ARCHITECT CORTISOL ASSAY
Device Facts
| Record ID | K062204 |
|---|---|
| Device Name | ARCHITECT CORTISOL ASSAY |
| Applicant | Seradyn, Inc. |
| Product Code | JFT · Clinical Chemistry |
| Decision Date | Sep 22, 2006 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1205 |
| Device Class | Class 2 |
Intended Use
The ARCHITECT Cortisol is a chemiluminescent microparticle immunoassay (CIMA) for the quantitative determination of cortisol in human serum, plasma or urine on the ARCHITECT i System. The ARCHITECT Cortisol assay is intended for use as an aid in the diagnosis and treatment of adrenal disorders. The ARCHITECT Cortisol Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of Cortisol in human serum, plasma or urine.
Device Story
ARCHITECT Cortisol is a delayed one-step chemiluminescent microparticle immunoassay (CMIA) used on the ARCHITECT i System. It measures cortisol levels in human serum, plasma, or urine samples. The assay utilizes anti-cortisol coated microparticles and acridinium-labeled cortisol conjugate. The system automates the immunoassay process, providing quantitative results to clinicians. These results assist in the diagnosis and treatment of adrenal disorders. The device is intended for professional use in clinical laboratory settings.
Clinical Evidence
Bench testing only. Precision studies (n=80 replicates per sample) showed total CV <10% for serum and <20% for urine. Linearity confirmed 0.49-65.9 µg/dL. Functional sensitivity (20% CV) established at 0.8 µg/dL (serum) and 1.0 µg/dL (urine). Method comparison against predicate and LC-MS/MS showed high correlation (r ≥ 0.97). Interference and cross-reactivity studies performed per CLSI guidelines.
Technological Characteristics
Heterogeneous chemiluminescent microparticle immunoassay (CMIA). Reagents include anti-cortisol (mouse) coated microparticles and acridinium-labeled cortisol conjugate. Uses Chemiflex® flexible assay protocols. Operates on the ARCHITECT i System. Calibration uses six-level calibrators. Stabilizers include Proclin 300 and sodium azide.
Indications for Use
Indicated for the quantitative determination of cortisol in human serum, plasma, or urine to aid in the diagnosis and treatment of adrenal disorders. For prescription use only.
Regulatory Classification
Identification
A cortisol (hydrocortisone and hydroxycorticosterone) test system is a device intended to measure the cortisol hormones secreted by the adrenal gland in plasma and urine. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.
Predicate Devices
- AXSYM® CORTISOL REAGENTS AND CALIBRATORS (K033731)
Related Devices
- K984520 — NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL IMMUNOASSAY, MODEL 62-7005 · Nichols Institute Diagnostics · Feb 5, 1999
- K202136 — IDS Cortisol · Immunodiagnostic Systems , Ltd. · Apr 13, 2021
- K042689 — NICHOLS ADVANTAGE CORTISOL · Nichols Institute Diagnostics · Dec 9, 2004
- K021218 — ELECSYS CORTISOL TEST SYSTEM · Roche Diagnostics Corp. · Sep 9, 2002
Submission Summary (Full Text)
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#### 510K 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
k 062204 The assigned 510(k) number is:
### COMPANY/CONTACT PERSON
Seradyn, Inc 7998 Georgetown Road, Suite 1000 Indianapolis, IN 46268
Establishment registration No: 1836010
Earl E. Knight III, MPA Regulatory Affairs Associate Telephone: (317) 554-0639 Fax: (317) 610-0018
### DATE PREPARED
July 27, 2006
### DEVICE NAME
| Trade Name: | ARCHITECT Cortisol |
|------------------------|--------------------------------------------------------------------------------------------|
| Common Name: | Fluorometric, Cortisol |
| Device Classification: | 21 CFR 862.1205; Cortisol (hydrocortisone and hydroxycorticosterone) test system; Class II |
| Trade Name: | ARCHITECT Cortisol Calibrators |
| Common Name: | Calibrator, Secondary |
| Device Classification: | 21 CFR 862.1150; Cortisol (calibrator) test system; Class II |
### Intended use
ARCHITECT® Cortisol is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of cortisol in human serum, plasma or urine on the ARCHITECT i System. The ARCHITECT Cortisol assay is intended for use as an aid in the diagnosis and treatment of adrenal disorders.
The ARCHITECT Cortisol Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of cortisol in human serum, plasma or urine.
#### Legally marketed device to which equivalency is claimed
AXSYM® CORTISOL REAGENTS AND CALIBRATORS (K033731)
### DESCRIPTION OF DEVICE
The ARCHITECT Cortisol assay is a delayed one-step immunoassay for the quantitative determination of cortisol in human serum, plasma or urine using CMIA technology with flexible assay protocols, referred to as Chemiflex®.
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# COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
| | Device<br>ARCHITECT Cortisol | Predicate<br>AxSYM Cortisol |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use<br>(Reagents) | ARCHITECT Cortisol is a chemiluminescent<br>microparticle immunoassay (CMIA) for the<br>quantitative determination of cortisol in<br>human serum, plasma or urine on the<br>ARCHITECT / System. The ARCHITECT<br>Cortisol assay is intended for use as an aid in<br>the diagnosis and treatment of adrenal<br>disorders. | The Cortisol assay is a Fluorescence<br>Polarization Immunoassay (FPIA) for the<br>quantitative measurement of cortisol in<br>human serum, plasma and urine on the<br>AxSYM System to aid in the diagnosis and<br>treatment of adrenal disorders. |
| Intended<br>Use<br>(Calibrators) | The ARCHITECT® Cortisol Calibrators are<br>for the calibration of the ARCHITECT i<br>System when used for the quantitative<br>determination of cortisol in human serum,<br>plasma or urine. | The AxSYM Cortisol Calibrators are for the<br>calibration of the Abbott AxSYM Cortisol<br>System to aid in the diagnosis and<br>treatment of adrenal disorders. |
| Indications<br>for Use | The results obtained are used to aid<br>diagnosis and treatment of adrenal disorders. | The results obtained are used to aid<br>diagnosis and treatment of adrenal<br>disorders. |
| Methodology | Heterogeneous chemiluminescent<br>microparticle immunoassay (CMIA). | Fluorescence Polarization Immunoassay<br>(FPIA) technology. |
| Reagent<br>Components | Two (2) reagent system:<br>• Microparticle Reagent with Anti-<br>Cortisol (mouse) coated Microparticles in<br>buffer with protein stabilizer, Proclin 300<br>and sodium azide.<br>• Conjugate Reagent with Cortisol<br>acridinium labeled conjugate in buffer with<br>surfactant stabilizer and Proclin 300. | Three (3) reagent system:<br>• Pretreatment Solution (P)<br>Surfactant in TRIS buffer and sodium<br>azide.<br>• Cortisol Antiserum (Mouse and<br>Goat) in buffer with protein stabilizer<br>and Sodium azide.<br>• Cortisol Fluorescein Tracer in<br>buffer containing surfactant and<br>stabilizers, and Sodium azide. |
| Calibration | ARCHITECT Cortisol Calibrators - six levels | AxSYM Cortisol Calibrators - six levels |
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# SUMMARY OF CLINICAL TESTING
### Linearity
Linearity by Dilution was determined by a study based on the NCCLS guideline EP6- A: Evaluation of the Linearity of Quantitative Measurement.
A regression analysis plot of recovered cortisol against dilution factor was constructed. r regression and regression standard error (Reg SE) were examined for each pool. The second order polynomial regression was chosen and the percent deviation from linearity (%DLP) calculated from the porynomial regroom was onsoon and the pon and compared to the predicted first order polynomial (linear) regression.
| Dilution | Result<br>ug/dL | Predicted<br>1st<br>ug/dL | Predicted<br>2nd<br>ug/dL | difference<br>ug/dL | % DLP |
|----------|-----------------|---------------------------|---------------------------|---------------------|------------------------------|
| 100% | N/A | N/A | N/A | N/A | N/A |
| 90% | 65.85 | 64.60 | 66.17 | -1.6 | -2% |
| 80% | 58.41 | 57.28 | 57.80 | -0.5 | -1% |
| 70% | 49.69 | 49.96 | 49.70 | 0.3 | 1% |
| 60% | 41.92 | 42.64 | 41.85 | 0.8 | 2% |
| 50% | 33.69 | 35.31 | 34.27 | 1.0 | 3% |
| 40% | 26.74 | 27.99 | 26.95 | 1.0 | 4% |
| 30% | 19.72 | 20.67 | 19.89 | 0.8 | 4% |
| 20% | 14.02 | 13.35 | 13.09 | 0.3 | 2% |
| 10% | 6.53 | 6.03 | 6.55 | -0.5 | -8% |
| 0% | -0.04 | -1.30 | 0.27 | -1.6 | Target<br>+ 20%<br>Deviation |
### 65 ug/dL Serum Pool
### 8 ug/dL Serum Pool
| Dilution | Result<br>ug/dL | Predicted<br>1st<br>ug/dL | Predicted<br>2nd<br>ug/dL | difference<br>ug/dL | % DLP |
|----------|-----------------|---------------------------|---------------------------|---------------------|------------------------------|
| 100% | 7.79 | 7.66 | 7.81 | -0.2 | -2% |
| 90% | 7.01 | 6.86 | 6.92 | -0.1 | -1% |
| 80% | 5.87 | 6.07 | 6.06 | 0.0 | 0% |
| 70% | 5.27 | 5.27 | 5.21 | 0.1 | 1% |
| 60% | 4.43 | 4.48 | 4.39 | 0.1 | 2% |
| 50% | 3.68 | 3.69 | 3.58 | 0.1 | 3% |
| 40% | 2.83 | 2.89 | 2.80 | 0.1 | 3% |
| 30% | 2.03 | 2.10 | 2.04 | 0.1 | 3% |
| 20% | 1.16 | 1.30 | 1.29 | 0.0 | 1% |
| 10% | 0.49 | 0.51 | 0.57 | -0.1 | -12% |
| 0% | -0.01 | -0.28 | -0.13 | -0.2 | Target<br>+ 20%<br>Deviation |
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### Accuracy
Accuracy by Recovery was determined by spiking cortisol into human serum and urine to achieve
concentrations across the range of the assay. The samples were analyzed in trip ARCHITECT Cortisol assay.
| | Donor 1 | | | Donor 2 | | | Donor 3 | | |
|--------------------|----------|----------|------------|----------|----------|------------|----------|----------|------------|
| | Observed | Expected | % Recovery | Observed | Expected | % Recovery | Observed | Expected | % Recovery |
| Unspiked | 8.1 | N/A | N/A | 13.7 | N/A | N/A | 12.6 | N/A | N/A |
| Spiked<br>5 ug/dL | 12.5 | 12.7 | 98.5 | 17.8 | 18.2 | 97.6 | 16.4 | 17.1 | 95.7 |
| Spiked<br>10 ug/dL | 15.7 | 17.3 | 90.9 | 21.2 | 22.8 | 93.2 | 20.4 | 21.7 | 94.1 |
| Spiked<br>20 ug/dL | 23.7 | 26.4 | 89.6 | 28.7 | 31.8 | 90.2 | 28.4 | 30.8 | 92.3 |
| Spiked<br>40 ug/dL | 39.5 | 44.8 | 88.2 | 43.0 | 49.9 | 86.1 | 43.2 | 48.9 | 88.3 |
100 + 15%
larget Recovery 100 + 20%
| Urine | Donor 1 | | | Donor 2 | | | Donor 3 | | |
|--------------------|----------|----------|------------|----------|----------|------------|----------|----------|------------|
| | Observed | Expected | % Recovery | Observed | Expected | % Recovery | Observed | Expected | % Recovery |
| Unspiked | 5.7 | N/A | N/A | 22.0 | N/A | N/A | 11.9 | N/A | N/A |
| Spiked<br>5 ug/dL | 10.4 | 10.3 | 100.9 | 25.1 | 26.4 | 94.9 | 16.1 | 16.4 | 97.9 |
| Spiked<br>10 ug/dL | 14.0 | 14.9 | 93.8 | 29.5 | 30.9 | 95.5 | 19.3 | 21.0 | 91.9 |
| Spiked<br>20 ug/dL | 22.2 | 24.1 | 92.0 | 34.6 | 39.8 | 87.0 | 27.6 | 30.1 | 91.7 |
| Spiked<br>40 ug/dL | 36.0 | 42.6 | 84.6 | 52.0 | 57.6 | 90.3 | 41.2 | 48.3 | 85.3 |
Serum
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### Sensitivity
1) The limit of blank (LoB) and the LoD were determined with guidance from CLSI guideline NCCLS EP17-A: Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline using proportions of false positives (α) less than 5% and false negatives (β) less than 5%. These determinations were performed using 60 blank and 120 low level samples.
ARCHITECT i2000 LoB= 0.234 µg/dL and LoD= 0.401ug/dL ARCHITECT i2000SR LoB= 0.125 ug/dL and LoD= 0.255ug/dL
An assay claim of LoD=0.8ug/dL is supported by the data.
2) The functional sensitivity of the ARCHITECT Cortisol assay was determined with guidance from CLSI guideline NCCLS EP17-A.
At the upper 95% confidence limit, the lowest serum value exhibiting a 20% CV was calculated to be 0.8ug/dL. At the upper 95% confidence limit, the lowest urine value exhibiting a 20% CV was calculated to be 1ug/dL.
### Method Comparison
The studies were conducted according to CLSI Guideline NCCLS EP9: Method Comparison and Bias Estimation Using Patient Samples to compare accuracy of Cortisol in serum and urine assayed by the ARCHITECT Cortisol assay to the Abbott AxSYM® Cortisol assay.
The results of the Method comparison study met the design goals and acceptance criteria.
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# Precision
A precision study was performed using the National Committee for Clinical Laboratory Standards (NCCLS)
guideline EP5-A2: Evaluation of Precision Performance of Clinical Chemi
| Sample | Instr. | Reagent Lot | n | Mean<br>Conc.<br>ug/dL | Within Run | | Between Day | | Total | |
|---------------|-----------------|-------------|----|------------------------|------------------|------------|------------------|------------|------------------|------------|
| | | | | | SD | %CV | SD | %CV | SD | %CV |
| MCC 1 | I2000<br>I2000S | A<br>B | 80 | 3.8<br>4.0 | 0.1369<br>0.1924 | 3.6<br>4.8 | 0.1315<br>0.0000 | 3.4<br>0.0 | 0.1898<br>0.2321 | 5.0<br>5.8 |
| MCC 2 | I2000<br>I2000S | A<br>B | 80 | 16.6<br>17.3 | 0.4300<br>0.4000 | 2.6<br>2.3 | 0.4071<br>0.5459 | 2.5<br>3.2 | 0.6184<br>1.3228 | 3.7<br>7.7 |
| MCC 3 | I2000<br>I2000S | A<br>B | 80 | 30.3<br>31.0 | 0.8739<br>0.6344 | 2.9<br>2.1 | 0.6784<br>1.1223 | 2.2<br>3.6 | 1.1695<br>1.3178 | 3.9<br>4.3 |
| Serum panel 1 | I2000<br>I2000S | A<br>B | 80 | 2.9<br>2.9 | 0.0829<br>0.1601 | 2.9<br>5.5 | 0.0000<br>0.0835 | 0.0<br>2.9 | 0.1140<br>0.1806 | 4.0<br>6.2 |
| Serum panel 2 | I2000<br>I2000S | A<br>B | 80 | 39.8<br>41.0 | 0.9526<br>1.0822 | 2.4<br>2.6 | 0.0000<br>0.4470 | 0.0<br>1.2 | 1.0065<br>1.2947 | 2.5<br>3.2 |
| Serum panel 3 | I2000<br>I2000S | A<br>B | 80 | 53.3<br>55.8 | 1.7061<br>1.5047 | 3.2<br>2.7 | 0.2887<br>0.9540 | 0.5<br>1.7 | 1.7303<br>1.8730 | 3.3<br>3.4 |
| Urine panel 1 | I2000<br>I2000S | A<br>B | 80 | 2.4<br>2.7 | 0.1270<br>0.1636 | 5.3<br>6.1 | 0.0545<br>0.0463 | 2.3<br>1.7 | 0.1482<br>0.1700 | 6.2<br>6.4 |
| Urine panel 2 | I2000<br>I2000S | A<br>B | 80 | 14.5<br>15.9 | 0.3927<br>0.6039 | 2.7<br>3.8 | 0.0000<br>0.3916 | 0.0<br>2.5 | 0.5875<br>0.7198 | 4.1<br>4.5 |
| Urine panel 3 | I2000<br>I2000S | A<br>B | 80 | 36.8<br>40.6 | 1.0509<br>1.5605 | 2.9<br>3.9 | 0.5742<br>0.3012 | 1.6<br>0.7 | 1.3916<br>1.5893 | 3.8<br>3.9 |
| Urine panel 4 | I2000<br>I2000S | A<br>B | 80 | 49.0<br>53.7 | 2.8402<br>3.1812 | 5.8<br>5.9 | 0.0000<br>0.0000 | 0.0<br>0.0 | 2.8402<br>3.1812 | 5.8<br>5.9 |
eptance Criteria 0% total CV serum
:20% total CV urine
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# Interferences
Interference studies were conducted using CLSI Guideline NCCLS EP7-A2: Interference Testing in Clinical Chemistry.
:
# A. Endogenous Substances
# 1) Serum
| Interfering<br>Substance | Interferent<br>Concentration | N | Target<br>µg/mL | Mean Recovery<br>µg/mL | % Interference |
|--------------------------|------------------------------|---|-----------------|------------------------|----------------|
| Bilirubin | 20mg/dL | 3 | 5.1 | 5.3 | +3.9 |
| | | | 28.4 | 29.8 | +4.9 |
| Hemoglobin | 10g/dL | 3 | 5.3 | 5.2 | -1.9 |
| | | | 29.4 | 30.6 | +0.3 |
| Triglyceride | 2000 mg/dL | 3 | 5.1 | 4.7 | -7.8 |
| | | | 28.8 | 27.1 | -5.9 |
| Total Protein | 10 g/dL | 3 | 10.9 | 11.4 | +4.6 |
| | | | 34.2 | 38.7 | +13.2 |
| Total Protein | 3 g/dL | 3 | 8.1 | 9.0 | +11.1 |
| | | | 31.4 | 29.3 | -6.7 |
# 2) Urine
・
| % Interferant | Concentration<br>of Interferant | Mean<br>Recovery<br>Endogenous<br>Cortisol only | %<br>Interference | Mean<br>Recovery<br>Cortisol<br>Spiked | %<br>Interference |
|----------------------------|---------------------------------|-------------------------------------------------|-------------------|----------------------------------------|-------------------|
| Unaltered<br>Urine Control | N/A | 4.9 | N/A | 36.9 | N/A |
| Mock<br>spike Control | N/A | 4.6 | N/A | 37.9 | N/A |
| Protein | 1000mg/dL | 5.1 | -4.1 | 38.6 | -4.6 |
| Creatinine | 5mmol/L | 4.5 | 2.2 | 37.0 | 2.4 |
| Urea | 350mmol/L | 4.6 | 6.1 | 36.3 | 1.6 |
| Glucose | 5mmol/L | 4.5 | 2.2 | 37.6 | 0.8 |
| NaCl | 1000mmol/L | 5.0 | -2.0 | 38.1 | -3.3 |
| Boric Acid | 1% | 4.8 | 2.0 | 37.6 | -1.9 |
:
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### B. HAMA
As with any assay employing mouse antibodies, the possibility exists for interference by human anti-mouse antibodies (HAMA) in the sample, which could cause falsely elevated results.
| Sample | Native Cortisol<br>ug/dL | Spiked with<br>Cortisol ug/dL | Spiked with<br>cortisol-free<br>serum ug/dL | % Recovery |
|--------|--------------------------|--------------------------------|---------------------------------------------|------------|
| 1 | 4.9 | 10.1 | 4.7 | 101.0 |
| 2 | 11.2 | 21.8 | 10.2 | 102.8 |
| 3 | 11.5 | 21.2 | 10.6 | 98.1 |
| 4 | 8.7 | 13.9 | 8.4 | 101.5 |
| 5 | 6.6 | 11.7 | 6.4 | 100.0 |
| 6 | 19.9 | 29.7 | 18.6 | 100.3 |
| 7 | 18.3 | 28.8 | 17.9 | 99.7 |
| 8 | 9.7 | 14.7 | 9.4 | 100.0 |
| HAMA-1 | 8.6 | 13.8 | 8.5 | 100.0 |
| HAMA-2 | 8.0 | 13.5 | 8.5 | 97.8 |
| | Grand Mean % Recovery | Acceptance Criteria<br>100±15% | | 100.1 |
# C. Rheumatoid Factor (RF)
Ten positive RF patient samples were assayed for cortisol concentration.
| Sample | Native<br>Cortisol<br>ug/dL | Spiked Cortisol<br>ug/dL | Spiked with<br>cortisol-free<br>serum ug/dL | % Recovery |
|-----------------------|-----------------------------|--------------------------|---------------------------------------------|------------|
| 1 | 11.1 | 19.4 | 10.5 | 92.4 |
| 2 | 5.0 | 10.0 | 4.9 | 90.9 |
| 3 | 11.0 | 20.5 | 11.3 | 94.0 |
| 4 | 34.0 | 41.8 | 33.6 | 94.8 |
| 5 | 17.3 | 24.9 | 16.2 | 93.3 |
| 6 | 5.4 | 10.9 | 5.5 | 94.0 |
| 7 | 14.1 | 21.8 | 13.8 | 89.7 |
| 8 | 3.0 | 8.6 | 2.9 | 95.6 |
| 9 | 23.8 | 31.8 | 23.4 | 93.8 |
| 10 | 13.8 | 24.1 | 13.1 | 102.1 |
| Grand Mean % Recovery | | | Acceptance Criteria<br>100±15% | 94.1 |
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### D. Anticoagulants
Studies were conducted to determine the performance characteristics of the assay for both serum and plasma samples containing Cortisol.
The results indicate that there is no significant difference between the recovery of Cortisol in serum or plasma. The collection tubes evaluated show no adverse effects on the recovery of Cortisol, within the experimental error for the spiking study.
A claim for assay application to both serum and plasma samples is thus supported.
# Specificity
Cortisol was spiked into cortisol free human serum at approximately 12ug/dL. Cross reactant stock concentrates were prepared in solvent and spiked into aliquots of the 12ug/dL cortisol serum to achieve cross reactant concentrations of 100 or 1000ug/dL. A control aliquot was prepared for each solvent system by spiking the solvent into the 12ug/dL cortisol serum at the same volume used with the cross reactant stocks.
| Cross Reactant | Test conc<br>ug/dL | % Cross<br>Reactivity | Cross Reactant | Test conc<br>ug/dL | % Cross<br>Reactivity |
|--------------------------|--------------------|-----------------------|--------------------|--------------------|-----------------------|
| 11-beta-OH-progesterone | 1000 | 0.2 | Pregnanediol | 1000 | 0.0 |
| 11-deoxycorticosterone | 100 | 0.1 | Pregnanetriol | 1000 | 0.0 |
| 11-deoxycortisol | 100 | 2.1 | Pregnenolone | 1000 | 0.0 |
| 17-alpha-OH Pregnenolone | 1000 | 0.1 | Progesterone | 1000 | 0.1 |
| 17-OH-progesterone | 1000 | 0.6 | Spironolactone | 1000 | 0.0 |
| 6-beta-OH cortisol | 1000 | 0.2 | Testosterone | 1000 | 0.1 |
| 6-methyl- prednisolone | 1000 | 0.1 | Tetracycline | 1000 | 0.0 |
| Aldosterone | 1000 | 0.0 | Tetrahydrocortisol | 1000 | 0.6 |
| Beclomethasone | 1000 | 0.0 | Triamcinolone | 1000 | 0.4 |
| beta-cortol | 1000 | 0.0 | | | |
| beta-cortolone | 1000 | 0.0 | | | |
| Beta-Estradiol | 1000 | 0.0 | | | |
| beta-Sitosterol | 1000 | 0.0 | | | |
| Budesonide | 1000 | 0.0 | | | |
| Canrenone | 1000 | 0.1 | | | |
| Corticosterone | 1000 | 0.9 | | | |
| Cortisol-21-glucuronide | 1000 | 0.2 | | | |
| Cortisone | 1000 | 2.8 | | | |
| Dexamethasone | 1000 | 0.0 | | | |
| DHEA | 1000 | 0.0 | | | |
| DHEA-S | 1000 | 0.0 | | | |
| Estriol | 1000 | 0.0 | | | |
| Estrone | 1000 | 0.0 | | | |
| Fludrocortisone | 100 | 36.8 | | | |
| Fluticasone Propionate | 1000 | 0.0 | | | |
| Medroxy Progesterone | 1000 | 0.0 | | | |
| Acetate | | | | | |
| Mometasone | 1000 | 0.0 | | | |
| Prednisolone | 100 | 12.5 | | | |
| Prednisone | 1000 | 0.6 | | | |
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# On-Board Stability
### 1) Calibration Curve stability
Calibration curve stability of a period of 30 days is supported by the data.
### 2) Reagent On-Board Stability
A 30 day on-board reagent stability claim is supported by the data.
# CONCLUSION
The ARCHITECT Cortisol assay has been shown to be substantially equivalent to the Abbott AxSYM Cortisol assay through the following performance testing verifies that the device functions as intended and that design specifications have been satisfied.
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Image /page/10/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 1 9 2006
Mr. Jack Rogers Manager of Regulatory Affairs Seradyn. Inc. 7998 Georgetown Rd., Suite 1000 Indianapolis, IN 46268
k062204 Re: Trade/Device Name: ARCHITECT Cortisol Regulation Number: 21 CFR 862.1205 Regulation Name: Cortisol (hydrocortisone and hydroxycorticosterone) test system Regulatory Class: Class II Product Code: JFT, JIT Dated: July 31, 2006 Received: August 3, 2006
Dear Mr. Rogers,
This letter corrects our substantially equivalent letter of 9/22/2006.
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) 276-0484. 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/industry/support/index.html.
Sincerely yours,
Alberto Garcia
Alberto Gutierrez, 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
k 062204 510(k) Number (if known):
ARCHITECT Cortisol Device Name:
# Indications for Use:
ARCHITECT Cortisol is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of cortisol in human serum, plasma or urine on for the ARCHITECT i System. The ARCHITECT Cortisol assay is intended for use as an aid in the diagnosis and treatment of adrenal disorders.
The ARCHITECT Cortisol Calibrators are for the calibration of the ARCHITECT i The AROFINEST OURSET Suantitative determination of cortisol in human serum, plasma or urine.
Prescription Use X ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
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Office of In Vitro Diagnostic Device
Evaluation and Safety... 127622-0-1
