(135 days)
The GSP Neonatal 17α-OH-progesterone kit is intended for the 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 GSP™ instrument.
The GSP Neonatal 17x-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. DELFIA Inducer dissociates europium ions from the labeled antigen into solution where they form highly fluorescent chelates with components of DELFIA Inducer. 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.
The provided text describes the GSP Neonatal 17α-OH-progesterone kit and its comparison to a predicate device, the AutoDELFIA Neonatal 17α-OH-progesterone kit. The primary study presented focuses on the "Screening Efficacy" of the new GSP kit by comparing its results to those of the predicate device using various percentile cut-offs.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" in a quantitative manner (e.g., "The device must achieve X% accuracy"). Instead, it demonstrates performance by comparing the new device (GSP kit) to the legally marketed predicate device (AutoDELFIA kit) and showing high agreement.
The screening efficacy tables (Tables 1-9) implicitly demonstrate the device's acceptable performance based on its agreement with the predicate device. For the purpose of this analysis, we will consider the "Overall percent agreement" with the predicate device as the key performance metric presented.
| Characteristic | Acceptance Criteria (Implicit, based on predicate comparison) | Reported Device Performance (GSP Neonatal 17α-OH-progesterone kit) |
|---|---|---|
| Screening Efficacy (Overall Percent Agreement with Predicate Device, AutoDELFIA kit) | ||
| - 90% cutoff, ≥2500g | High agreement with predicate device | 95.9% (CI 94.9%-96.8%) |
| - 90% cutoff, 1250g-2249g | High agreement with predicate device | 98.6% (CI 97.0%-99.5%) |
| - 90% cutoff, <1250g | High agreement with predicate device | 96.1% (CI 93.3%-98.0%) |
| - 95% cutoff, ≥2500g | High agreement with predicate device | 98.2% (CI 97.4%-98.7%) |
| - 95% cutoff, 1250g-2249g | High agreement with predicate device | 98.6% (Cl 97.0%-99.5%) |
| - 95% cutoff, <1250g | High agreement with predicate device | 96.8% (CI 94.1%-98.4%) |
| - 99% cutoff, ≥2500g | High agreement with predicate device | 99.8% (CI 99.5%-100%) |
| - 99% cutoff, 1250g-2249g | High agreement with predicate device | 98.2% (CI 96.4%-99.2%) |
| - 99% cutoff, <1250g | High agreement with predicate device | 100% (CI 98.8%-100%) |
| Method Comparison (Regression with Predicate Device) | Y = mx + c, with high R-value | Y= 0.97x + 0.27; r = 0.96 (for 2567 samples) |
| Analytical Sensitivity (Limit of Detection) | Comparable to predicate device | 1.4 ng/mL serum |
| Analytical Specificity (Cross-Reactions) | Comparable to predicate device | Similar percentages for various interfering substances |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: A total of 2589 specimens were evaluated across all weight categories and cut-offs.
- ≥2500g: 1842 specimens (Tables 1, 4, 7)
- 1250g-2249g: 439 specimens (Tables 2, 5, 8)
- <1250g: 308 specimens (Tables 3, 6, 9)
- Additionally, 23 known CAH cases were included within these 2589 samples.
- For the general method comparison (Y= 0.97x + 0.27; r = 0.96), 2567 samples were compared.
- Data Provenance: The study used retrospective archived specimens and leftover samples from specimens submitted for routine screening. The document does not specify the country of origin of the data, but it states the study was conducted "in one newborn screening laboratory."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention the use of experts to establish ground truth for this comparison study. Instead, the "ground truth" for the screening efficacy study is implicitly defined by the results of the predicate device (AutoDELFIA Neonatal 17α-OH-progesterone kit). The 23 "known CAH cases" would have had their diagnosis established through other means, likely clinical follow-up and definitive diagnostic tests, which are not detailed in this report.
4. Adjudication method for the test set
There is no mention of an adjudication method in the context of comparing the GSP kit to the AutoDELFIA kit. The comparison directly uses the test results from both devices.
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
This is not applicable. The device described is a quantitative in vitro diagnostic (IVD) kit for measuring 17α-OH-progesterone, not an AI-assisted diagnostic tool that involves human readers interpreting images or results. Therefore, no MRMC study or AI assistance effect size is discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the performance presented for the GSP Neonatal 17α-OH-progesterone kit is a standalone (algorithm only) performance. The kit is designed to quantitatively determine 17α-OH-progesterone levels in blood specimens using the GSP™ instrument; it does not involve human interpretation in the workflow described for the direct comparison.
7. The type of ground truth used
The primary "ground truth" against which the new device's performance is measured is the predicate device's performance (AutoDELFIA Neonatal 17α-OH-progesterone kit). This is a common approach for demonstrating substantial equivalence for new IVD devices.
Additionally, the study included 23 known CAH cases, indicating that these cases had a definitive diagnosis of Congenital Adrenal Hyperplasia, likely established through a combination of clinical outcomes, follow-up testing, and potentially genetic analysis, although the specific details are not provided. These cases served as a validation point within the overall sample set.
8. The sample size for the training set
The document describes a device comparison and does not explicitly reference a "training set" in the context of machine learning or algorithm development. This is an IVD kit, where performance is typically established through analytical and clinical validation studies rather than machine learning training.
9. How the ground truth for the training set was established
As there is no mention of a separate "training set" for an algorithm in this context, information on how its ground truth was established is not provided. The calibrators and controls used for the kit itself would be part of the manufacturing quality control and calibration process, established using gravimetric methods and human blood matrix (as mentioned in Table 1).
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510(k) SUMMARY
JUL 2 3 2010
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: K100682
Date: July 13, 2010 Wallac Oy, subsidiary of PerkinElmer Submitted by: Mustionkatu 6 20750 Turku, Finland Contact Person: Primary: Kay A. Taylor Tel: 317-418-1735 Fax: 317-536-3064 Katriina Suonpää Secondary: Tel: 011 358 2267 8111 Fax: 011 358 2267 8357 GSP® Neonatal 17a-OH-progesterone kit (3305-001U) Trade Name: Common Name: GSP Neonatal 17-OHP kit Regulation: 21 CFR 862.1395 Radioimmunoassay, 17-Hydroxyprogesterone Classification Name: Product Code: JLX Predicate Device: AutoDELFIA® Neonatal 17a-OH-progesterone kit, 510(k) Number (K081922) Device Description: The GSP Neonatal 17x-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. DELFIA Inducer dissociates europium ions from the
labeled antigen into solution where they form highly fluorescent chelates with components of DELFIA Inducer. The fluorescence in each well is then measured. The
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fluorescence of each sample is inversely proportional to the concentration of 17-OHP in the sample.
Intended Use:
The GSP Neonatal 17α-OH-progesterone kit is intended for the quantitative determination of human 17α-OHprogesterone in blood specimens dried on filter paper as an aid in screening newborns for congenital adrenal hyperplasia (CAH) using the GSP™ instrument.
Substantial Equivalence:
GSP Neonatal 17α-OH-progesterone kit is The substantially equivalent to our currently marketed AutoDELFIA Neonatal kit (K081922). There are the following similarities and differences between the two kits:
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Table 1. Characteristics of the two kits.
| Characteristic | GSP Neonatal 17αOHP kit(New Device) | AutoDELFIA Neonatal 17αOHP(Predicate Device) |
|---|---|---|
| Similarities | ||
| Intended User | Adequately trained laboratorypersonnel in laboratories performingnewborn screening | Same |
| Intended Use /Indications for Use | The GSP Neonatal 17α-OH-progesterone kit is intended for thequantitative determination ofhuman 17α-OH-progesterone inblood specimens dried on filterpaper as an aid in screeningnewborns for congenital adrenalhyperplasia (CAH) using theGSPTM instrument. | The AutoDELFIA Neonatal 17α-OH-progesterone kit is intendedfor the quantitativedetermination of human 17α-OH-progesterone in bloodspecimens dried on filter paperas an aid in screening newbornsfor congenital adrenalhyperplasia (CAH) using the1235 AutoDELFIA automaticimmunoassay system. |
| Chemical Principle | Competitive reaction betweeneuropium labeled 17-OHP and sample17-OHP for a limited number ofbinding sites on 17-OHP specificpolyclonal antibodies derived fromrabbit | Same |
| Detection principle | Time-resolved fluorescence | Same |
| Specimen | Filter paper disks with a diameter ofapproximately 3.2 mm (1/8 inch) | Same |
| Antibodies | Rabbit polyclonal antibodies | Same |
| Calibrator andControl Matrix | Human blood with a hematocrit of50-55% and spotted onto filter papercassettes (Whatman, no. 903) | Same |
| Calibration | Calibrated using gravimetric methods | Same |
| Controls | 3 levels (approx. values 17, 45 and100 ng/mL serum) | Same |
| Assay Buffer | 17-OHP Assay Buffer, ready for use | Same |
| Coated Plates | Anti-rabbit IgG Microtitration Strips,8 x 12 wells coated with anti-rabbitIgG (raised in goat) | Same |
| Calibrators | 6 levels(approx. values 0, 4, 10, 25, 75 and220 ng/mL serum) | Same |
| Characteristic,continued | GSP Neonatal 170HP kit(New Device) | AutoDELFIA Neonatal 170HP(Predicate Device) |
| Differences | ||
| Instrument | GSP Instrument | 1235 AutoDELFIA Instrument |
| Dissociationsolution | DELFIA Inducer | Enhancement Solution |
| AntibodyCross-Reactionsin the Assay | 17α-OH pregnenolone sulfate0.77 %11-Deoxycortisol 0.49 %17α-OH pregnenolone 0.80 %Progesterone 0.20 %21-Deoxycortisol 0.84%Deoxycorticosterone 0.01% | 17α-OH pregnenolone sulfate0.78 %11-Deoxycortisol 0.62 %17a-OH pregnenolone 0.83 %Progesterone 0.37 %21-Deoxycortisol 0.91%Deoxycorticosterone 0.02% |
| Measuring Range | 1.4 to 220 ng/mL serum | Same |
| Linearity Range | 1.4-229 ng/mL serum | 1.4-235 ng/mL serum |
| Tracer | 17-OHP-Eu tracer stock solution,approximate concentration of6 nmol/L, ready-to-use | 17-OHP-Eu tracer stock solution,approximate concentration of40 nmol/L, lyophilized |
| AnalyticalSensitivity / Limitof Blank, | Limit of Blank0.42 ng/mL serum | Limit of Blank0.37 ng/mL serum |
| Limit of Detection | Limit of Detection1.4 ng/mL serum | Limit of Detection0.84 ng/mL serum |
| Precision (TotalVariation using afull calibrationcurve on each plate) | 3.2 ng/mL serum CV% 14.95.3 ng/mL serum CV% 13.916.9 ng/mL serum CV% 11.351.6 ng/mL serum CV% 9.492.5 ng/mL serum CV% 10.9131 ng/mL serum CV% 10.1161 ng/mL serum CV% 10.9187 ng/mL serum CV% 12.0 | 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 |
| Expected Values inNewborns (perbirth weight and95th percentile) | < 1250 g 94.1 ng/mL serum1250-2249 g 47.5 ng/mL serum≥ 2250 g 13.8 ng/mL serum | Site 1:< 1250 g 73.6 ng/mL serum1250-2249 g 40.8 ng/mL serum≥ 2250 g 20.9 ng/mL serumSite 2:< 1250 g 95.0 ng/mL serum1250-2249 g 68.6 ng/mL serum≥ 2250 g 28.3 ng/mL serum |
| EndogenousInterferences | Icteric (unconjugated bilirubin ≤342 µmol/L, equivalent to 20mg/dL and conjugated bilirubin ≤237 µmol/L, equivalent to 20mg/dL),Hemolytic (additional hemoglobin≤ 0.5 g/dL),Lipemic (Intralipid ≤ 3000 mg/dLat 170HP levels of 30 and 70ng/mL and Intralipid ≤ 750 mg/dLat 170HP levels of 150 ng/mL)specimens do not interfere with theassay. | Icteric (unconjugated bilirubin ≤342 µmol/L, equivalent to 20mg/dL and conjugated bilirubin≤ 237 µmol/L, equivalent to 20mg/dL),Hemolytic (additionalhemoglobin ≤ 0.5 g/dL).Lipemic (Intralipid ≤ 3000mg/dL) specimens do notinterfere with the assay. |
| MethodComparison | The GSP kit (y) was compared to the AutoDELFIA kit (x) with 2567samples over a range of 1.4 - 220 ng/mL serum. Y= 0.97x + 0.27; r = 0.96; |
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Screening Efficacy:
The GSP kit and the predicate device were compared in one newborn screening laboratory using retrospective archived specimens and leftover samples from specimens submitted for routine screening. A total of 23 known CAH cases were included in the 2589 samples evaluated. The results are presented in tables 2 -7 using the 90th, 95th and 99th percentile cut-offs.
Table 1 Distribution of specimens into GSP and AutoDELFIA test results categories when using the highest 90% percentile cutoff. The agreement-%:s with 95% Cls are also presented (≥2500g).
| 90% cutoff | AutoDELFIA | ||
|---|---|---|---|
| GSP | Test Positive | Test Negative | Total |
| Test Positive | 165 | 39 | 204 |
| Test Negative | 36 | 1602 | 1638 |
| Total | 201 | 1641 | 1842 |
Overall percent agreement = (165+1602)/1842*100%= 95.9% (CI 94.9%.8%) Positive percent agreement = (165/201)*100% = 82.1% (CI 76.1%-87.1%) Negative percent agreement = (1602/1641)*100%= 97.6% (C1 96.8%-98.3%)
Table 2 Distribution of specimens into GSP and AutoDELFIA test results categories when using the highest 90% percentile cutoff. The agreement-%:s with 95% CIs are also presented (1250g-2249g).
| 90% cutoff | AutoDELFIA | ||
|---|---|---|---|
| GSP | Test Positive | Test Negative | Total |
| Test Positive | 42 | 3 | 45 |
| Test Negative | 3 | 391 | 394 |
| Total | 45 | 394 | 439 |
Overall percent agreement = (42+391)/(439)100% = 98.6% (CI 97.0%-99.5%) Positive percent agreement = (42/45) 100% = 93.3% (CI 81.7%-98.6%) Negative percent agreement = (391/394)*100%= 99.2% (C1 97.8%-99.8%)
Table 3 Distribution of specimens into GSP and AutoDELFIA test results categories when using the highest 90% percentile cutoff. The agreement-%:s with 95% CIs are also presented (<1250g).
| 90% cutoff | AutoDELFIA | ||
|---|---|---|---|
| GSP | Test Positive | Test Negative | Total |
| Test Positive | 25 | 6 | 31 |
| Test Negative | 6 | 271 | 277 |
| Total | 31 | 277 | 308 |
Overall percent agreement = (25+271)/(308)100% = 96.1% (C1 93.3%-98.0%) Positive percent agreement = (25/31) 100%= 80.6% (C1 62.5%-92.5%) Negative percent agreement = (271/277)* 100%= 97.8% (CI 95.3%-99.2%)
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Table 4 Distribution of specimens into GSP and AutoDELFIA test results categories when using the highest 95% percentile cutoff. The agreement-%:s with 95% CIs are also presented (≥2500g).
| 95% cutoff | AutoDELFIA | ||
|---|---|---|---|
| GSP | Test Positive | Test Negative | Total |
| Test Positive | 95 | 16 | 111 |
| Test Negative | 18 | 1713 | 1731 |
| Total | 113 | 1729 | 1842 |
Overall percent agreement = (95+1713)/1842*100%= 98.2% (CI 97.4%-98.7%) Positive percent agreement = (95/113)*100%=84.1% (CI 76.0%-90.3%) Negative percent agreement = (1713/1729)*100%= 99.1% (CI 98.5%-99.5%)
Table 5 Distribution of specimens into GSP and AutoDELFIA test results categories when using the highest 95% percentile cutoff. The agreement-%:s with 95% CIs are also presented (1250g-2249g).
| 95% cutoff | AutoDELFIA | ||
|---|---|---|---|
| GSP | Test Positive | Test Negative | Total |
| Test Positive | 20 | 3 | 23 |
| Test Negative | 3 | 413 | 416 |
| Total | 23 | 416 | 439 |
Overall percent agreement = (20+413)/439100% = 98.6% (Cl 97.0%-99.5%) Positive percent agreement = (20/23) 100% = 87.0% (C1 66.4%-97.2%) Negative percent agreement = (413/416)* 100%= 99.3% (CI 97.9%-99.9%)
Table 6 Distribution of specimens into GSP and AutoDELFIA test results categories when using the highest 95% percentile cutoff. The agreement-%:s with 95% CIs are also presented (<1250g).
| 95% cutoff | AutoDELFIA | ||
|---|---|---|---|
| GSP | Test Positive | Test Negative | Total |
| Test Positive | 11 | 5 | 16 |
| Test Negative | 5 | 287 | 292 |
| Total | 16 | 292 | 308 |
Overall percent agreement = (11+287)/308+100% = 96.8% (CI 94.1%-98.4%) Positive percent agreement = (11/16)* 100% = 68.8% (CI 41.3%-89.0%) Negative percent agreement = (287/292)*100%= 98.3% (C1 96.0%-99.4%)
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Table 7 Distribution of specimens into GSP and AutoDELFIA test results categories when using the highest 99% percentile cutoff. The agreement-%:s with 95% CIs are also presented (≥2500g).
| 99% cutoff | AutoDELFIA | ||
|---|---|---|---|
| GSP | Test Positive | Test Negative | Total |
| Test Positive | 39 | 2 | 41 |
| Test Negative | 1 | 1800 | 1801 |
| Total | 40 | 1802 | 1842 |
Overall percent agreement = (39+1800)/1842100%= 99.8% (CI 99.5%-100%) Positive percent agreement = (39/40) 100% = 97.5% (C1 86.8%-99.9%)
Negative percent agreement = (1800/1802)*100%= 99.9% (CI 99.6%-100%)
Table 8 Distribution of specimens into GSP and AutoDELFIA test results categories when using the highest 99% percentile cutoff. The agreement-%:s with 95% CIs are also presented (1250g-2249g).
| 99% cutoff | AutoDELFIA | ||
|---|---|---|---|
| GSP | Test Positive | Test Negative | Total |
| Test Positive | 2 | 4 | 6 |
| Test Negative | 4 | 429 | 433 |
| Total | 6 | 433 | 439 |
Overall percent agreement = (2+429)/439100% = 98.2% (CI 96.4%-99.2%) Positive percent agreement = (2/6) 100% = 33.3% (CI 4.3%-77.7%)
Negative percent agreement = (429/433)* 100%= 99.1% (CI 97.7%-99.7%)
Table I Distribution of specimens into GSP and AutoDELFIA test results categories when using the highest 99% percentile cutoff. The agreement-%:s with 95% CIs are also presented (<1250g).
| 99% cutoff | AutoDELFIA | ||
|---|---|---|---|
| GSP | Test Positive | Test Negative | Total |
| Test Positive | 4 | 0 | 4 |
| Test Negative | 0 | 304 | 304 |
| Total | 4 | 304 | 308 |
Overall percent agreement = (4+304)/308100%= 100% (CI 98.8%-100%) Positive percent agreement = (4/4) 100% = 100% (CI 39.8%-100%)
Negative percent agreement = (304/304)* 100%= 100% (CI 98.8%-100%)
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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Public Health Service
Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
Wallac Oy Subsidiary of PerkinElmer c/o Kay A. Taylor Director, Regulatory and Clinical Affairs 8275 Carloway Road Indianapolis, IN 46236
JUL 2 3 2010
K100682 Trade/Device Name: GSP Neonatal 17a-OH-progesterone kit (3305-001U) Regulation Number: 21 CFR 8862.1395 Regulation Name: 17-Hydroxyprogesterone Test System Regulatory Class: Class I; meets limitations of exemptions under 21 CFR § 862.9 (c)(2) Product Code: JLX Dated: June 3, 2010 Received: June 7, 2010
Dear Kay A. Taylor:
Re:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
CA
Courtney C. Harper, Ph.D. 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 Form
510(k) Number (if known): K100682
Device Name: GSP® Neonatal 17α-OH-progesterone kit (3305-001U)
Indications for Use:
The GSP Neonatal 17α-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 GSP™ instrument.
Prescription Use X (21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF 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) K100682
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.