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.

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®.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the ARCHITECT Cortisol assay:

1. Table of Acceptance Criteria and Reported Device Performance:

Test Category	Acceptance Criteria	Reported Device Performance
Linearity	Target +/- 20% Deviation (at 0% dilution for both serum pools)	- 65 ug/dL Serum Pool: %DLP ranged from -8% to 4% for diluted samples. At the 0% dilution, the difference was-1.6 ug/dL, compared to the target value of N/A, which is acceptable relative to the ±20% deviation criteria. - 8 ug/dL Serum Pool: %DLP ranged from -12% to 3% for diluted samples. At the 0% dilution, the difference was-0.2 ug/dL, which is acceptable relative to the ±20% deviation criteria.
Accuracy (Recovery)	Serum: Target Recovery 100 ± 15% Urine: Target Recovery 100 ± 20%	- Serum: % Recovery ranged from 86.1% to 98.5%. All values are within the acceptance criteria of 100 ± 15% (i.e., 85% to 115%). - Urine: % Recovery ranged from 84.6% to 100.9%. All values are within the acceptance criteria of 100 ± 20% (i.e., 80% to 120%).
Sensitivity (LoD)	Assay claim of LoD = 0.8 ug/dL is supported by data.	- ARCHITECT i2000 LoD = 0.401 ug/dL - ARCHITECT i2000SR LoD = 0.255 ug/dL - Functional sensitivity (20% CV): Serum = 0.8 ug/dL, Urine = 1 ug/dL. All reported LoD values are less than or equal to the claimed 0.8 ug/dL for serum, and urine is close at 1 ug/dL, thus supporting the claim.
Method Comparison	The results of the Method comparison study met the design goals and acceptance criteria. (Specific numerical criteria not provided in the summary)	The summary states that "The results of the Method comparison study met the design goals and acceptance criteria." No specific numerical values for agreement or bias are provided.
Precision	Serum: < 20% total CV Urine: < 20% total CV	- Serum: Total CVs ranged from 2.5% to 6.2%. All reported total CVs are well below the <20% acceptance criterion. - Urine: Total CVs ranged from 3.8% to 6.4%. All reported total CVs are well below the <20% acceptance criterion.
Interferences (Endogenous Substances)	Not explicitly stated but inferred to be within acceptable clinical limits (e.g., typically ±10% or similar).	- Serum: % Interference ranged from -7.8% to +13.2%. - Urine: % Interference ranged from -4.6% to 6.1%.
Interferences (HAMA & RF)	Acceptance Criteria: 100 ± 15% Recovery (for spiked samples)	- HAMA: Grand Mean % Recovery = 100.1%, which is within 100 ± 15%. Individual % Recovery values ranged from 97.8% to 102.8%. - Rheumatoid Factor: Grand Mean % Recovery = 94.1%, which is within 100 ± 15%. Individual % Recovery values ranged from 89.7% to 102.1%.
Anticoagulants	No significant difference between serum and plasma recovery.	The summary states: "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." This confirms the acceptance criterion.
Specificity (Cross-Reactivity)	Not explicitly stated but inferred to be low values to demonstrate specificity.	Most cross-reactants showed very low % Cross Reactivity (0.0% to 2.8%). Noted exceptions were Fludrocortisone (36.8%) and Prednisolone (12.5%). The document doesn't explicitly state an acceptance criterion for cross-reactivity, but these values are reported.
Calibration Curve Stability	30 days stability.	A 30-day calibration curve stability is supported by the data.
Reagent On-Board Stability	30 days stability.	A 30-day on-board reagent stability claim is supported by the data.

2. Sample Size Used for the Test Set and Data Provenance:

Linearity: The study used a "regression analysis plot" and involved constructing "r regression and regression standard error (Reg SE)" for "each pool." The number of unique samples or data points for each dilution is not explicitly stated in the table, but it shows results for dilution range from 0% to 100% for two serum pools (65 ug/dL and 8 ug/dL). The guidance used was NCCLS guideline EP6-A. Provenance is not specified (e.g., country, retrospective/prospective).
Accuracy: Cortisol was spiked into human serum from 3 donors and human urine from 3 donors. The samples were analyzed in triplicate. Provenance is not specified.
Sensitivity:
- LoB and LoD: 60 blank samples and 120 low-level samples were used to determine LoB and LoD.
- Functional Sensitivity: Not explicitly stated, but based on CLSI guideline NCCLS EP17-A.
  Provenace of samples not specified.
Method Comparison: Patients samples were used (serum and urine). The number of samples is not provided. The study was conducted according to CLSI Guideline NCCLS EP9. Provenance not specified.
Precision:
- 80 replicates (n=80) for each of the three MCC (Multi-constituent Control) levels and three serum panel levels on both the i2000 and i2000SR instruments.
- 80 replicates (n=80) for each of the four urine panel levels on both the i2000 and i2000SR instruments.
  The study was performed using NCCLS guideline EP5-A2. Provenance not specified.
Interferences (Endogenous Substances):
- Serum: 3 replicates (N=3) for each interferent concentration and Cortisol target concentration.
- Urine: Data represents a comparison of "Unaltered Urine Control" vs. "Mock spike Control" and then individual interferents. Number of replicates not explicitly stated, but implies multiple measurements.
  The study was conducted using CLSI Guideline NCCLS EP7-A2. Provenance not specified.
Interferences (HAMA & RF):
- HAMA: 10 samples (HAMA-1, HAMA-2 and 8 other samples) were tested.
- Rheumatoid Factor (RF): 10 positive RF patient samples were assayed.
  Provenance not specified.
Specificity: Cortisol was spiked into cortisol-free human serum. Cross-reactant stock concentrates were prepared and spiked into aliquots of the 12 ug/dL cortisol serum. The total number of unique samples/aliquots is not precisely stated but involves a comprehensive list of 37 cross-reactants. Provenance not specified.
On-Board Stability: Details on the sample size used for stability studies (number of samples, replicates, etc.) are not provided in the summary. Provenance not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

The device is an in vitro diagnostic (IVD) assay for quantitative determination of cortisol. The "ground truth" for such devices is typically established through a reference method or known concentrations of analytes, not through human expert interpretation of images or clinical cases. Therefore, the concept of "experts" as in "radiologists with 10 years of experience" is not applicable here.

For studies like linearity, accuracy (recovery), sensitivity, and precision, the ground truth is based on:
- Known concentrations: For spiked samples and controls.
- Reference method values: For method comparison (in this case, the predicate device Abbott AxSYM Cortisol assay).
No information is provided about clinical expert adjudication or establishment of ground truth in the context of clinical expert review.

4. Adjudication Method for the Test Set:

Not applicable. As this is an IVD assay measuring an analyte concentration, the results are quantitative and compared against expected values, known concentrations, or results from a predicate device. There is no mention of a human expert adjudication process (e.g., 2+1, 3+1) because that process is typically associated with subjective interpretation tasks (like image review) where there can be disagreement among experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

No. An MRMC study is not relevant for this type of IVD device. MRMC studies are typically used to evaluate the impact of AI on human reader performance, for instance, in diagnostic imaging where human readers interpret cases. This submission is for a standalone laboratory assay that quantifies a biomarker.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, the studies presented (linearity, accuracy, sensitivity, precision, interferences, specificity, stability) all represent the standalone performance of the ARCHITECT Cortisol assay without human-in-the-loop assistance in the interpretation of the assay result itself. The assay directly outputs a quantitative value. The human involvement is in performing the test and reviewing the quantitative result, but not in interpreting subjective data for diagnostical decision-making.

7. The Type of Ground Truth Used:

The ground truth used for these studies includes:

Known (prepared) concentrations: For linearity panels, spiked accuracy samples (serum and urine), and sensitivity studies (blank and low-level samples).
Reference method/predicate device comparison: For method comparison, the Abbott AxSYM Cortisol assay served as the comparative "truth" or reference method to demonstrate substantial equivalence.
Defined control material values: For precision studies (MCC samples).

8. The Sample Size for the Training Set:

This information is not applicable to this type of traditional in vitro diagnostic assay. These assays are developed through chemical and biological formulation and optimization, not through machine learning models that require distinct training sets. The development process involves extensive experimentation and validation, but not in the "training set" sense of AI/ML.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable for the same reason as above. There is no "training set" in the context of machine learning for this device. The development and optimization of the assay's reagents and protocols are based on established analytical chemistry principles and performance characteristics, validated against known standards and reference materials.

Summary

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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

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

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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

	DeviceARCHITECT Cortisol	PredicateAxSYM Cortisol
IntendedUse(Reagents)	ARCHITECT Cortisol is a chemiluminescentmicroparticle immunoassay (CMIA) for thequantitative determination of cortisol inhuman serum, plasma or urine on theARCHITECT / System. The ARCHITECTCortisol assay is intended for use as an aid inthe diagnosis and treatment of adrenaldisorders.	The Cortisol assay is a FluorescencePolarization Immunoassay (FPIA) for thequantitative measurement of cortisol inhuman serum, plasma and urine on theAxSYM System to aid in the diagnosis andtreatment of adrenal disorders.
IntendedUse(Calibrators)	The ARCHITECT® Cortisol Calibrators arefor the calibration of the ARCHITECT iSystem when used for the quantitativedetermination of cortisol in human serum,plasma or urine.	The AxSYM Cortisol Calibrators are for thecalibration of the Abbott AxSYM CortisolSystem to aid in the diagnosis andtreatment of adrenal disorders.
Indicationsfor Use	The results obtained are used to aiddiagnosis and treatment of adrenal disorders.	The results obtained are used to aiddiagnosis and treatment of adrenaldisorders.
Methodology	Heterogeneous chemiluminescentmicroparticle immunoassay (CMIA).	Fluorescence Polarization Immunoassay(FPIA) technology.
ReagentComponents	Two (2) reagent system:• Microparticle Reagent with Anti-Cortisol (mouse) coated Microparticles inbuffer with protein stabilizer, Proclin 300and sodium azide.• Conjugate Reagent with Cortisolacridinium labeled conjugate in buffer withsurfactant stabilizer and Proclin 300.	Three (3) reagent system:• Pretreatment Solution (P)Surfactant in TRIS buffer and sodiumazide.• Cortisol Antiserum (Mouse andGoat) in buffer with protein stabilizerand Sodium azide.• Cortisol Fluorescein Tracer inbuffer containing surfactant andstabilizers, 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	Resultug/dL	Predicted1stug/dL	Predicted2ndug/dL	differenceug/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	Resultug/dL	Predicted1stug/dL	Predicted2ndug/dL	differenceug/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

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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
Spiked5 ug/dL	12.5	12.7	98.5	17.8	18.2	97.6	16.4	17.1	95.7
Spiked10 ug/dL	15.7	17.3	90.9	21.2	22.8	93.2	20.4	21.7	94.1
Spiked20 ug/dL	23.7	26.4	89.6	28.7	31.8	90.2	28.4	30.8	92.3
Spiked40 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
Spiked5 ug/dL	10.4	10.3	100.9	25.1	26.4	94.9	16.1	16.4	97.9
Spiked10 ug/dL	14.0	14.9	93.8	29.5	30.9	95.5	19.3	21.0	91.9
Spiked20 ug/dL	22.2	24.1	92.0	34.6	39.8	87.0	27.6	30.1	91.7
Spiked40 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

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.

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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	MeanConc.ug/dL	Within Run		Between Day		Total
					SD	%CV	SD	%CV	SD	%CV
MCC 1	I2000I2000S	AB	80	3.84.0	0.13690.1924	3.64.8	0.13150.0000	3.40.0	0.18980.2321	5.05.8
MCC 2	I2000I2000S	AB	80	16.617.3	0.43000.4000	2.62.3	0.40710.5459	2.53.2	0.61841.3228	3.77.7
MCC 3	I2000I2000S	AB	80	30.331.0	0.87390.6344	2.92.1	0.67841.1223	2.23.6	1.16951.3178	3.94.3
Serum panel 1	I2000I2000S	AB	80	2.92.9	0.08290.1601	2.95.5	0.00000.0835	0.02.9	0.11400.1806	4.06.2
Serum panel 2	I2000I2000S	AB	80	39.841.0	0.95261.0822	2.42.6	0.00000.4470	0.01.2	1.00651.2947	2.53.2
Serum panel 3	I2000I2000S	AB	80	53.355.8	1.70611.5047	3.22.7	0.28870.9540	0.51.7	1.73031.8730	3.33.4
Urine panel 1	I2000I2000S	AB	80	2.42.7	0.12700.1636	5.36.1	0.05450.0463	2.31.7	0.14820.1700	6.26.4
Urine panel 2	I2000I2000S	AB	80	14.515.9	0.39270.6039	2.73.8	0.00000.3916	0.02.5	0.58750.7198	4.14.5
Urine panel 3	I2000I2000S	AB	80	36.840.6	1.05091.5605	2.93.9	0.57420.3012	1.60.7	1.39161.5893	3.83.9
Urine panel 4	I2000I2000S	AB	80	49.053.7	2.84023.1812	5.85.9	0.00000.0000	0.00.0	2.84023.1812	5.85.9

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

InterferingSubstance	InterferentConcentration	N	Targetµg/mL	Mean Recoveryµg/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	Concentrationof Interferant	MeanRecoveryEndogenousCortisol only	%Interference	MeanRecoveryCortisolSpiked	%Interference
UnalteredUrine Control	N/A	4.9	N/A	36.9	N/A
Mockspike 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 Cortisolug/dL	Spiked withCortisol ug/dL	Spiked withcortisol-freeserum 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 Criteria100±15%		100.1

C. Rheumatoid Factor (RF)

Ten positive RF patient samples were assayed for cortisol concentration.

Sample	NativeCortisolug/dL	Spiked Cortisolug/dL	Spiked withcortisol-freeserum 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 Criteria100±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 concug/dL	% CrossReactivity	Cross Reactant	Test concug/dL	% CrossReactivity
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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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)

Division Sign-Off	for Carol Benson
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Office of In Vitro Diagnostic Device
Evaluation and Safety... 127622-0-1

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.