(283 days)
The AutoDELFIA® Neonatal 17a-OH-progesterone kit is intended for the quantitative determination of human 17a-OH-progesterone in blood specimens dried on filter paper as an aid in screening newborns for congenital adrenal hyperplasia (CAH) using the 1235 AutoDELFIA® automatic immunoassay system.
The AutoDELFIA Neonatal 17α-OH-progesterone (17-OHP) assay is a solid phase, time-resolved fluoroimmunoassay based on the competitive reaction between europium-labeled 17-OHP and sample 17-OHP for a limited amount of binding sites on 17-OHP specific polyclonal antibodies (derived from rabbit). Danazol facilitates the release of 17-OHP from the binding proteins. A second antibody, directed against rabbit IgG, is coated to the solid phase, giving convenient separation of the antibody-bound and free antigen. Enhancement Solution dissociates europium ions from the labeled antigen into solution where they form highly fluorescent chelates with components of the Enhancement Solution. The fluorescence in each well is then measured. The fluorescence of each sample is inversely proportional to the concentration of 17-OHP in the sample.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: AutoDELFIA® Neonatal 17α-OH-progesterone kit (B024)
Intended Use: Quantitative determination of human 17α-OH-progesterone in blood specimens dried on filter paper as an aid in screening newborns for congenital adrenal hyperplasia (CAH) using the 1235 AutoDELFIA® automatic immunoassay system.
1. Table of Acceptance Criteria and Reported Device Performance
The document describes the proposed device (B024) as substantially equivalent to a predicate device (K042425, B015) and highlights differences in performance characteristics. The acceptance criteria are implicitly defined by demonstrating similar or improved performance compared to the predicate device, especially regarding cross-reactivity and screening efficacy.
| Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Proposed Device (B024) Performance |
|---|---|---|
| Antibody Cross-Reactions | Lower cross-reactivity with physiologically important steroids in neonates than predicate device. | 17α-OH pregnenolone sulfate: 0.78 % (Predicate: 2.0 %) 11-Deoxycortisol: 0.62 % (Predicate: 1.82 %) 17α-OH pregnenolone: 0.83 % (Predicate: 1.20 %) Progesterone: 0.37 % (Predicate: 0.47 %) |
| Analytical Sensitivity / Limit of Blank (LoB) | 1.3 ng/mL serum (Predicate) | 0.37 ng/mL serum (Improved) |
| Analytical Sensitivity / Limit of Detection (LoD) | Not explicitly stated for predicate in table, but overall analytical sensitivity is desired to be good. | 0.84 ng/mL serum (Improved over predicate's LoB) |
| Analytical Sensitivity / Limit of Quantitation (LoQ) | Not explicitly stated for predicate in table. | 1.4 ng/mL serum |
| Precision (Total Variation, full calibration curve) | CV% values for various concentrations (e.g., 13.2% for 25.9 ng/mL, 10.8% for 53.0 ng/mL, 10.9% for 114 ng/mL) | Range of CV% values (e.g., 13.0% for 2.12 ng/mL, 9.8% for 4.69 ng/mL, 14.8% for 7.52 ng/mL, 8.3% for 27.0 ng/mL, 9.2% for 54.4 ng/mL, 10.8% for 109 ng/mL, 9.1% for 182 ng/mL) |
| Precision (Total Variation, one calibration curve per 4 plates) | CV% values for various concentrations (e.g., 14.0% for 25.8 ng/mL, 12.4% for 52.9 ng/mL, 11.8% for 115 ng/mL) | Range of CV% values (e.g., 14.0% for 2.25 ng/mL, 12.0% for 4.89 ng/mL, 15.8% for 7.79 ng/mL, 9.7% for 27.7 ng/mL, 10.5% for 55.7 ng/mL, 12.7% for 113 ng/mL, 11.3% for 188 ng/mL) |
| Screening Efficacy (CAH case detection) | Must detect known CAH cases similarly or better than predicate device. | Detected all known CAH cases in studies at appropriate cut-off with one exception for very high percentiles. For instance, in Study 1, ≥ 2250 g, 90th percentile, 13 out of 13 CAH cases were detected. In Study 2, ≥ 2250 g, 90th percentile, 13 out of 13 CAH cases were detected. (See * below for exception) |
| Median Values in Newborn Screening | Comparable patterns to predicate, potentially with lower absolute values due to reduced cross-reactivity. | For Studies 1 & 2, median values for various weight categories were consistently lower for B024 compared to B015, supporting the claim of reduced cross-reactivity and increased specificity. |
In Study 1, < 1250 g, 95th percentile, the new kit detected 1 out of 2 CAH cases (the other case was due to maternal CAH treatment impacting the results). In Study 2, ≥ 2250 g, 95th percentile, using percentiles higher than the 90th resulted in one false negative out of 13 clinically confirmed CAH samples. The document notes that laboratories should consider this when setting screening cut-offs.
The Study Proving Device Meets Acceptance Criteria
The device's performance was evaluated through screening efficacy studies performed in two newborn screening laboratories, comparing the proposed kit (B024) to the predicate device (B015).
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Sizes:
- Study 1:
- < 1250 g: 364 subjects (Tables 2 & 3)
- 1250-2249 g: 500 subjects (Tables 4 & 5)
- ≥ 2250 g: 1328 subjects (Tables 6 & 7)
- Total Study 1: 2192 subjects
- Study 2:
- < 1250 g: 168 subjects (Tables 8 & 9)
- 1250-2249 g: 372 subjects (Tables 10 & 11)
- ≥ 2250 g: 1299 subjects (Tables 12 & 13)
- Total Study 2: 1839 subjects
- Total Samples for Screening Efficacy: 2192 + 1839 = 4031 subjects (pooled studies, across different weight categories and percentiles).
- Known CAH Cases:
- Study 1: 17 confirmed CAH cases.
- Study 2: 13 confirmed CAH cases (all in ≥ 2250g category).
- Study 1:
- Data Provenance: Retrospective specimens and excess samples. The country of origin is not explicitly stated, but the submitter is Wallac Oy, Finland, suggesting the studies likely occurred in European or Western laboratories.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document refers to "confirmed CAH case samples" and "clinically confirmed CAH samples." It does not specify the number of experts or their qualifications directly involved in establishing the ground truth for the individual test samples. The implication is that the CAH diagnoses were established clinically prior to the samples being used for the study.
4. Adjudication Method for the Test Set
The document does not describe an explicit adjudication method (e.g., 2+1, 3+1) for the ground truth of the test set samples. It relies on previously "confirmed" or "clinically confirmed" CAH diagnoses.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This device is an in-vitro diagnostic (IVD) kit that provides quantitative measurements, not an imaging AI algorithm requiring human reader interpretation with or without AI assistance. The comparison is between the performance of two IVD kits.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, this was a standalone performance study. The device (immunoassay kit) directly produces a quantitative result (17-OHP concentration), which is then compared against established cut-offs. There is no "human-in-the-loop" component in the interpretation of the kit's raw result in the context of this performance assessment, although human laboratory personnel perform the assay and clinical interpretation of results based on screening guidelines.
7. The Type of Ground Truth Used
The ground truth used was clinical diagnosis/outcomes data for Congenital Adrenal Hyperplasia (CAH). The document refers to "confirmed CAH case samples" and "clinically confirmed CAH samples."
8. The Sample Size for the Training Set
The document does not provide details of a specific "training set" in the context of machine learning. For an IVD kit like this, "training" typically refers to the assay development and validation process (e.g., antibody selection, calibration curve establishment, optimization of reagents), which is not quantified by a sample size in the same way as an AI algorithm's training data. The description indicates a "new antiserum in B024," which suggests a re-optimization or re-development that would have involved internal validation and method development.
9. How the Ground Truth for the Training Set was Established
As noted above, a distinct "training set" with ground truth in the AI/ML sense is not applicable here. The ground truth for developing and validating the assay's components (like the new antiserum) would have involved:
- Characterization of pure steroid compounds for cross-reactivity assessment.
- Use of spiked samples with known concentrations of 17-OHP to establish linearity, analytical sensitivity, and precision.
- Reference methods or established clinical samples during assay development and optimization to ensure it accurately measures 17-OHP.
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APK 1 6 2009
.
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.
The Assigned 510(k) Number is: _______________________________________________________________________________________________________________________________________________
| Submitter: | Wallac OyMustionkatu 620750 Turku, Finland |
|---|---|
| Telephone: | +358 2 2678111 |
| Fax: | +358 2 2678357 |
| Contact Person: | Katriina SuonpääRegulatory Affairs Managerkatriina.suonpaa@perkinelmer.com |
| Date of Summary Prepared: | April 07, 2009 |
| Device Name: | AutoDELFIA® Neonatal 17α-OH-progesterone kit |
| Classification Name: | Radioimmunoassay, 17-HydroxyprogesteroneClass I per 21 CFR § 862.1395 |
| Product Code: | JLX |
| Predicate Device: | AutoDELFIA® Neonatal 17α-OH-progesterone kit,510(k) Number K042425 |
| Device Description: | The AutoDELFIA Neonatal 17α-OH-progesterone(17-OHP) assay is a solid phase, time-resolvedfluoroimmunoassay based on the competitive reactionbetween europium-labeled 17-OHP and sample 17-OHPfor a limited amount of binding sites on 17-OHP specificpolyclonal antibodies (derived from rabbit). Danazolfacilitates the release of 17-OHP from the bindingproteins. A second antibody, directed against rabbit IgG,is coated to the solid phase, giving convenient separationof the antibody-bound and free antigen. |
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Enhancement Solution dissociates europium ions from the labeled antigen into solution where they form highly fluorescent chelates with components of the Enhancement Solution. The fluorescence in each well is then measured. The fluorescence of each sample is inversely proportional to the concentration of 17-OHP in the sample.
Intended Use: The AutoDELFIA Neonatal 17a-OH-progesterone kit is intended for the quantitative determination of human 17a-OH-progesterone in blood specimens dried on filter paper as an aid in screening newborns for congenital adrenal hyperplasia (CAH) using the 1235 AutoDELFIA® automatic immunoassay system.
The AutoDELFIA Neonatal 17α-OH-progesterone kit Substantial Equivalence: (B024) is substantially equivalent to our currently marketed AutoDELFIA Neonatal 17x-OH-progesterone kit (B015) (K042425). The primary difference is a new antiserum in B024. The new antiserum has less crossreactivity with the physiologically important steroids in neonates, making it more specific for measuring 17a-OHprogesterone. There are the following similarities and differences between the two kits:
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·
Table 1. Characteristics of the two kits.
| Characteristic | Proposed Device | Predicate Device |
|---|---|---|
| AutoDELFIA Neonatal17α-OH-progesterone kitB024 | AutoDELFIA Neonatal17α-OH-progesterone kitB015 | |
| Similarities | ||
| Intended User | Adequately trained laboratory personnel in laboratories performing newborn screening | Adequately trained laboratory personnel in laboratories performing newborn screening |
| Intended Use | Quantitative determination of 17α-OH-progesterone in blood specimens dried on filter paper | Quantitative determination of 17α-OH-progesterone in blood specimens dried on filter paper |
| Indication for Use | An aid in screening newborns for congenital adrenal hyperplasia | An aid in screening newborns for congenital adrenal hyperplasia |
| Chemical Principle | Competitive reaction between europium labeled 17-OHP and sample 17-OHP for a limited number of binding sites on 17-OHP specific polyclonal antibodies derived from rabbit | Competitive reaction between europium labeled 17-OHP and sample 17-OHP for a limited number of binding sites on 17-OHP specific polyclonal antibodies derived from rabbit |
| Assay Principle | Time-resolved fluoroimmunoassay | Time-resolved fluoroimmunoassay |
| Instrument | 1235 AutoDELFIA automatic immunoassay system | 1235 AutoDELFIA automatic immunoassay system |
| Detection principle | Time-resolved fluorescence | Time-resolved fluorescence |
| Specimen | Filter paper disks with a diameter of approximately 3.2 mm (1/8 inch) | Filter paper disks with a diameter of approximately 3.2 mm (1/8 inch) |
| Calibrator andControl Matrix | Human blood with a hematocrit of 50-55% and spotted onto filter paper cassettes (Whatman Grade 903) | Human blood with a hematocrit of 50-55% and spotted onto filter paper cassettes (Whatman Grade 903) |
| Calibration | Calibrated using gravimetric methods | Calibrated using gravimetric methods |
| Controls | 3 levels (approx. values 17, 45 and 100 ng/mL serum) | 3 levels (approx. values 17, 45 and 100 ng/mL serum) |
| Assay Buffer | 17-OHP Assay Buffer, ready for use | 17-OHP Assay Buffer, ready for use |
| Coated Plates | Anti-rabbit IgG Microtitration Strips,8 x 12 wells coated with anti-rabbitIgG (raised in goat) | Anti-rabbit IgG Microtitration Strips,8 x 12 wells coated with anti-rabbitIgG (raised in goat) |
| Characteristic,continued | Proposed DeviceAutoDELFIA Neonatal17α-OH-progesterone kitB024 | Predicate DeviceAutoDELFIA Neonatal17α-OH-progesterone kitB015 |
| Differences | ||
| Antibodies | Rabbit polyclonal antibodies | Different rabbit polyclonal antibodies |
| AntibodyCross-Reactionsin the Assay | 17α-OH pregnenolone sulfate 0.78 %11-Deoxycortisol 0.62 %17α-OH pregnenolone 0.83 %Progesterone 0.37 % | 17α-OH pregnenolone sulfate 2.0 %11-Deoxycortisol 1.82 %17α-OH pregnenolone 1.20 %Progesterone 0.47 % |
| Tracer | 17-OHP-Eu tracer stock solution, approximate concentration of 40 nmol/L, lyophilized | 17-OHP-Eu tracer stock solution, approximate concentration of 250 nmol/L, lyophilized |
| Calibrators | 6 levels(approx. values 0, 4, 10, 25, 75, and 220 ng/mL serum) | 6 levels(approx. values 0, 10, 25, 50, 100 and 250 ng/mL serum) |
| Analytical Sensitivity /Limit of Blank,Limit of Detection,Limit of Quantitation | Limit of Blank0.37 ng/mL serumLimit of Detection0.84 ng/mL serumLimit of Quantitation1.4 ng/mL serum | Analytical Sensitivity(Limit of Blank) 1.3 ng/mL serum |
| Precision (TotalVariation using a fullcalibration curve oneach plate) | 2.12 ng/mL serum CV% 13.04.69 ng/mL serum CV% 9.87.52 ng/mL serum CV% 14.827.0 ng/mL serum CV% 8.354.4 ng/mL serum CV% 9.2109 ng/mL serum CV% 10.8182 ng/mL serum CV% 9.1 | 25.9 ng/mL serum CV% 13.253.0 ng/mL serum CV% 10.8114 ng/mL serum CV% 10.9 |
| Precision (TotalVariation using onecalibration curve forevery batch of 4 plates) | 2.25 ng/mL serum CV% 14.04.89 ng/mL serum CV% 12.07.79 ng/mL serum CV% 15.827.7 ng/mL serum CV% 9.755.7 ng/mL serum CV% 10.5113 ng/mL serum CV% 12.7188 ng/mL serum CV% 11.3 | 25.8 ng/mL serum CV% 14.052.9 ng/mL serum CV% 12.4115 ng/mL serum CV% 11.8 |
| Median Values inNewborn Screening(Study 1) | < 1250 g 20.9 ng/mL serum1250-2249 g 9.7 ng/mL serum> 2250 g 6.7 ng/mL serum | < 1250 g 35.6 ng/mL serum1250-2249 g 20.0 ng/mL serum> 2250 g 14.1 ng/mL serum |
| Median Values inNewborn Screening(Study 2) | < 1250 g 13.3 ng/mL serum1250-2249 g 12.1 ng/mL serum> 2250 g 7.1 ng/mL serum | < 1250 g 30.2 ng/mL serum1250-2249 g 23.4 ng/mL serum>2250 g 13.7 ng/mL serum |
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Screening Efficacy:
The proposed kit and the predicate device were compared in two newborn screening laboratories using retrospective specimens and excess samples. A number of known CAH cases were included. The results categorizing the number of evaluation samples according to screening outcome are shown in Tables 2-7 (Study 1) and in Tables 8-13 (Study 2).
Study 1, Tables 2 - 7:
In total, 17 confirmed CAH case samples were available for the study. All of them were retrospective samples.
Table 2. Screening results and true diagnosis in the < 1250 g weight category, 90th percentile.
| New kit B024 | Old kit B015 | Total | Diagnosed | No diagnosed |
|---|---|---|---|---|
| Cut-off | Cut-off | Subjects | САН | САН |
| 56.7 ng/mL | 135 ng/mL | |||
| -- | + | 31 | 30 | |
| -- | 0 | |||
| + | 0 | |||
| 319 | * | 318 | ||
| Total | 364 | 2 | 362 |
Table 3. Screening results and true diagnosis in the < 1250 g weight category, 95th percentile.
| New kit B024 | Old kit B015 | Total | Diagnosed | No diagnosed |
|---|---|---|---|---|
| Cut-off | Cut-off | Subjects | САН | САН |
| 73.6 ng/mL | 178 ng/mL | |||
| 1 | + | 13 | 12 | |
| 0 | ||||
| + | 0 | |||
| 337 | 1* | 336 | ||
| Total | 364 | 2 | 362 |
- In this case, the mother had CAH. Treatment for CAH includes lifetime daily medication, prednisone or dexamethasone. Because the specimen was taken during the first day of life, the mother's treatment would have impacted the 17-OHP test result of the infant.
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Table 4. Screening results and true diagnosis in the 1250-2249g weight category, 90th percentile.
| New kit B024Cut-off33.5 ng/mL | Old kit B015Cut-off76.9 ng/mL | TotalSubjects | DiagnosedCAH | No diagnosedCAH |
|---|---|---|---|---|
| + | + | 38 | 1 | 37 |
| + | - | 16 | 1 | 15 |
| - | + | 13 | 0 | 13 |
| - | - | 433 | 0 | 433 |
| Total | 500 | 2 | 498 |
Table 5. Screening results and true diagnosis in the 1250 - 2249g weight category, 95th percentile.
| New kit B024Cut-off40.8 ng/mL | Old kit B015Cut-off98.4 ng/mL | TotalSubjects | DiagnosedCAH | No diagnosedCAH |
|---|---|---|---|---|
| + | + | 17 | 0 | 17 |
| + | - | 10 | 2 | 8 |
| - | + | 8 | 0 | 8 |
| - | - | 465 | 0 | 465 |
| Total | 500 | 2 | 498 |
Table 6. Screening results and true diagnosis in the ≥ 2250 g weight category, 90th percentile.
| New kit B024Cut-off14.3 ng/mL | Old kit B015Cut-off31.5 ng/mL | TotalSubjects | DiagnosedCAH | No diagnosedCAH |
|---|---|---|---|---|
| + | + | 119 | 13 | 106 |
| + | - | 28 | 0 | 28 |
| - | + | 26 | 0 | 26 |
| - | - | 1155 | 0 | 1155 |
| Total | 1328 | 13 | 1315 |
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Table 7. Screening results and true diagnosis in the ≥ 2250 g weight category, 95th percentile.
| New kit B024 | Old kit B015 | Total | Diagnosed | No diagnosed |
|---|---|---|---|---|
| Cut-off | Cut-off | subjects | САН | CAH |
| 20.9 ng/mL | 49.0 ng/mL | |||
| + | + | 60 | 11 | 49 |
| + | 19 | 2 | 17 | |
| + | 18 | 0 | 18 | |
| 1231 | 0 | 1231 | ||
| Total | 1328 | 13 | 1315 |
Study 2, Tables 8 - 13:
Confirmed CAH case samples were available only in the ≥ 2250g birth weight category, in total 13 cases. All of them were retrospective samples.
Table 8. Screening results and true diagnosis in the < 1250 g weight category, 90" percentile.
| New kit B024Cut-off59.5 ng/mL | Old kit B015Cut-off125 ng/mL | TotalSubjects | DiagnosedCAH | No diagnosedCAH |
|---|---|---|---|---|
| + | + | 15 | 0 | 15 |
| + | - | 2 | 0 | 2 |
| - | + | 2 | 0 | 2 |
| - | - | 149 | 0 | 149 |
| Total | 168 | 0 | 168 |
Table 9. Screening results and true diagnosis in the < 1250 g weight category, 95" percentile.
| New kit B024 | Old kit B015 | Total | Diagnosed | No diagnosed |
|---|---|---|---|---|
| Cut-off | Cut-off | Subjects | САН | САН |
| 95.0 ng/mL | 202 ng/mL | |||
| + | + | 0 | ||
| + | ব | 0 | ব | |
| + | 0 | |||
| ા રેરે | 0 | ા રે રે | ||
| Total | 1 68 | 0 | 168 |
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Table 10. Screening results and true diagnosis in the 1250 - 2249g weight category, 90th percentile.
| New kit B024Cut-off54.3 ng/mL | Old kit B015Cut-off137 ng/mL | TotalSubjects | DiagnosedCAH | No diagnosedCAH |
|---|---|---|---|---|
| + | + | 30 | 0 | 30 |
| + | - | 8 | 0 | 8 |
| - | + | 8 | 0 | 8 |
| - | - | 326 | 0 | 326 |
| Total | 372 | 0 | 372 |
Table 11. Screening results and true diagnosis in the 1250 - 2249g weight category, 95th percentile.
| New kit B024Cut-off68.6 ng/mL | Old kit B015Cut-off167 ng/mL | TotalSubjects | DiagnosedCAH | No diagnosedCAH |
|---|---|---|---|---|
| + | + | 11 | 0 | 11 |
| + | - | 8 | 0 | 8 |
| - | + | 8 | 0 | 8 |
| - | - | 345 | 0 | 345 |
| Total | 372 | 0 | 372 |
Table 12. Screening results and true diagnosis in the ≥ 2250 g weight category, 90" percentile.
| New kit B024 | Old kit B015 | Total | Diagnosed | No diagnosed |
|---|---|---|---|---|
| Cut-off | Cut-off | Subjects | САН | САН |
| 16.1 ng/mL | 32.9 ng/mL | |||
| + | + | 121 | 13 | 108 |
| + | 21 | 0 | 21 | |
| -- | 21 | 0 | 21 | |
| 1136 | 0 | 1136 | ||
| Total | 1 299 | 13 | 1286 |
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Table 13. Screening results and true diagnosis in the ≥ 2250 g weight category, 95th percentile.
| New kit B024Cut-off28.3 ng/mL | Old kit B015Cut-off66.5 ng/mL | TotalSubjects | DiagnosedCAH | No diagnosedCAH |
|---|---|---|---|---|
| + | + | 68 | 12 | 56 |
| + | - | 9 | 0 | 9 |
| - | + | 10 | 0 | 10 |
| - | - | 1212 | 1* | 1211 |
| Total | 1299 | 13 | 1286 |
- Using percentiles higher than the 90" percentile as the assay's cut-off resulted in one
false negative result out of the 13 clinically confirmed CAH samples assayed Laboratories should take this into consideration when setting their screening cut-offs.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Wallac Oy c/o Katriina Suonpää Regulatory Affairs Manager Mustionkatu 6 20750 Turku, Finland
APR 1 6 2009
Re: K081922
Trade/Device Name: AutoDELFIA Neonatal 17α-ΟΗ-progesterone kit Regulation Number: 21 CFR 862.1395 Regulation Name: Radioimmunoassay, 17-Hydroxyprogesterone Regulatory Class: Class I, meets limitations of exemptions under 21 CFR § 862.9 (c)(2) Product Code: JLX Dated: March 27, 2009 Received: April 2, 2009
Dear Katriina Suonpää:
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 (301) 594-3084. 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Cory C. He
Courtney C. Harper, Ph.D. Acting 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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Indication for Use
08/922
510(k) Number (if known):
Device Name:
Indication For Use:
AutoDELFIA® Neonatal 17a-OH-progesterone kit
The AutoDELFIA® Neonatal 17a-OH-progesterone kit is intended for the quantitative determination of human 170-OH-progesterone in blood specimens dried on filter paper as an aid in screening newborns for congenital adrenal hyperplasia (CAH) using the 1235 AutoDELFIA® automatic immunoassay system.
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 Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K081922
Page 1 of 1
§ 862.1395 17-Hydroxyprogesterone test system.
(a)
Identification. A 17-hydroxyprogesterone test system is a device intended to measure 17-hydroxyprogesterone (a steroid) in plasma and serum. Measurements of 17-hydroxyprogesterone are used in the diagnosis and treatment of various disorders of the adrenal glands or the ovaries.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.