K Number

Device Name

ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH

Manufacturer

ROCHE DIAGNOSTICS CORP.

Date Cleared

2006-05-03

(57 days)

Product Code

CKG JIT JJX

Regulation Number

862.1025

Intended Use

Elecsys ACTH Assay: Immunoassay for the in vitro quantitative determination of adrenocorticotropic hormone (ACTH) in human EDTA plasma. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys 1010/2010 and MODULAR ANALYTICS E 170 (Elecsys module) immunoassay analyzers. ACTH measurements are used in the differential diagnosis and treatment of certain disorders of the adrenal glands such as Cushings syndrome, adrenocortical insufficiency, and the ectopic ACTH syndrome. Elecsys ACTH CalSet is used for calibrating the quantitative Elecsys ACTH assay on the Elecsys immunoassay analyzers. Elecsys ACTH CalCheck: For use in the verification of the calibration established by the Elecsys ACTH reagent on Elecsys 1010/2010 and MODULAR E170 immunoassay analyzers. Elecsys PreciControl ACTH is used for quality control of the Elecsys ACTH immunoassay on the Elecsys immunoassay analyzers.

Device Description

(1) The Elecsys ACTH Assay is a two step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve provided with the reagent bar code. (2) The Elecsys ACTH CalSet is a lyophilized product consisting of equine serum with added ACTH in two concentration range. During manufacture, the analyte is spiked into the matrix at the desired concentration levels. (3) The Elecsys ACTH CalCheck is a lyophilized product consisting of buffered equine serum with added ACTH. During manufacture, the analyte is spiked into the matrix at the desired concentration levels. (4) The Elecsys PreciControl ACTH is a lyophilized product consisting of equine serum with added ACTH in two concentration ranges. During manufacture, the analyte is spiked into the matrix at the desired concentration levels. Note: The reagent, calibrator, calibration verification material and the quality control are all packaged separately.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K960066, K053059, K031990

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard immunoassay and associated reagents/controls. There is no mention of AI or ML in the intended use, device description, or performance summaries. The analysis relies on a calibration curve and master curve, which are standard laboratory techniques, not AI/ML.

Therapeutic

No.
This device is an immunoassay for the quantitative determination of ACTH, used for diagnostic purposes in assessing adrenal gland disorders, not for treating them.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that "ACTH measurements are used in the differential diagnosis and treatment of certain disorders of the adrenal glands". This indicates that the device aids in the identification and distinction of medical conditions, which is the definition of a diagnostic device.

SaMD (Software as a Medical Device)

The device description clearly outlines physical components including reagents, calibrators, and controls, which are lyophilized products consisting of equine serum with added ACTH. These are not software-only components. The device also relies on specific immunoassay analyzers (Roche Elecsys 1010/2010 and MODULAR ANALYTICS E 170), which are hardware.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The "Intended Use / Indications for Use" section explicitly states: "Immunoassay for the in vitro quantitative determination of adrenocorticotropic hormone (ACTH) in human EDTA plasma." The phrase "in vitro" is a key indicator of an IVD.
Sample Type: The assay is performed on "human EDTA plasma," which is a biological sample taken from the body, a common characteristic of IVDs.
Purpose: The ACTH measurements are used in the "differential diagnosis and treatment of certain disorders," indicating a medical purpose for the test results.
Device Description: The description details an "immunoassay" and the use of "reagent, calibrator, calibration verification material and the quality control," all components typically associated with IVD test kits.
Predicate Devices: The listed predicate devices (Immulite ACTH assay, Elecsys Prolactin II CalCheck, Elecsys PreciControl Troponin T) are also IVDs, suggesting that the current device falls into the same category.

Therefore, based on the provided information, the Elecsys ACTH Assay and its associated components (CalSet, CalCheck, PreciControl) are clearly intended for in vitro diagnostic use.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

(1) Elecsys ACTH Reagent: Immunoassay for the in vitro quantitative determination of adrenocorticotropic hormone (ACTH) in human EDTA plasma. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys 1010/2010 and MODULAR ANALYTICS E 170 (Elecsys module) immunoassay analyzers. ACTH measurements are used in the differential diagnosis and treatment of certain disorders of the adrenal glands such as Cushings syndrome, adrenocortical insufficiency, and the ectopic ACTH syndrome.
(2) Elecsys ACTH CalSet is used for calibrating the quantitative Elecsys ACTH assay on the Elecsys immunoassay analyzers.
(3) Elecsys ACTH CalCheck: For use in the verification of the calibration established by the Elecsys ACTH reagent on Elecsys 1010/2010 and MODULAR E170 immunoassay analyzers.
(4) Elesys PreciControl ACTH is used for quality control of the Elecsys ACTH immunoassay on the Elecsys immunoassay analyzers.

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

CKG, JIT, JJX

Device Description

(1) The Elecsys ACTH Assay is a two step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve provided with the reagent bar code.
(2) The Elecsys ACTH CalSet is a lyophilized product consisting of equine serum with added ACTH in two concentration range. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
(3) The Elecsys ACTH CalCheck is a lyophilized product consisting of buffered equine serum with added ACTH. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
(4) The Elecsys PreciControl ACTH is a lyophilized product consisting of equine serum with added ACTH in two concentration ranges. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
Note: The reagent, calibrator, calibration verification material and the quality control are all packaged separately.

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)

Precision:
Elecsys 1010/2010:
Within-run
2.9% CV @ 4.9 pg/mL
2.0% CV @ 74.2 pg/mL
2.1% CV @ 1,390 pg/mL
1.5% CV @ 115 pg/mL
1.6% CV @ 970 pg/mL

Total
5.4% CV @ 4.9 pg/mL
2.4% CV @ 74.2 pg/mL
2.6% CV @ 1,390 pg/mL
1.7% CV @ 115 pg/mL
1.8% CV @ 970 pg/mL

E170:
Within-run
2.7% CV @ 4.9 pg/mL
0.6% CV @ 64.3 pg/mL
0.7% CV @ 1,205 pg/mL
0.6% CV @ 111 pg/mL
1.2% CV @ 968 pg/mL

Total
5.4% CV @ 4.96 pg/mL
3.5% CV @ 76.1 pg/mL
3.7% CV @ 1,444 pg/mL
1.8% CV @ 114 pg/mL
2.0% CV @ 972 pg/mL

Method Comparison (Linear Regression):
Elecsys ACTH (y) versus a commercially available ACTH test (x):
y= 0.90x + 8.17, r = 0.992, n=180

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

Analytical sensitivity (LDL): 1.0 pg/mL
Measuring Range: 1 - 2,000 pg/mL
Analytical Specificity: No cross reactivity for: ACTH (1-10), ACTH (11-24), Beta MSH, Beta Endorphin.
ACTH fragments: (ACTH 1-17, ACTH 1-24, ACTH CLIP 18-39, ACTH 22-39, Alpha MSH 1-13) > 5,000 pg/mL can bind to one of the antibodies and thereby negatively interfere with the sandwich formation and lead to lower ACTH values. Under ACTH (1-24) medication, ACTH measurement is not recommended. POMC (partially purified from an adenoma cell line) showed an approximate 1.6% cross-reactivity at 1,560 pmol/L which is approximately forty times the physiological concentration of ACTH precursors in circulation.
Hook Effect: No high dose hook effect up to 1,000,000 pg/mL.

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.

K960066, K053059, K031990

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

§ 862.1025 Adrenocorticotropic hormone (ACTH) test system.

(a)
Identification. An adrenocorticotropic hormone (ACTH) test system is a device intended to measure adrenocorticotropic hormone in plasma and serum. ACTH measurements are used in the differential diagnosis and treatment of certain disorders of the adrenal glands such as Cushing's syndrome, adrenocortical insufficiency, and the ectopic ACTH syndrome.(b)
Classification. Class II.

Summary

MAY 3 2006

Confidential

510(k) Summary	K 06058
Introduction	According to the requirements of 21 CFR 807.92, the following information
provides sufficient detail to understand the basis for a determination of
substantial equivalence.
Submitter
name, address,
contact	Roche Diagnostics
9115 Hague Road
Indianapolis, IN 46250
(317)-521-3532

Contact person: Randy J. Johnson
Date Prepared: March 6, 2006 |
| Device Name | Proprietary name: (1) Elecsys ACTH Immunoassay
(2) Elecsys ACTH CalSet
(3) Elecsys ACTH CalCheck
(4) Elecsys PreciControl ACTH

Common name: (1) ACTH Assay
(2) ACTH CalSet
(3) ACTH CalCheck
(4) PreciControl ACTH

Classification name: (1) System, Test, ACTH
(2) Calibrator, Secondary
(3 & 4) Single (specified) analyte controls (assayed and
unassayed) |

| Device
Description | (1) The Elecsys ACTH Assay is a two step sandwich immunoassay with
streptavidin microparticles and electrochemiluminescence detection. Results
are determined using a calibration curve that is generated specifically on each
instrument by a 2 point calibration and a master curve provided with the
reagent bar code.
(2) The Elecsys ACTH CalSet is a lyophilized product consisting of equine
serum with added ACTH in two concentration range. During manufacture,
the analyte is spiked into the matrix at the desired concentration levels.
(3) The Elecsys ACTH CalCheck is a lyophilized product consisting of
buffered equine serum with added ACTH. During manufacture, the analyte is
spiked into the matrix at the desired concentration levels.
(4) The Elecsys PreciControl ACTH is a lyophilized product consisting of
equine serum with added ACTH in two concentration ranges. During
manufacture, the analyte is spiked into the matrix at the desired concentration
levels.
Note: The reagent, calibrator, calibration verification material and the quality
control are all packaged separately. |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | (1) Elecsys ACTH Reagent: Immunoassay for the in vitro quantitative
determination of adrenocorticotropic hormone (ACTH) in human EDTA
plasma. The electrochemiluminescence immunoassay "ECLIA" is intended
for use on the Roche Elecsys 1010/2010 and MODULAR ANALYTICS E
170 (Elecsys module) immunoassay analyzers.
(2) Elecsys ACTH CalSet is used for calibrating the quantitative Elecsys
ACTH assay on the Elecsys immunoassay analyzers.
(3) Elecsys ACTH CalCheck: For use in the verification of the calibration
established by the Elecsys ACTH reagent on Elecsys 1010/2010 and
MODULAR E170 immunoassay analyzers.
(4) Elesys PreciControl ACTH is used for quality control of the Elecsys
ACTH immunoassay on the Elecsys immunoassay analyzers. |

Continued on next page

and the same of the same of the same of the same of the same of the same of

510(k) Summary, Continued

Indications for Use	(1) Elecsys ACTH Reagent: Immunoasssay for the in vitro quantitative determination of adrenocorticotropic hormone (ACTH) in human EDTA plasma. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys 1010/2010 and MODULAR ANALYTICS E 170 (Elecsys module) immunoassay analyzers. ACTH measurments are used in the differential diagnosis and treatment of certain disorders of the adrenal glands such as Cushings syndrome, adrenocortical insufficiency, and the ectopic ACTH syndrome.
	(2) Elecsys ACTH CalSet is used for calibrating the quantitative Elecsys ACTH assay on the Elecsys immunoassay analyzers.
	(3) Elecsys ACTH CalCheck: For use in the verification of the calibration established by the Elecsys ACTH reagent on Elecsys 1010/2010 and MODULAR E170 immunoassay analyzers.
	(4) Elesys PreciControl ACTH is used for quality control of the Elecsys ACTH immunoassay on the Elecsys immunoassay analyzers.
Substantial equivalence	The Elecsys ACTH Test System is substantially equivalent to other devices legally marketed in the United States.
	(1) Elecsys ACTH Immunoassay is equivalent to the Immulite ACTH assay (K960066). Both products are intended for use in the quantitative determination of ACTH in plasma.
	(2) Elecsys ACTH CalSet is equivalent to the Immulite ACTH assay (K960066).
	(3) Elecsys ACTH CalCheck is equivalent to the Elecsys Prolactin II CalCheck (K053059).
	(4) Elecsys PreciControl ACTH is equivalent to the Elecsys PreciControl Troponin T (K031990).
	Continued on next page

510(k) Summary, Continued

Substantial equivalence - similarities

Substantial equivalence – similarities
Immunoassay Comparison
Feature	Elecsys ACTH	Predicate Device
Immulite ACTH Assay
Intended Use	Immunoassay for the in vitro quantitative determination of adrenocorticotropic hormone (ACTH) in human EDTA plasma. The electrochemiluminescence immunoassay “ECLIA” is intended for use on the Roche Elecsys 1010/2010 and MODULAR ANALYTICS E 170 (Elecsys module) immunoassay analyzers.	For in vitro diagnostic use with the Immulite 2000 analyzer - for the quantitative measurement of adrenocorticotropic hormone in EDTA, plasma, as an aid in the assessment of adrenal insufficiency and hypersecretion
Indication for Use	ACTH measurements are used in the differential diagnosis and treatment of certain disorders of the adrenal glands such as Cushings syndrome, adrenocortical insufficiency, and the ectopic ACTH syndrome.	As an aid in the assessment of adrenal insufficiency and hypersecretion.
Assay Protocol	Sandwich assay	Solid-phase, two site
Detection Protocol	Electrochemiluminescent Immunoassay	Chemiluminescent immunometric assay
Sample Type	Human plasma treated with K3-EDTA	Human plasma treated with EDTA
Calibrator	ACTH CalSet	ACTH Adjustors (LACL, LACH)

CalSet Comparison
Characteristic	Elecsys ACTH CalSet	Predicate Device
Immulite ACTH Assay
Intended Use	Used for calibrating the quantitative
Elecsys ACTH assay on the Elecsys
immunoassay analyzers.	N/A
Levels	Two	Same
Format	Lyophilized	Same
CalCheck Comparison
Characteristic	Elecsys ACTH CalCheck	Predicate Device
Elecsys Prolactin II CalCheck
Levels	Three	Same
Format	Lyophilized	Same
Stability	Unopened:
Store at 2-8°C up to the printed
expiration date on the bottle labels

Substantial equivalence – similarities, continued

510(k) Summary, Continued

Substantial equivalence - differences

Substantial equivalence – differences
Immunoassay Comparison
Feature	Elecsys ACTH	Predicate Device
Immulite ACTH Assay
Traceability /
Standardization	Standardized gravimetrically with
synthetic ACTH produced at Roche.	N/A
Calibration
Interval	E170/Elecsys 2010:
After 1 month (28 days) when using
the same reagent lot.
After 7 days (when using the same
reagent kit on the analyzer).
Elecsys 1010:
With every reagent kit.
After 7 days (20-25°C).
After 3 days (25-32°C).	Every four weeks.
Platform	Roche Elecsys 1010/2010 and
MODULAR ANALYTICS E170
(Elecsys module) analyzers.	Immulite 2000 Analyzer
Calibration
Verification	ACTH CalCheck	None stated in the package insert.
Controls	PreciControl ACTH	LACCM: Bi-level ACTH control
module (protein based)..
Reagent Stability	Unopened:
2-8°C - Up to the stated expiration
date

Opened:
2-8°C - 12 weeks
On the E170 / Elecsys 2010 – 4
weeks
On the Elecsys 1010: – 4 weeks
(stored alternately in the refrigerator
and on the analyzer- ambient
temperature 20-25°C; up to 20 hours
opened in total.) | ACTH Reagent Wedge:
Stable at 2 – 8°C until the expiration
date. | |
| Measuring
Range | 1 – 2,000 pg/mL | 5 – 1,250 pg/mL | |
| Feature | Elecsys ACTH | Predicate Device
Immulite ACTH Assay | |
| Precision | Elecsys 1010/2010:
Within-run
2.9% CV @ 4.9 pg/mL
2.0% CV @ 74.2 pg/mL
2.1% CV @ 1,390 pg/mL
1.5% CV @ 115 pg/mL
1.6% CV @ 970 pg/mL

Total
5.4% CV @ 4.9 pg/mL
2.4% CV @ 74.2 pg/mL
2.6% CV @ 1,390 pg/mL
1.7% CV @ 115 pg/mL
1.8% CV @ 970 pg/mL

E170:
Within-run
2.7% CV @ 4.9 pg/mL
0.6% CV @ 64.3 pg/mL
0.7% CV @ 1,205 pg/mL
0.6% CV @ 111 pg/mL
1.2% CV @ 968 pg/mL

Total
5.4% CV @ 4.96 pg/mL
3.5% CV @ 76.1 pg/mL
3.7% CV @ 1,444 pg/mL
1.8% CV @ 114 pg/mL
2.0% CV @ 972 pg/mL | Intra-assay:
8.7% CV @ 23 pg/mL
6.7% CV @ 30 pg/mL
6.8% CV @ 40 pg/mL
6.9% CV @ 208 pg/mL
9.5% CV @ 421 pg/mL

$y= 0.90x + 8.17, r = 0.992, n=180$ | DPC Immulite 2000 versus DPC Immulite:

$(IML 2000) = 0.95 (IML) + 2.9 pg/mL$
$r=0.988, n = 86$ | |
| Analytical
Specificity | No cross reactivity for:

ACTH (1-10)
ACTH (11-24)
Beta MSH
Beta Endorphin

ACTH fragments:
(ACTH 1-17, ACTH 1-24, ACTH
CLIP 18-39, ACTH 22-39, Alpha
MSH 1-13) > 5,000 pg/mL can bind
to one of the antibodies and thereby
negatively interfere with the
sandwich formation and lead to
lower ACTH values.

Under ACTH (1-24) medication,
ACTH measurement is not
recommended. POMC (partially
purified from an adenoma cell line)
showed an approximate 1.6% cross-
reactivity at 1,560 pmol/L which is
approximately forty times the
physiological concentration of
ACTH precursors in circulation. | No cross reactivity for:

ACTH (1-18)

Cross reactivity:
ACTH (1-24)
ACTH (18-39)
Alpha MSH | |
| Hook Effect | No high dose hook effect up to
1,000,000 pg/mL | No high dose hook effect up to
1,500,000 pg/mL | |
| Substantial equivalence – differences | | | |
| Immunoassay Comparison | | | |
| Feature | Elecsys ACTH | Predicate Device
Immulite ACTH Assay | |
| Limitations | The assay is unaffected by:
Icterus (bilirubin 5 mg/day), no sample should be taken until at least 8 hours after the last biotin administration No interference was observed from rheumatoid factors up to a concentration of 400 IU/mL In vitro tests were performed on 17 commonly used pharmaceuticals. No interference was found with the assay Under ACTH 1-24 medication, ACTH measurement is not recommended, due to negative interference with the sandwich assay | The assay is unaffected by:
Bilirubin: (Up to 200 mg/L) Hemolysis: (Up to 512 mg/dL) Lipemia: (Triglycerides up to 5,000 mg/dL) Heterophilic antibodies in human serum can react with the immunoglobulins included in the assay components causing interference with in vitro immunoassays. Samples from patients routinely exposed to animals or animal serum products can demonstrate this type of interference potentially causing an anomalous result. These reagents have been formulated to minimize the risk of interference, however, potential interactions between rare sera and test components can occur. | |

Substantial equivalence - differences

| Feature | Elecsys ACTH | Predicate Device
Immulite ACTH Assay |
|-------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Limitations | Erroneous findings may be obtained from samples taken from patients who have been treated with monoclonal antibodies or have received them for diagnostic purposes. In rare cases, interference due to extremely high titers of antibodies to ruthenium can occur. Elecsys ACTH contains additives which minimize these effects. Extremely high titers of antibodies to streptavidin can occur in isolated cases and cause interference. For diagnostic purposes, the results should always be assessed in conjunction with the patient's medical history, clinical examination and other findings | For diagnostics purposes, the results obtained from this assay should always be used in combination with the clinical examination, patient medical history, and other findings. |

Substantial equivalence - differences

CalSet Comparison
Substantial equivalence - differences
Characteristic	Elecsy ACTH CalSet	Predicate device
Immulite ACTH Assay
Matrix	Equine serum	Bovine protein-based
Stability	Unopened:
• Store at 2-8°C until expiration
date.
Reconstituted or thawed:
• 2-8°C: 1 week
• -20°C: 3 months (freeze only
once)
• on Elecsys 1010/2010 at 20-
25°C: Up to 5 hours
• on E170: Use only once	Reconstituted:
• -20°C: 2 months
Handling	Dissolve carefully the contents of
one bottle by adding exactly 1.0
mL of distilled water and allow to
stand closed for 15 minutes to
reconstitute. Mix carefully,
avoiding the formation of foam.	Reconstitute each vial with 4.0 mL
distilled or deionized water. Let stand
for 30 minutes, then mix by gentle
swirling or inversion.

Substantial equivalence -- differences

CalCheck Comparison
Characteristic	Elecsys ACTH CalCheck	Predicate device
Elecsys Prolactin II CalCheck
Intended Use	For use in the verification of the
calibration established by the
Elecsys ACTH reagent on Elecsys
1010/2010 and MODULAR E170
immunoassay analyzers.	For use in the verification of the
calibration established by the Elecsys
Prolactin II reagent on Elecsys
1010/2010 and MODULAR
ANALYTICS E170 immunoassay
analyzers.
Matrix	Buffered equine serum with
synthetic 1-39 ACTH.	Buffered equine serum with
recombinant human Prolactin from E.
Coli
Handling	Reconstitute the contents with
exactly 2.0 mL distilled water or
deionized water. Allow the bottle
to stand closed for 15 minutes. Mix
by inversion to ensure
homogeneity.	Reconstitute the contents with exactly
1.0 mL distilled or deionized water.
Allow the bottle to stand closed for 15
minutes. Mix by inversion to ensure
homogeneity.
Traceability	Standardized gravimetrically with
synthetic ACTH produced at
Roche.	Standardized against the 3rd IRP WHO
Reference Standard 84/500.

Substantial equivalence - differences

| | Characteristic | CalCheck Comparison
Elecsys ACTH CalCheck | Predicate device
Elecsys Prolactin II CalCheck |
|--------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|
| Intended Use | For use in the verification of the
calibration established by the
Elecsys ACTH reagent on Elecsys
1010/2010 and MODULAR E170
immunoassay analyzers. | For use in the verification of the
calibration established by the Elecsys
Prolactin II reagent on Elecsys
1010/2010 and MODULAR
ANALYTICS E170 immunoassay
analyzers. | |
| Matrix | Buffered equine serum with
synthetic 1-39 ACTH. | Buffered equine serum with
recombinant human Prolactin from E.
Coli | |
| Handling | Reconstitute the contents with
exactly 2.0 mL distilled water or
deionized water. Allow the bottle
to stand closed for 15 minutes. Mix
by inversion to ensure
homogeneity. | Reconstitute the contents with exactly
1.0 mL distilled or deionized water.
Allow the bottle to stand closed for 15
minutes. Mix by inversion to ensure
homogeneity. | |
| Traceability | Standardized gravimetrically with
synthetic ACTH produced at
Roche. | Standardized against the 3rd IRP WHO
Reference Standard 84/500. | |

Substantial equivalence - differences

Status and States of Children and Children and Children Children Children and Children Children Children Children Children Children Children Children Children Children Childr

510(k) Summary, Continued

PreciControl Comparison
Characteristic	Elecsy PreciControl ACTH	Predicate Device
Elecsys PreciControl Troponin T
Intended Use	Used for quality control of the
Elecsys ACTH immunoassay on
the Elecsys immunoassay
analyzers.	Used for quality control of the Elecsys
Troponin T (Cardiac T) immunoassay
on the Elecsys immunoassay systems.
Matrix	Equine serum with added synthetic
ACTH	Troponin T (recombinant, human) in
human serum
Stability	Unopened:
Store at 2-8°C up to the stated
expiration date	Unopened:
Store at 2-8°C up to the stated
expiration date
	Reconstituted:
On the analyzer at 20 - 25°C: Up to
three hours.	Reconstituted:
On the analyzer at 20 - 25°C: Up to
five hours.
	-20 °C : One month (freeze only
once)	-20 °C : Three months (freeze only
once)
	After thawing: Use only once.	After thawing: Use only once.

Substantial equivalence – differences

・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/14/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three bars representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 3 2006

Randy Johnson MT (ASCP) Regulatory Affairs Consultant Roche Diagnostics 9115 Hague Road PO Box 50416 Indianapolis, IN 46250-0416

K060585 Re:

Trade/Device Name: Elecsys ACTH Test System Regulation Number: 21 CFR§862.1025 Regulation Name: Adrenocorticotropic hormone (ACTH) test system Regulatory Class: Class II Product Code: CKG, JIT, JJX Dated: March 6, 2006 Received: March 7, 2006

Dear Mr. Johnson:

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).

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
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

Indications for Use

510(k) Number (if known): K060585

Elecsys ACTH Test System Device Name:

Indications For Use:

Elecsys ACTH Assay:

Immunoassay for the in vitro quantitative determination of adrenocorticotropic hormone (ACTH) in human EDTA plasma. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys 1010/2010 and MODULAR ANALYTICS E 170 (Elecsys module) immunoassay analyzers. ACTH measurements are used in the differential diagnosis and treatment of certain disorders of the adrenal glands such as Cushings syndrome, adrenocortical insufficiency, and the ectopic ACTH syndrome.

Elecsys ACTH CalSet is used for calibrating the quantitative Elecsys ACTH assay on the Elecsys immunoassay analyzers.

Elecsys ACTH CalCheck:

For use in the verification of the calibration established by the Elecsys ACTH reagent on Elecsys 1010/2010 and MODULAR E170 immunoassay analyzers.

Elecsys PreciControl ACTH is used for quality control of the Elecsys ACTH immunoassay on the Elecsys immunoassay analyzers.

Prescription Use XXX (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 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

Office of In Vitro Diagnostic Device Evaluation and Safety

310(k) kAlosys

Page 1 of 1

Replacement Page 28