Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard chemiluminescent immunoassay kit and its performance characteristics, with no mention of AI or ML in the intended use, device description, or performance studies.

Therapeutic

No
This device is an in vitro diagnostic (IVD) immunoassay designed for the quantitative determination of testosterone levels, which is used for diagnosis and monitoring of medical conditions, not for therapeutic intervention.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that "Measurements of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens)..." This directly indicates its role in diagnosis.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components including reagent kits, microparticles, conjugate, diluents, calibrators, and controls, which are all tangible chemical substances and materials, not software.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use explicitly states the quantitative determination of testosterone in human serum and plasma for the diagnosis and treatment of various disorders. This aligns directly with the definition of an in vitro diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
Device Description: The device consists of reagents (microparticles, conjugate, diluents) and calibrators and controls, which are typical components of an in vitro diagnostic assay kit used to perform tests on biological samples.
Performance Studies: The document describes performance studies such as precision, sensitivity, linearity, interference, and method comparison, which are standard evaluations for IVD devices to demonstrate their analytical performance.
Predicate Device: The mention of a predicate device (Roche Elecsys Testosterone II assay) with a K number (K093421) indicates that this device is being compared to a previously cleared IVD device, a common practice in the regulatory pathway for IVDs.

All these elements strongly indicate that the ARCHITECT 2nd Generation Testosterone assay is an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The ARCHITECT 2nd Generation Testosterone assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of testosterone in human serum and plasma. Measurements of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females, hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.

The ARCHITECT 2nd Generation Testosterone Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of testosterone in human serum and plasma.

The ARCHITECT 2nd Generation Testosterone Controls are for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of testosterone in human serum and plasma.

Product codes (comma separated list FDA assigned to the subject device)

CDZ, JIT, JJX

Device Description

The ARCHITECT 2nd Generation Testosterone Reagent Kit consists of 100 (1 x 100) or 400 (4 x 100) tests. Each kit contains 1 or 4 bottle(s) each of Microparticles. Conjugate. Assay Specific Diluent, and Specimen Diluent.

Microparticles 1 or 4 Bottle(s) (6.6 mL) Anti-Testosterone (sheep, monoclonal) coated . microparticles in BIS Tris buffer with protein (bovine) stabilizer. Minimum concentration: 0.1% solids. Preservative: ProClin 300.
. Conjugate -1 or 4 Bottle(s) (6.9 mL) Testosterone acridinium-labeled conjugate in BIS Tris buffer with surfactant stabilizer. Minimum concentration: 6.5 nmol/L. Preservative: ProClin 300.
. Assay Specific Diluent - 1 or 4 Bottle(s) (25.0 mL) Testosterone Assay Diluent containing phosphate and glycine in citrate buffer. Preservative: ProClin 300.
. Specimen Diluent - 1 or 4 Bottle(s) (12.2 mL) Testosterone Specimen Diluent containing PBS buffer. Preservative: ProClin 300.

Each ARCHITECT 2nd Generation Testosterone Calibrator Kit contains 6 Bottles (4.0 mL each) of ARCHITECT 2nd Generation Testosterone Calibrators A-F. Calibrator A contains PBS buffer. Calibrators B through F contain testosterone in PBS buffer. All calibrators contain a protein (bovine) stabilizer. Preservative: ProClin 300.

Each ARCHITECT 2nd Generation Testosterone Control Kit contains 3 Bottles (8.0 mL each) of ARCHITECT 2nd Generation Testosterone Controls. The Low, Medium, and High Controls contain testosterone in PBS buffer with a protein (bovine) stabilizer. Preservative: ProClin 300.

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

Measurements of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females, hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes. Patient age range not explicitly defined, but conditions imply applicability across various ages.

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)

Precision:
A within-laboratory precision study was performed based on guidance from the National Committee for Clinical Laboratory Standards (NCCLS) document EP5-A2.
Sample Size: 80 replicates for each control level and panel across two instruments and two reagent lots.
Key results: Within-laboratory (total) imprecision was within the designed ≤ 10% CV for samples with testosterone concentrations ≥ 14.4 ng/dL to 1009 ng/dL.

Sensitivity:
Limit of Quantitation (LoQ) study based on NCCLS document EP17-A.
Observed LoQ: 4.33 ng/dL with an inter-assay CV of 15.6%.
Limit of Blank (LoB): 1.73 ng/dL.
Limit of Detection (LoD): 2.67 ng/dL.

Measuring Interval (Reportable Range):
Defined as 4.33 ng/dL (LoQ) to 1500.00 ng/dL.

Linearity:
A study was performed based on NCCLS document EP6-A.
Linear range: 3.82 - 1862.27 ng/dL, supporting the Measuring Interval of 4.33 ng/dL to 1500 ng/dL.

Interference:
Potentially Interfering Endogenous Substances: Evaluated based on CLSI protocol EP7-A2. Interference from bilirubin, hemoglobin, total protein, triglycerides, biotin, and Sex Hormone Binding Globulin (SHBG) was determined to be = 50 years): 127.18 - 1020.36 ng/dL
Females (21-49 years): 7.21 - 79.31 ng/dL
Females (>= 50 years): 8.65 - 36.92 ng/dL

Method Comparison:
Comparison to Liquid Chromatography - Tandem Mass Spectrometry (LCMS) based on CLSI document EP9-A2-IR using the Passing-Bablok regression method.
Sample Size: n = 138 (total), n = 73 (female specimens), n = 65 (male specimens).
Key results:
Overall (n=138): Correlation Coefficient (r) = 0.994, Slope = 1.00, Intercept = -3.70.
Female Specimens (n=73): Correlation Coefficient (r) = 0.985, Slope = 0.82, Intercept = 2.77.
Male Specimens (n=65): Correlation Coefficient (r) = 0.990, Slope = 1.10, Intercept = -48.63.
The assay is designed to have a slope of 1.0 +/- 0.2 and a correlation coefficient (r) of >= 0.95.

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

Within-laboratory (total) imprecision: = 0.95

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K093421

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 862.1680 Testosterone test system.

(a)
Identification. A testosterone test system is a device intended to measure testosterone (a male sex hormone) in serum, plasma, and urine. Measurement of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.(b)
Classification. Class I.

Summary

0

K12009

SEP

1 1 2012

510(k) Summary (Summary of Safety and Effectiveness)

This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

1. Applicant Name

John Rizos, Regulatory Affairs Project Manager Regulatory Affairs Abbott Laboratories Diagnostics Division Dept 9V6, AP5N-2 100 Abbott Park Road Abbott Park, IL 60064 Telephone Number: (847) 935-1813 Fax Number: (847) 937-4836 Date Summary prepared: September 7, 2012

2. Device Name

ARCHITECT 2nd Generation Testosterone ARCHITECT 2nd Generation Testosterone Calibrators ARCHITECT 2nd Generation Testosterone Controls

Reagents

Classification Name: Testosterone test system Trade Name: ARCHITECT 2nd Generation Testosterone Common Name: Testosterone Governing Regulation: 862.1680 Device Classification: Class I, reserved Classification Panel: Clinical Chemistry Product Code: CDZ

Calibrators

Classification Name: Calibrator Trade Name: ARCHITECT 2nd Generation Testosterone Calibrators Common Name: Calibrator Governing Regulation: 862.1150 Device Classification: Class II Classification Panel: Clinical Chemistry Product Code: JIT

1

Controls

Classification Name: Quality Control Material (assayed and unassayed) Trade Name: ARCHITECT 2nd Generation Testosterone Controls Common Name: Control Governing Regulation: 862.1660 Device Classification: Class I , reserved Classification Panel: Clinical Chemistry Product Code: JJX

3. Predicate Device

Roche Elecsys Testosterone II assay (K093421)

4. Intended Use of Device

The ARCHITECT 2nd Generation Testosterone assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of testosterone in human serum and plasma. Measurements of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females, hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.

The ARCHITECT 2nd Generation Testosterone Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of testosterone in human serum and plasma.

The ARCHITECT 2nd Generation Testosterone Controls are for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of testosterone in human serum and plasma.

5. Description of Device

ARCHITECT 2nd Generation Testosterone Reagents

The ARCHITECT 2nd Generation Testosterone Reagent Kit consists of 100 (1 x 100) or 400 (4 x 100) tests. Each kit contains 1 or 4 bottle(s) each of Microparticles. Conjugate. Assay Specific Diluent, and Specimen Diluent.

2

Microparticles 1 or 4 Bottle(s) (6.6 mL) Anti-Testosterone (sheep, monoclonal) coated . microparticles in BIS Tris buffer with protein (bovine) stabilizer. Minimum concentration: 0.1% solids. Preservative: ProClin 300.
. Conjugate -1 or 4 Bottle(s) (6.9 mL) Testosterone acridinium-labeled conjugate in BIS Tris buffer with surfactant stabilizer. Minimum concentration: 6.5 nmol/L. Preservative: ProClin 300.
. Assay Specific Diluent - 1 or 4 Bottle(s) (25.0 mL) Testosterone Assay Diluent containing phosphate and glycine in citrate buffer. Preservative: ProClin 300.
. Specimen Diluent - 1 or 4 Bottle(s) (12.2 mL) Testosterone Specimen Diluent containing PBS buffer. Preservative: ProClin 300.

ARCHITECT 2nd Generation Testosterone Calibrators

Each ARCHITECT 2nd Generation Testosterone Calibrator Kit contains 6 Bottles (4.0 mL each) of ARCHITECT 2nd Generation Testosterone Calibrators A-F. Calibrator A contains PBS buffer. Calibrators B through F contain testosterone in PBS buffer. All calibrators contain a protein (bovine) stabilizer. Preservative: ProClin 300.

	Concentration
Calibrator	nmol/L	ng/dL	ng/mL
Cal A	0.00	0.00	0.00
Cal B	0.10	2.88	0.03
Cal C	0.20	5.77	0.06
Cal D	1.60	46.14	0.46
Cal E	12.50	360.50	3.60
Cal F	30.00	865.20	8.64

The calibrators are manufactured at the following concentrations:

ARCHITECT 2nd Generation Testosterone Controls

Each ARCHITECT 2nd Generation Testosterone Control Kit contains 3 Bottles (8.0 mL each) of ARCHITECT 2nd Generation Testosterone Controls. The Low, Medium, and High Controls contain testosterone in PBS buffer with a protein (bovine) stabilizer. Preservative: ProClin 300.

3

Control	Target Concentration / Range
	nmol/L	ng/dL	ng/mL
Control L	0.31
0.16 - 0.46	8.94
4.61 - 13.27	0.09
0.05 - 0.13
Control M	2.42
1.52 - 3.32	69.79
43.62 - 95.96	0.70
0.44 - 0.96
Control H	7.58
4.74 - 10.42	218.61
136.63 - 300.59	2.18
1.37 - 2.99

The controls are at the following concentrations:

6. Comparison of Technological Characteristics

The ARCHITECT 2nd Generation Testosterone assay utilizes chemiluminescent microparticle immunoassay (CMIA) technology for the quantitative determination of testosterone in human serum and plasma. The Roche Elecsys Testosterone II assay utilizes electrochemiluminescence immunoassay technology ("ECLIA") and is intended for use on Elecsys and cobas e immunoassay analyzers.

Reagent Kit Similarities and Differences
Characteristics	Submission Device
ARCHITECT 2nd
Generation Testosterone	Predicate Device
Roche Elecsys
Testosterone II (K093421)
Intended Use and
Indications for Use	Immunoassay for the in vitro
quantitative determination of
testosterone in human serum
and plasma.
Measurements of testosterone
are used in the diagnosis and
treatment of disorders
involving the male sex
hormones (androgens),
including primary and
secondary hypogonadism,
delayed or precocious
puberty, impotence in males
and, in females, hirsutism
(excessive hair) and
virilization (masculinization)
due to tumors, polycystic
ovaries, and adrenogenital
syndromes.	Same
Reagent Kit Similarities and Differences
Characteristics	Submission Device
ARCHITECT 2nd
Generation Testosterone	Predicate Device
Roche Elecsys
Testosterone II (K093421)
Platform	ARCHITECT i System
(immunoassay analyzer)	Elecsys and cobas e
immunoassay analyzers
Methodology	Chemiluminescence
(CMIA)	Electrochemiluminescence
(ECLIA)
Specimen type	Serum and plasma	Serum and plasma
Expected Values	• Males (21-49) :
47.01 - 980.56 ng/dL
• Males (≥ 50 years of age):
127.18-1020.36 ng/dL
• Females (21-49):
7.21-79.31 ng/dL
• Females (≥ 50 years of age):
8.65-36.92 ng/dL	• Males (20-49):
249 - 836 ng/dL
• Males (≥ 50):
193 - 740 ng/dL
• Females (20-49):
8.40 - 48.1 ng/dL
• Females (≥ 50):
2.90 - 40.8 ng/dL
In addition, a reference range
study using pediatric
population (95 males and 100
females) under 18 years old,
who were in good
endocrinological health was
performed.
Measuring Interval	Measuring interval is defined
as the range of values in
ng/dL (nmol/L) which meets
the acceptable performance
for both imprecision and bias
across all available assay file
dilutions. The range was
4.33 ng/dL (0.15 nmol/L)
(Limit of Quantitation - LoQ)
to 1500.00 ng/dL
(52.01 nmol/L).	Measuring Range:
2.50 - 1500 ng/dL or
0.087 - 52.0 nmol/L
(defined by the limit of
detection and the maximum
of the master curve). Values
below the limit of detection
are reported as 1500 ng/dL or >
52.0 nmol/L
LoB	LoB: 1.73 ng/dL (0.06
nmol/L)	LoB: 1.20 ng/dL or 0.42
nmol/L
LoD
Reagent Kit Similarities and Differences
	Submission Device
ARCHITECT 2nd
Generation Testosterone	Predicate Device
Roche Elecsys
Testosterone II (K093421)
Characteristics
LoQ	LoD: 2.67 ng/dL (0.10 nmol/L)
LoQ: 4.33 ng/dL (0.15 nmol/L)	LoD: 2.50 ng/dL or 0.087 nmol/L
LoQ: 12.0 ng/dL or 0.416 nmol/L
Components:
1	Microparticles:
1 or 4 Bottle(s) (6.6 mL)
Anti-Testosterone (sheep, monoclonal) coated
microparticles in BIS Tris buffer with protein (bovine) stabilizer. Minimum
concentration: 0.1% solids.
Preservative: ProClin 300.	M:
Streptavidin-coated microparticles (transparent cap), 1 bottle, 6.5mL:
Streptavidin-coated microparticles 0.72 mg/mL,
preservative.
2	Conjugate: 1 or 4 Bottle(s) (6.9 mL) Testosterone
acridinium-labeled conjugate in BIS Tris buffer with
surfactant stabilizer.
Minimum concentration: 6.5 nmol/L. Preservative:
ProClin 300.	R1:
Anti-testosterone-Ab ${\sim}$ biotin (gray cap), 1 bottle, 10mL:
Biotinylated monoclonal anti-testosterone antibody (sheep) 40 ng/mL; releasing reagent
2-bromoestradiol; MES buffer 50 mmol/L, pH 6.0;
preservative.
3	Assay Specific Diluent:
1 or 4 Bottle(s) (25.0 mL)
Testosterone Assay Diluent containing phosphate and
glycine in citrate buffer.
Preservative: ProClin 300.	R2:
Testosterone-peptide
${\sim}$ Ru(bpy)5+ (black cap), 1
bottle, 9 mL: Testosterone derivative, labeled with
ruthenium complex 1.5
ng/mL; MES buffer 50
mmol/L, pH 6.0; preservative.
4	Specimen Diluent:
1 or 4 Bottle(s) (12.2 mL)
Testosterone Specimen
Diluent containing PBS
buffer. Preservative:
ProClin 300	NA

4

.

·

5

.

6

Calibrators: Similarities and Differences:
Characteristics	Submission Device
ARCHITECT 2nd
Generation Testosterone	Predicate Device ·
Roche Elecsys
Testosterone II (K093421)
Intended use	The ARCHITECT 2nd
Generation Testosterone
Calibrators are for the
calibration of the
ARCHITECT i System when
used for the quantitative
determination of testosterone
in human serum and plasma.	The Elecsys Testosterone
CalSetII is intended for the
calibration of the quantitative
testosterone assay on the
Elecsys immunoassay
analyzer systems.
Levels	6 levels	The calibration curve is
instrument-specifically
generated by 2-point
calibration and a master curve
provided via the reagent
barcode. Testosterone II
CalSet II -2 levels.

	nmol/Lng/dLng/mLA0.000.000.00B0.102.880.03C0.205.770.06D1.6046.140.46E12.50360.503.60F30.00865.208.64



	Components	6 Bottles (4.0 mL each) of
ARCHITECT 2nd
Generation Testosterone
Calibrators A-F. Calibrator A
contains PBS buffer.
Calibrators B through F
contain testosterone in PBS
buffer. All calibrators contain
a protein (bovine) stabilizer.
Preservative: ProClin 300.	Lyophilized human serum
with 2 testosterone
concentration levels
Standardization/
Traceability	Abbott manufactures internal
reference standards for
ARCHITECT 2nd
Generation Testosterone
using Testosterone Reference
Standard (USP).
Testosterone calibrators are
manufactured gravimetrically
and tested against these
internal reference standards.	This method has been
standardized via ID-GC/MS
(Isotope Dilution-Gas
Chromatography/Mass
Spectrometry).

. .

.

7

Controls: Similarities and Differences:
Characteristics	Submission Device
ARCHITECT 2nd
Generation Testosterone	Predicate Device
Roche Elecsys
Testosterone II (K093421)
Intended use	The ARCHITECT 2nd
Generation Testosterone
Controls are for the
verification of the accuracy
and precision of the
ARCHITECT i System when
used for the quantitative
determination of testosterone
in human serum and plasma.	The Elecsys PreciControl
Universal 1 and 2, are used
for monitoring the accuracy
and precision of Elecsys
immunoassays.
Matrix and
Components	3 Bottles (8.0 mL each) of
ARCHITECT 2nd
Generation Testosterone
Controls. Low, Medium, and
High Controls contain
testosterone in PBS buffer
with a protein (bovine)
stabilizer. Preservative:
ProClin 300.	Lyophilized control serum
based on human serum
Levels	3 levels: Low. Medium, and
High
Targets:


	nmol/L ng/dL ng/mL L 0.31 8.94 0.09 M 2.42 69.79 0.70 H 7.58 218.61 2.18

:

.

:

·

8

7. Summary of Nonclinical Performance

SPECIFIC PERFORMANCE CHARACTERISTICS

Precision

The ARCHITECT 2nd Generation Testosterone assay is designed to have a within-laboratory (total) imprecision of ≤ 10% CV for samples with testosterone concentrations ≥ 14.4 ng/dL to 1009 ng/dL.

Within-Laboratory Precision

A study was performed based on guidance from the National Committee for Clinical Laboratory Standards (NCCLS) document EP5-A2. Testing was conducted using two instruments, two ARCHITECT 2nd Generation Testosterone Reagent Kit lots, and one lot each of ARCHITECT 2nd Generation Testosterone Calibrators and Controls. Three levels of controls and 1 human serum panel were assayed with a minimum of 2 replicates at 2 separate times per day for 20 different days. The data are summarized in the following table.

Sample	Instrument	Reagent Lot	n	Mean ng/dL	Within Run		Within - Laboratory (Total)
					SD	%CV	SD	%CV
Control Level 1	1	1	80	9.88	0.456	4.6	0.477	4.8
		2	80	9.24	0.358	3.9	0.472	5.1
	2	1	80	9.56	0.390	4.1	0.439	4.6
		2	80	9.02	0.459	5.1	0.468	5.2
Control Level 2	1	1	80	76.07	2.339	3.1	2.734	3.6
		2	80	72.07	2.277	3.2	2.361	3.3
	2	1	80	74.24	2.492	3.4	2.661	3.6
		2	80	72.86	1.769	2.4	2.684	3.7
Control Level 3	1	1	80	228.38	4.811	2.1	5.993	2.6
		2	80	226.67	4.643	2.0	6.008	2.7
	2	1	80	227.22	5.732	2.5	7.496	3.3
		2	80	229.95	5.504	2.4	6.391	2.8
Panel	1	1	80	62.35	2.287	3.7	2.379	3.8
		2	80	60.72	1.285	2.1	1.796	3.0
	2	1	80	61.30	1.888	3.1	2.184	3.6
		2	80	61.53	1.558	2.5	2.028	3.3

9

Sensitivitv

Limit of Quantitation

The ARCHITECT 2nd Generation Testosterone assay is designed to have a Limit of Quantitation (LoQ) of ≤ 4.33 ng/dL. The LoQ is defined as the lowest analyte concentration that meets an inter-assay imprecision of 14.4 ng/dL, a linear range of 3.82 - 1862.27 ng/dL was demonstrated for the ARCHITECT 2nd Generation Testosterone assay which supports the Measuring Interval (Reportable Range) of 4.33 ng/dL to 1500 ng/dL.

Interference

Potentially Interfering Endogenous Substances

Potential interference in the ARCHITECT 2nd Generation Testosterone assay from billirubin. hemoglobin, total protein, triglycerides, biotin, and Sex Hormone Binding Globulin (SHBG) was evaluated to be 50 years of age). The data are summarized in the following table.

| Category
Apparently Healthy | n | Age
Range
(years) | Median | Min. | Max. | 5th
percentile | 95th
percentile |
|---------------------------------------|-----|-------------------------|--------|--------|---------|-------------------|--------------------|
| Males
(21-49 years of age) | 129 | 21-49 | 494.03 | 47.01 | 980.56 | 240.24 | 870.68 |
| Males
($\geq$ 50 years of age) | 71 | 50-77 | 442.41 | 127.18 | 1020.36 | 220.91 | 715.81 |
| Females
(21-49 years of age) | 129 | 21-49 | 24.80 | 7.21 | 79.31 | 13.84 | 53.35 |
| Females
($\geq$ 50 years of age) | 52 | 50-82 | 23.50 | 8.65 | 36.92 | 12.40 | 35.76 |

Method Comparison

The ARCHITECT 2nd Generation Testosterone assay is designed to have a slope of 1.0 ± 0.2 and a correlation coefficient (r) of ≥ 0.95 for samples with testosterone concentrations ranging from 4.33 ng/dL (LoQ) to 1500.00 ng/dL when compared to Liquid Chromatography - Tandem Mass Spectrometry (LCMS). A method comparison study was performed based on guidance from the CLSI document EP9-A2-IR using the Passing-Bablok regression method to compare the ARCHITECT 2nd Generation Testosterone assay to the LCMS testosterone method. The data are summarized in the following tables.

ARCHITECT 2nd Generation Testosterone vs. LCMS

(n = 138)

| Concentration Range
ng/dL | | Correlation
Coefficient
(r) | Intercept
ng/dL | 95%
CIa | Slope | 95%
CIa |
|------------------------------|-------------|-----------------------------------|--------------------|----------------|-------|--------------|
| ARCHITECT | LCMS | | | | | |
| 13.74-1429.61 | 6.0-1330.00 | 0.994 | -3.70 | (-5.00, -1.66) | 1.00 | (0.98, 1.03) |

a CI = Confidence Interval

13

ARCHITECT 2nd Generation Testosterone vs. LCMS

| Concentration Range
ng/dL | | Correlation
Coefficient
(r) | Intercept
ng/dL | 95%
CIa | Slope | 95%
CIa |
|------------------------------|-----------|-----------------------------------|--------------------|--------------|-------|--------------|
| ARCHITECT | LCMS | | | | | |
| 13.74-349.97 | 6.0-346.5 | 0.985 | 2.77 | (0.53, 4.45) | 0.82 | (0.77, 0.88) |

Female Specimens (n = 73)

ª CI = Confidence Interval

ARCHITECT 2nd Generation Testosterone vs. LCMS

Male Specimens (n = 65)

| Concentration Range
ng/dL | | Correlation
Coefficient
(r) | Intercept
ng/dL | 95%
CIa | Slope | 95%
CIa |
|------------------------------|--------------|-----------------------------------|--------------------|------------------|-------|--------------|
| ARCHITECT | LCMS | 0.990 | -48.63 | (-62.25, -32.25) | 1.10 | (1.07, 1.13) |
| 86.93-1429.61 | 115.0-1330.0 | | | | | |

4 CI = Confidence Interval

8. Conclusion

The data presented in this premarket notification demonstrates that the ARCHITECT 2nd Generation Testosterone assay performs substantially equivalent to the predicate device, the Roche Elecsys Testosterone II assay (K093421). Accuracy was demonstrated by comparison to a Liquid Chromatography - Tandem Mass Spectrometry (LCMS) reference method. The data presented in the premarket notification provide reasonable assurance that the ARCHITECT 2nd Generation Testosterone assay is safe and effective for the stated intended use.

14

10903 New Hampshire Avenue Silver Spring, MD 20993

Abbott Laboratories Abbott Laboratories Diagnostics Division c/o John Rizos Dept 9V6, AP5N-2 100 Abbott Park Road Abbott Park, IL 60064

7 1 2012

K120009 Re:

Trade Name: ARCHITECT 2nd Generation Testosterone ARCHITECT 2nd Generation Testosterone Calibrators ARCHITECT 2nd Generation Testosterone Controls Regulation Number: 21 CFR §862.1680 Regulation Name: Testosterone Test System Regulatory Class: Class I, reserved Product Codes: CDZ, JIT, JJX Dated: July 27, 2012 Received: July 30, 2012

Dear Mr. Rizos:

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 (1 writ), it may of babyest to Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. four device can be four learning 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 moun mat FDP may Federal statutes and regulations administered by other Federal agencies. of the recordly 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 and fishing (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).

Image /page/14/Picture/11 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of a stylized eagle.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice tor your as now in as absation 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 CFK Parl 807.97). For questions regarding positions of Postmarket Surveillance at (301).
Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveilliance a Office of Surveinations regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

CFK Part 803), prease go to intp://www.htmlgor.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 Tou thay of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address (000) 030-2641 or (504) MedicalDevices/Resourcesfor You/Industry/default.htm

Sincerely yours,

Courtney H. Lias, Ph.D.

Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K120009 Device Name: ARCHITECT 2nd Generation Testosterone ARCHITECT 2nd Generation.Testosterone Calibrators ARCHITECT 2nd Generation Testosterone Controls

Indications for Use:

The ARCHITECT 2nd Generation Testosterone assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of testosterone in human serum and plasma. Measurements of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females, hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.

The ARCHITECT 2nd Generation Testosterone Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of testosterone in human serum and plasma.

The ARCHITECT 2nd Generation Testosterone Controls are for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of testosterone in human serum and plasma.

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 Device Evaluation and Safety (OIVD)

Yung Chan

Division Sign Off Office of In Vitro Diagnostic Device Evaluation and Safety