Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard immunoassay for cortisol measurement and does not mention any AI or ML components. The performance studies are based on traditional analytical methods.

Therapeutic

No.
The device is an in vitro diagnostic (IVD) assay intended for the quantitative determination of cortisol to aid in diagnosis and treatment, not to directly treat a condition.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is intended for use as an aid in the diagnosis and treatment of adrenal disorders."

SaMD (Software as a Medical Device)

No

The device description clearly states it is a chemiluminescent microparticle immunoassay (CMIA) and mentions reagents and calibrators, indicating it is a hardware-based in vitro diagnostic device, not software only.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use explicitly states it's for the "quantitative determination of cortisol in human serum, plasma or urine". These are biological specimens taken from the human body.
Purpose: The assay is intended "for use as an aid in the diagnosis and treatment of adrenal disorders". This indicates a medical purpose related to diagnosing a condition.
Device Description: It describes a "chemiluminescent microparticle immunoassay (CMIA)" which is a common technology used in in vitro diagnostic tests.
Specimen Type: It analyzes "human serum, plasma or urine", which are all in vitro samples.

The definition of an In Vitro Diagnostic (IVD) device is a medical device that is used to examine specimens, such as blood, urine, or tissue, that have been taken from the human body to detect diseases, conditions, or infections. This device clearly fits that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes

JFT, JIT

Device Description

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®.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.
Results:

65 ug/dL Serum Pool: %DLP ranged from -8% to +4%.
8 ug/dL Serum Pool: %DLP ranged from -12% to +3%.

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.
Results:

Serum: % Recovery ranged from 86.1% to 98.5%.
Urine: % Recovery ranged from 84.6% to 100.9%.

Sensitivity:

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.
Results: 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.
The functional sensitivity of the ARCHITECT Cortisol assay was determined with guidance from CLSI guideline NCCLS EP17-A.
Results: 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.
Results: The results of the Method comparison study met the design goals and acceptance criteria.

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.
Results:

Serum: Total %CV ranged from 2.5% to 6.2%. (Acceptance Criteria 10% total CV serum)
Urine: Total %CV ranged from 3.8% to 6.4%. (Acceptance Criteria 20% total CV urine)

Interferences:
Interference studies were conducted using CLSI Guideline NCCLS EP7-A2: Interference Testing in Clinical Chemistry.
Results:

Serum Endogenous Substances: Bilirubin (+3.9%, +4.9%), Hemoglobin (-1.9%, +0.3%), Triglyceride (-7.8%, -5.9%), Total Protein (+4.6%, +13.2%, +11.1%, -6.7%).
Urine Endogenous Substances: Protein (-4.1%, -4.6%), Creatinine (2.2%, 2.4%), Urea (6.1%, 1.6%), Glucose (2.2%, 0.8%), NaCl (-2.0%, -3.3%), Boric Acid (2.0%, -1.9%).
HAMA: Grand Mean % Recovery 100.1% (Acceptance Criteria 100±15%).
Rheumatoid Factor (RF): Grand Mean % Recovery 94.1% (Acceptance Criteria 100±15%).
Anticoagulants: No significant difference between the recovery of Cortisol in serum or plasma.

Specificity:
Cortisol was spiked into cortisol free human serum at approximately 12ug/dL with cross reactants.
Results: % Cross Reactivity for various substances ranged from 0.0% to 36.8% (Fludrocortisone).

On-Board Stability:

Calibration Curve stability: A period of 30 days is supported by the data.
Reagent On-Board Stability: A 30 day on-board reagent stability claim is supported by the data.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Limit of Blank (LoB): ARCHITECT i2000 LoB= 0.234 µg/dL, ARCHITECT i2000SR LoB= 0.125 ug/dL
Limit of Detection (LoD): ARCHITECT i2000 LoD= 0.401ug/dL, ARCHITECT i2000SR LoD= 0.255ug/dL. Claimed LoD=0.8ug/dL.
Functional sensitivity (20% CV): lowest serum value 0.8ug/dL, lowest urine value 1ug/dL.
Accuracy (% Recovery): Serum 86.1% to 98.5%, Urine 84.6% to 100.9%.
Precision (Total %CV): Serum 2.5% to 6.2%, Urine 3.8% to 6.4%.

Predicate Device(s)

K033731

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 862.1205 Cortisol (hydrocortisone and hydroxycorticosterone) test system.

(a)
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.(b)
Classification. Class II.

Summary

0

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®.

1

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

| | Device
ARCHITECT Cortisol | Predicate
AxSYM Cortisol |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use
(Reagents) | ARCHITECT Cortisol is a chemiluminescent
microparticle immunoassay (CMIA) for the
quantitative determination of cortisol in
human serum, plasma or urine on the
ARCHITECT / System. The ARCHITECT
Cortisol assay is intended for use as an aid in
the diagnosis and treatment of adrenal
disorders. | The Cortisol assay is a Fluorescence
Polarization Immunoassay (FPIA) for the
quantitative measurement of cortisol in
human serum, plasma and urine on the
AxSYM System to aid in the diagnosis and
treatment of adrenal disorders. |
| Intended
Use
(Calibrators) | 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. | The AxSYM Cortisol Calibrators are for the
calibration of the Abbott AxSYM Cortisol
System to aid in the diagnosis and
treatment of adrenal disorders. |
| Indications
for Use | The results obtained are used to aid
diagnosis and treatment of adrenal disorders. | The results obtained are used to aid
diagnosis and treatment of adrenal
disorders. |
| Methodology | Heterogeneous chemiluminescent
microparticle immunoassay (CMIA). | Fluorescence Polarization Immunoassay
(FPIA) technology. |
| Reagent
Components | Two (2) reagent system:
• Microparticle Reagent with Anti-
Cortisol (mouse) coated Microparticles in
buffer with protein stabilizer, Proclin 300
and sodium azide.
• Conjugate Reagent with Cortisol
acridinium labeled conjugate in buffer with
surfactant stabilizer and Proclin 300. | Three (3) reagent system:
• Pretreatment Solution (P)
Surfactant in TRIS buffer and sodium
azide.
• Cortisol Antiserum (Mouse and
Goat) in buffer with protein stabilizer
and Sodium azide.
• Cortisol Fluorescein Tracer in
buffer containing surfactant and
stabilizers, and Sodium azide. |
| Calibration | ARCHITECT Cortisol Calibrators - six levels | AxSYM Cortisol Calibrators - six levels |

2

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
ug/dL | Predicted
1st
ug/dL | Predicted
2nd
ug/dL | difference
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

20%
Deviation |

65 ug/dL Serum Pool

8 ug/dL Serum Pool

| Dilution | Result
ug/dL | Predicted
1st
ug/dL | Predicted
2nd
ug/dL | difference
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

20%
Deviation |

3

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
5 ug/dL	12.5	12.7	98.5	17.8	18.2	97.6	16.4	17.1	95.7
Spiked
10 ug/dL	15.7	17.3	90.9	21.2	22.8	93.2	20.4	21.7	94.1
Spiked
20 ug/dL	23.7	26.4	89.6	28.7	31.8	90.2	28.4	30.8	92.3
Spiked
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
5 ug/dL	10.4	10.3	100.9	25.1	26.4	94.9	16.1	16.4	97.9
Spiked
10 ug/dL	14.0	14.9	93.8	29.5	30.9	95.5	19.3	21.0	91.9
Spiked
20 ug/dL	22.2	24.1	92.0	34.6	39.8	87.0	27.6	30.1	91.7
Spiked
40 ug/dL	36.0	42.6	84.6	52.0	57.6	90.3	41.2	48.3	85.3

Serum

4

Sensitivity

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.

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.

5

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
Conc.
ug/dL | Within Run | | Between Day | | Total | |
|---------------|-----------------|-------------|----|------------------------|------------------|------------|------------------|------------|------------------|------------|
| | | | | | SD | %CV | SD | %CV | SD | %CV |
| MCC 1 | I2000
I2000S | A
B | 80 | 3.8
4.0 | 0.1369
0.1924 | 3.6
4.8 | 0.1315
0.0000 | 3.4
0.0 | 0.1898
0.2321 | 5.0
5.8 |
| MCC 2 | I2000
I2000S | A
B | 80 | 16.6
17.3 | 0.4300
0.4000 | 2.6
2.3 | 0.4071
0.5459 | 2.5
3.2 | 0.6184
1.3228 | 3.7
7.7 |
| MCC 3 | I2000
I2000S | A
B | 80 | 30.3
31.0 | 0.8739
0.6344 | 2.9
2.1 | 0.6784
1.1223 | 2.2
3.6 | 1.1695
1.3178 | 3.9
4.3 |
| Serum panel 1 | I2000
I2000S | A
B | 80 | 2.9
2.9 | 0.0829
0.1601 | 2.9
5.5 | 0.0000
0.0835 | 0.0
2.9 | 0.1140
0.1806 | 4.0
6.2 |
| Serum panel 2 | I2000
I2000S | A
B | 80 | 39.8
41.0 | 0.9526
1.0822 | 2.4
2.6 | 0.0000
0.4470 | 0.0
1.2 | 1.0065
1.2947 | 2.5
3.2 |
| Serum panel 3 | I2000
I2000S | A
B | 80 | 53.3
55.8 | 1.7061
1.5047 | 3.2
2.7 | 0.2887
0.9540 | 0.5
1.7 | 1.7303
1.8730 | 3.3
3.4 |
| Urine panel 1 | I2000
I2000S | A
B | 80 | 2.4
2.7 | 0.1270
0.1636 | 5.3
6.1 | 0.0545
0.0463 | 2.3
1.7 | 0.1482
0.1700 | 6.2
6.4 |
| Urine panel 2 | I2000
I2000S | A
B | 80 | 14.5
15.9 | 0.3927
0.6039 | 2.7
3.8 | 0.0000
0.3916 | 0.0
2.5 | 0.5875
0.7198 | 4.1
4.5 |
| Urine panel 3 | I2000
I2000S | A
B | 80 | 36.8
40.6 | 1.0509
1.5605 | 2.9
3.9 | 0.5742
0.3012 | 1.6
0.7 | 1.3916
1.5893 | 3.8
3.9 |
| Urine panel 4 | I2000
I2000S | A
B | 80 | 49.0
53.7 | 2.8402
3.1812 | 5.8
5.9 | 0.0000
0.0000 | 0.0
0.0 | 2.8402
3.1812 | 5.8
5.9 |

eptance Criteria 0% total CV serum

:20% total CV urine

6

Interferences

Interference studies were conducted using CLSI Guideline NCCLS EP7-A2: Interference Testing in Clinical Chemistry.

:

A. Endogenous Substances

1) Serum

| Interfering
Substance | Interferent
Concentration | N | Target
µg/mL | Mean Recovery
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
of Interferant | Mean
Recovery
Endogenous
Cortisol only | %
Interference | Mean
Recovery
Cortisol
Spiked | %
Interference |
|----------------------------|---------------------------------|-------------------------------------------------|-------------------|----------------------------------------|-------------------|
| Unaltered
Urine Control | N/A | 4.9 | N/A | 36.9 | N/A |
| Mock
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 |

:

7

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
ug/dL | Spiked with
Cortisol ug/dL | Spiked with
cortisol-free
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
100±15% | | 100.1 |

C. Rheumatoid Factor (RF)

Ten positive RF patient samples were assayed for cortisol concentration.

| Sample | Native
Cortisol
ug/dL | Spiked Cortisol
ug/dL | Spiked with
cortisol-free
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
100±15% | 94.1 |

8

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 ug/dL | % Cross
Reactivity | Cross Reactant ug/dL | % Cross
Reactivity |
|--------------------------|----- | 11-beta-OH-progesterone | 1000 | 11-deoxycorticosterone | 100 | 11-deoxycortisol | 100 | 17-alpha-OH Pregnenolone | 1000 | 17-OH-progesterone | 1000 | 6-beta-OH cortisol | 1000 | 6-methyl- prednisolone | 1000 | Aldosterone | 1000 | Beclomethasone | 1000 | beta-cortol | 1000 | beta-cortolone | 1000 | Beta-Estradiol | 1000 | beta-Sitosterol | 1000 | Budesonide | 1000 | Canrenone | 1000 | Corticosterone | 1000 | Cortisol-21-glucuronide | 1000 | Cortisone | 1000 | Dexamethasone | 1000 | DHEA | 1000 | DHEA-S | 1000 | Estriol | 1000 | Estrone | 1000 | Fludrocortisone | 100 | Fluticasone Propionate | 1000 | Medroxy Progesterone | 1000 | Acetate | | Mometasone | 1000 | Prednisolone | 100 | Prednisone | 1000 | Test conc
| Test conc
---------------|-----------------------|--------------------|--------------------|-----------------------|
| 0.2 | Pregnanediol | 1000 | 0.0 |
| 0.1 | Pregnanetriol | 1000 | 0.0 |
| 2.1 | Pregnenolone | 1000 | 0.0 |
| 0.1 | Progesterone | 1000 | 0.1 |
| 0.6 | Spironolactone | 1000 | 0.0 |
| 0.2 | Testosterone | 1000 | 0.1 |
| 0.1 | Tetracycline | 1000 | 0.0 |
| 0.0 | Tetrahydrocortisol | 1000 | 0.6 |
| 0.0 | Triamcinolone | 1000 | 0.4 |
| 0.0 | | | |
| 0.0 | | | |
| 0.0 | | | |
| 0.0 | | | |
| 0.0 | | | |
| 0.1 | | | |
| 0.9 | | | |
| 0.2 | | | |
| 2.8 | | | |
| 0.0 | | | |
| 0.0 | | | |
| 0.0 | | | |
| 0.0 | | | |
| 0.0 | | | |
| 36.8 | | | |
| 0.0 | | | |
| 0.0 | | | |
| | | | |
| 0.0 | | | |
| 12.5 | | | |
| 0.6 | | | |

9

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.

10

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).

11

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

12

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)

Division Sign-Off	for Carol Benson
-------------------	-------------------------------------------------------------

Office of In Vitro Diagnostic Device
Evaluation and Safety... 127622-0-1