobin caused no clinicallysignificant interference | 1 g/L hemoglobin caused noclinically significantinterference |
| Lipids | 37 mmol/L (3270 mg/dL) lipids caused adecrease in response; may cause falsepositives - no risk to deficient patients | 2.5 g/L lipids showed noclinically significantinterference |
| Bilirubin | 342 µmol/L direct (conjugated) orindirect (unconjugated) bilirubin (~0.3and ~0.2 g/L, respectively) caused noclinically significant interference | 0.25 g/L bilirubin showed nointerference |
| Trimethoprim | 138 µmol/L (40 µg/mL) trimethoprimcaused a decrease in response; may causefalse positives - no risk to deficientpatients | No limit established |
| Gamma globulin | 60 g/L gamma globulin caused noclinically significant intereference | No limit established |
Phenytoin, ampicillin, gentamicyn sulfate, vitamin K, penicillin G potassium, kanamycin sulfate, adrenocorticotropic hornone, valproic acid and sodium phenobarbital do not interfere at therapeutic concentrations. 1.2
7. Determination of Substantial Equivalency
Based on performance characteristics and comparison data, we believe this device to be safe, effective, and substantially equivalent to the legally-marketed predicate device. The indications for use are for the SPOTCHECK Biotinidase Microplate Reagent Kit and the predicate device. Technological characteristics are very similar to the predicate device and there is sufficient evidence demonstrating that the differences do not significantly affect safety and effectiveness when analyzing clinical patients.
l. Gregory S. Heard, J. S. McVoy and B. Wolf, A Screening Method for Biotinidase Deficiency in Newborns, Clinical Chemistry, 30, 125-127, 1984.
- Barry Wolf, G. S. Heard, K. A. Weissbecker, J. R. Secor MeVoy, R. E. Gricr and R. T. Leshner, Biotinidase Deficiency: Initial Clinical Features and Rapid Diagnosis, Annals of Neurology, 18, 614-617, 1985.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Druq Administration 2098 Gaither Road Rockville MD 20850
Astoria-Pacific, Inc. c/o Mr. Jason Revnolds Official Correspondent 15130 SE 82nd Drive P.O. Box 830 Clackamas, Oregon 97015
NOV - 4 2008
Re: K080294
Trade/Device Name: Spotcheck Biotinidase Microplate Reagent Kit Regulation Number: 21 CFR 862.1118 Regulation Name: Biotinidase test system Regulatory Class: Class II Product Code: NAK Dated: October 23, 2008 Received: October 27, 2008
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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the r Division of Small Manufacturers, International and Consumer Assistance at its toll frea mober (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Jean M. Cooper, M.S., D.v.M.
Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) K080294
SPOTCHECK® Biotinidase Microplate Reagent Kit
INTENDED USE
This method is for the semi-quantitative determination of biotinidase, EC 3.5.1.12, activity in dried whole blood spots using a spectrophotometer. Measurement of biotinidase activity is primarily for the diagnosis and treatment of biotinidase deficiency in newborns. This method is intended for in vitro diagnostic use in screening for decreased levels of biotinidase activity and not for monitoring purposes.
This device is for use by trained, qualified clinical laboratory personnel.
Prescription Use X (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Carol C. Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K080294
Page 20 of 53
§ 862.1118 Biotinidase test system.
(a)
Identification. The biotinidase test system is an in vitro diagnostic device intended to measure the activity of the enzyme biotinidase in blood. Measurements of biotinidase are used in the treatment and diagnosis of biotinidase deficiency, an inborn error of metabolism in infants, characterized by the inability to utilize dietary protein bound vitamin or to recycle endogenous biotin. The deficiency may result in irreversible neurological impairment.(b)
Classification. Class II (special controls). The special control is sale, distribution, and use in accordance with the prescription device requirements in § 801.109 of this chapter.