ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH

• K Number: K110830
• Device Name: ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH
• Manufacturer: ELITECHGROUP
• Date Cleared: 2011-06-21 ( 88 days)
• Product Code: CIX CJY JIX JJY
• Regulation Number: 862.1035

Intended Use

ELITech Clinical Systems CALCIUM ARSENAZO is intended for the quantitative in vitro diagnostic determination of total calcium in human serum and plasma on ELITech Clinical Systems Selectra analyzers. It is not intended for use in Point of Care settings. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). ELITech Clinical Systems ALBUMIN is intended for the quantitative in vitro diagnostic determination of albumin in human serum and plasma on ELITech Clinical Systems Selectra analyzers. It is not intended for use in Point of Care settings. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys. ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra analyzers. ELITech Clinical Systems ELITROL I & ELITROL II are multi-parametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra analyzers.

Device Description

The device for this submission is available as kit only. It consists of 1 reagent "R". Reagent R contains: MES buffer (pH 6.50), Arsenazo III [2,7-(bis(2-arsonophenylazo))-1,8-dihydronaphtalene-3,6-disulphonic acid]. The device for this submission is available as kit only. It consists of 1 reagent "R". Reagent R contains: Succinate buffer (pH 4.20), Bromocresol green, Brij 35. ELITech Clinical Systems ELICAL 2 is a lyophilized calibrator based on human serum containing constituents to ensure optimal calibration. ELICAL 2 is prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A. ELITech Clinical Systems ELITROL I and ELITROL II are two level quality control products consisting of lyophilized human serum containing constituents at desired levels. Elitrol I and Elitrol II are prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.

Predicate Devices

K921625, K063744, K033501, K041227, K041227

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use focus on chemical reagents and calibrators for in vitro diagnostic tests, with no mention of AI or ML technologies.

Therapeutic

No.
The device is described as an "in vitro diagnostic" for measuring substances in human samples, which is used for diagnosis and treatment planning, not for direct therapeutic intervention.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the devices are for "quantitative in vitro diagnostic determination" of substances like total calcium and albumin, and that these measurements "are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany" or "numerous diseases involving primarily the liver or kidneys."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "kit only" consisting of reagents and lyophilized human serum products, which are physical components, not software.

IVD (In Vitro Diagnostic)

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

The "Intended Use / Indications for Use" section explicitly states that the devices are intended for "quantitative in vitro diagnostic determination" of various substances in human serum and plasma. This directly aligns with the definition of an In Vitro Diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, treatment, or prevention of disease.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

ELITech Clinical Systems CALCIUM ARSENAZO is intended for the quantitative in vitro diagnostic determination of total calcium in human serum and plasma on ELITech Clinical Systems Selectra analyzers.
It is not intended for use in Point of Care settings.
Calcium measurements are used in the diagnosis and treatment of parathyroid disease. a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

ELITech Clinical Systems ALBUMIN is intended for the quantitative in vitro diagnostic determination of albumin in human serum and plasma on ELITech Clinical Systems Selectra analyzers.
It is not intended for use in Point of Care settings.
Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra analyzers.

ELITech Clinical Systems ELITROL I & ELITROL II are multi-parametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra analyzers.

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

CJY, CIX, JIX, JJY

Device Description

The device for this submission is available as kit only. It consists of 1 reagent "R".
Reagent R contains: MES buffer (pH 6.50), Arsenazo III [2,7-(bis(2-arsonophenylazo))-1,8-dihydronaphtalene-3,6-disulphonic acid].

The device for this submission is available as kit only. It consists of 1 reagent "R".
Reagent R contains: Succinate buffer (pH 4.20), Bromocresol green, Brij 35.

ELITech Clinical Systems ELICAL 2 is a lyophilized calibrator based on human serum containing constituents to ensure optimal calibration.
ELICAL 2 is prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.

ELITech Clinical Systems ELITROL I and ELITROL II are two level quality control products consisting of lyophilized human serum containing constituents at desired levels.
Elitrol I and Elitrol II are prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.

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)

Method comparison for ELITech Clinical Systems CALCIUM ARSENAZO: y= 1.008 x - 0 mg/dL, r= 0.996, range: 4.90 to 14.37 mg/dL.
Method comparison for ELITech Clinical Systems ALBUMIN: y= 0.961x + 0.12 g/dL, r= 0.997, range: 1.43 to 5.89 g/dL.

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

Not Found

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.

Stanbio Calcium LiquiColor® (Arsenazo III) (K921625), Roche Diagnostics Albumin Gen.2 (K063744), Roche Diagnostics Calibrator for Automated Systems (C.f.a.s) (K033501), Roche Diagnostics Precinorm U (K041227), Roche Diagnostics Precipath U (K041227)

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

§ 862.1035 Albumin test system.

(a)
Identification. An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.(b)
Classification. Class II.

Summary

0

.

SECTION 5 - 510(k) Summary

---

| Introduction | According to the requirements of 21 CFR 807.92, the following information
provides sufficient detail to understand the basis for a determination of sub-
stantial equivalence. | |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The assigned 510(k) number is: K 110830 JUN: 2. 1 2011 | |
| Submitter | SEPPIM S.A.S. | |
| Address | Zone Industrielle, 61500 SEES, FRANCE | |
| Phone number | + 33 (0)2 33 81 21 00 | |
| Fax number | + 33 (0)2 33 28 77 51 | |
| Contact | Valérie GOURDON (Email: [e-mail]) | |
| Date of Preparation | March 24th, 2011 | |
| Device names | | |
| REAGENT
Trade/proprietary Name: | ELITech Clinical Systems CALCIUM ARSENAZO | |
| Common or Usual Name: | Calcium, “CALCIUM ARSENAZO” | |
| Device Class | Class II | |
| Classification name | Calcium test system (Sec.862.1145) | |
| Product code | CJY- Azo Dye, Calcium | |
| Predicate device | Stanbio Calcium LiquiColor® (Arsenazo III) (K921625) | |
| Device description | The device for this submission is available as kit only. It consists of 1
reagent "R".
Reagent R contains: MES buffer (pH 6.50), Arsenazo III [2,7-(bis(2-
arsonophenylazo))-1,8-dihydronaphtalene-3,6-disulphonic acid]. | |
| Intended Use | ELITech Clinical Systems CALCIUM ARSENAZO is intended for the
quantitative in vitro diagnostic determination of total calcium in human serum
and plasma on ELITech Clinical Systems Selectra analyzers.
It is not intended for use in Point of Care settings. | |
| Indication for use | Calcium measurements are used in the diagnosis and treatment of parathy-
roid disease, a variety of bone diseases, chronic renal disease and tetany
(intermittent muscular contractions or spasms). | |
| | ELITech Clinical Systems Device
(CALCIUM ARSENAZO) | Predicate device
(Stanbio Calcium LiquiColor®
(Arsenazo III) K921625) |
| Intended use | Intended for the quantitative in vitro
diagnostic determination of total cal-
cium in human serum and plasma on
ELITech Clinical Systems Selectra
analyzers.
It is not intended for use in Point of
Care settings. | For the quantitative colorimetric de-
termination of calcium in human serum
and plasma on Stanbio Laboratory
Sirrus Chemistry Analyzer. |
| Indication for Use | Calcium measurements are used in
the diagnosis and treatment of para-
thyroid disease, a variety of bone
diseases, chronic renal disease and
tetany (intermittent muscular contrac-
tions or spasms). | Calcium measurements are used in
the diagnosis and treatment of para-
thyroid disease, a variety of bone dis-
eases, chronic renal disease and teta-
ny (intermittent muscular contractions
or spasms). |
| Assay protocol | Colorimetric test | Colorimetric test |
| Composition | Reagent R:
MES buffer (pH 6.50) 100 mmol/L ;
Arsenazo III 200 µmol/L ; | Reagent :
Buffer :
Arsenazo III > 0.15 mmol/L ;
8-Hydroxyquinoline sulfonate 5.0 mM;
Surfactant |
| Appearance of re-agents | Liquid form, ready to use | Liquid form, ready to use |
| Sample type | Serum
Plasma | Serum
Plasma |
| Reagent storage | Store at 2-8 °C and protect from light.
The reagent is stable until the expiry
date stated on the label. | Store at 2-30 °C the reagent is stable
until the expiry date stated on the la-
bel. |
| Expected values | Serum/plasma:
8.6 - 10.3 mg/dL | Serum/plasma:
8.5 - 10.4 mg/dL |
| Instrument | Selectra ProM Analyzer | Sirrus Chemistry Analyzer |
| Measuring range | 5.0 - 15.0 mg/dL | 0 to 15 mg/dL |
| Limit of detection
(LoD) | 0.36 mg/dL | |
| Limit of quantification
(LoQ) | 5.00 mg/dL | |
| Precision | Within run | Within run |
| | Level 8.75 mg/dL CV= 1.3% | Level 11.0 mg/dL CV=1.3% |
| | Level 9.68 mg/dL CV= 0.9% | Level 14.3 mg/dL CV=0.9% |
| | Level 11.97 mg/dL CV=0.7% | |
| | Total | Run to run |
| | Level 8.75 mg/dL CV= 1.9% | Level 11.2 mg/dL CV=1.1% |
| | Level 9.68 mg/dL CV= 1.9% | Level 14.3. mg/dL CV=1.3% |
| | Level 11.97 mg/dL CV= 1.9% | |
| Method comparison | y= 1.008 x - 0 mg/dL
r= 0.996
range: 4.90 to 14.37 mg/dL | y= 0.99 x + 0.10 mg/dL
r= 0.989
range: 4.7 to 15.9 mg/dL |
| Limitations | Hemoglobin: No significant interfer-
ence up to 500 mg/dL. | Bilirubin: No interference up to 20
mg/dL. |
| | ELITech Clinical Systems Device
(CALCIUM ARSENAZO) | Predicate device
(Stanbio Calcium LiquiColor®
(Arsenazo III) K921625) |
| | Triglycerides: No significant interference up to 1119 mg/dL. A positive
bias is observed with triglycerides
concentratsion above 1119 mg/dL.
Unconjugated bilirubin: No signifi-
cant interference up to 30.0 mg/dL
(513 µmol/L).
Conjugated bilirubin: No significant
interference up to 29.5 mg/dL (504
µmol/L).
Magnesium: No significant interfer-
ence up to 10.91 mg/dL.
Ascorbic acid: No significant interfer-
ence up to 20 mg/dL.
Acetaminophen: No significant inter-
ference up to 30 mg/dL.
Acetylsalicylic acid: No significant
interference up to 200 mg/dL. | Hemoglobin: No interference up to
500 mg/dL.
Lipemia: May cause elevated results. |
| Calibration Frequency | 28 days | 30 days |
| On board stability | refrigerated area : 28 days | 30 days |
| Calibrator | Recommended calibration material
(not included):
ELITech Clinical Systems ELICAL 2 | Recommended calibration material
(not included):
Ser-T-Cal® MultiCalibrator |
| Controls | Recommended quality control material
(not included):
ELITech Clinical Systems ELITROL I
(Normal control)
ELITech Clinical Systems ELITROL II
(Pathologic control) | Recommended quality control material
(not included):
Ser-T-Fy® I (Normal control)
Ser-T-Fy® II (Abnormal control) |

1

2

| Device names

REAGENT
Trade/proprietary Name:	ELITech Clinical Systems ALBUMIN
Common or Usual Name:	Albumin, "ALBUMIN"
Device Class	Class II
Classification name	Albumin test system (Sec.862.1035)
Product code	CIX - Bromcresol green dye-binding, Albumin
Predicate device	Roche Diagnostics Albumin Gen.2 (K063744)
Device description	The device for this submission is available as kit only. It consists of 1
reagent "R".
Reagent R contains: Succinate buffer (pH 4.20), Bromocresol green, Brij 35.
Intended Use	ELITech Clinical Systems ALBUMIN is intended for the quantitative in vitro
diagnostic determination of albumin in human serum and plasma on ELI-
Tech Clinical Systems Selectra analyzers. It is not intended for use in Point
of Care settings.
Indication for use	Albumin measurements are used in the diagnosis and treatment of numer-
ous diseases involving primarily the liver or kidneys.

3

| | ELITech Clinical Systems Device
(ALBUMIN) | Predicate device
(Roche Diagnostics Albumin Gen.2
K063744) |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Intended for the quantitative in vitro
diagnostic determination of albumin in
human serum and plasma on ELITech
Clinical Systems Selectra analyzers.
It is not intended for use in Point of
Care settings. | For in vitro diagnostic use in the quan-
titative determination of albumin in
human serum and plasma on the co-
bas c111 system. |
| Indication for Use | Albumin measurements are used in
the diagnosis and treatment of numer-
ous diseases involving primarily the
liver or kidneys. | Albumin measurements are used in
the diagnosis and treatment of numer-
ous diseases involving primarily the
liver or kidneys. |
| Assay protocol | Colorimetric test | Colorimetric test |
| Composition | Reagent R:
Succinate buffer (pH 4.20) 87 mmol/L;
Bromocresol green 0.2 mmol/L;
Brij 35 7.35 mL/L; | Reagent R1:
Citrate (pH 4.1) 95 mmol/L;
Preservative

Reagent R2:
Citrate (pH 4.1) 95 mmol/L;
Bromocresol green 0.66 mmol/L;
Preservative |
| Appearance of reagents | Liquid form, ready to use | Liquid form, ready for use |
| Sample type | Serum
Plasma | Serum
Plasma |
| Reagent storage | Store at 2-25 °C and protect from light.
The reagent is stable until the expiry
date stated on the label. | Stored at 15-25 °C.
Reagents are stable until the expiry
date stated on the label. |
| Expected values | Serum, plasma:
Adults: 3.5-5.2 g/dL
60-90 years : 3.2-4.6 g/dL

90 years: 2.9-4.5 g/dL
In ambulatory patients, values aver-
age ~0.3 g/dL higher. | Serum/plasma:
Adults (reference range study) : 3.97-
4.94 g/dL
Adults (consensus values) : 3.5-5.2
g/dL
Tietz:
0-4 days : 2.8-4.4 g/dL
4 days-14 years: 3.8-5.4 g/dL
14 -18 years: 3.2-4.5 g/dL |
| Instrument | Selectra ProM Analyzer | Cobas c111 |
| Measuring range | 1.6 - 6.0 g/dL | 0.2 to 6.0 g/dL |
| Limit of detection
(LoD) | 0.003 g/dL | 0.2 g/dL |
| Limit of quantification
(LoQ) | 0.50 g/dL | |
| Precision | Within run | Within run |
| | Level 2.54 g/dL CV= 0.9%
Level 3.53 g/dL CV= 0.5%
Level 4.98 g/dL CV= 0.8% | Level 4.67 g/dL CV=0.52%
Level 2.99 g/dL CV=0.76%
Level 3.01 g/dL CV=0.56%
Level 5.48 g/dL CV=0.61% |
| | Total | Run to run |
| | ELITech Clinical Systems Device
(ALBUMIN) | Predicate device
(Roche Diagnostics Albumin Gen.2
K063744) |
| | Level 2.54 g/dL CV= 2.3%
Level 3.53 g/dL CV=2.1%
Level 4.98 mg/dL CV=2.1% | Level 4.62 g/dL CV=1.87%
Level 2.97 g/dL CV=1.45%
Level 2.98 g/dL CV=1.83%
Level 5.40 g/dL CV=1.24% |
| Method comparison | y= 0.961x + 0.12 g/dL
r= 0.997
range: 1.43 to 5.89 g/dL. | y= 1.017 x + 0.0164 g/dL
r= 0.9997
range: 0.26 to 5.93 g/dL |
| Limitations | Hemoglobin: No significant interfer-
ence up to 500 mg/dL.
Triglyceride: No significant interfer-
ence up to 3000 mg/dL.
Unconjugated bilirubin: No signifi-
cant interference up to 30.0 mg/dL
(513 µmol/L).
Conjugated bilirubin: No significant
interference up to 29.5 mg/dL (504
µmol/L).
Ascorbic acid: No significant interfer-
ence up to 20 mg/dL.
Acetaminophen: No significant inter-
ference up to 30 mg/dL.
Acetylsalicylic acid: No significant
interference up to 200 mg/dL.
γ-globulin: No significant interference
up to 1500 mg/dL. | Hemoglobin: No significant interfer-
ence up to an H Index of 420 (ap-
proximate 420 mg/dL).
Lipemia (Intralipid): No significant
influence up to an L index of 900.
There is poor correlation between the
L index (corresponds to turbidity) and
triglycerides concentration.
Icterus: No significant influence up to
I Index of 60 (approximate conju-
gated and unconjugated bilirubin con-
centration of 60 mg/dL (1026 µmol/L)).
γ-globulin: No significant interference. |
| Calibration Frequency | 28 days | Each lot and as required following
quality control procedures. |
| On board stability | refrigerated area : 28 days | 4 weeks |
| Calibrator | Recommended calibration material
(not included):
ELITech Clinical Systems ELICAL 2 | Recommended calibration material
(not included):
Roche Calibrator f.a.s. |
| Controls | Recommended quality control material
(not included):
ELITech Clinical Systems ELITROL I
(Normal control)
ELITech Clinical Systems ELITROL II
(Pathologic control) | Recommended quality control material
(not included):
Roche Precinorm U
Roche Precipath U |

4

Device name

CALIBRATOR :
Trade/proprietary Name:	ELITech Clinical Systems ELICAL 2
Common or Usual Name:	Calibrator, multi-analyte mixture, "ELICAL 2"
Device Class	Class II
Classification name	Calibrator (21 CFR 862.1150)
Product code	JIX- Calibrator, multi-analyte mixture

5

Predicate device	Roche Diagnostics Calibrator for Automated Systems (C.f.a.s) (K033501)
Device description	ELITech Clinical Systems ELICAL 2 is a lyophilized calibrator based on
human serum containing constituents to ensure optimal calibration.
ELICAL 2 is prepared exclusively from the blood of donors tested individually
and found to be negative for HbsAg and to antibodies to HCV and HIV ac-
cording to FDA-approved methods or methods in compliance with the Euro-
pean Directive 98/79/EC, Annex II, List A.
Intended Use	ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in
vitro diagnostic use in the calibration of quantitative ELITech Clinical Sys-
tems methods on ELITech Clinical Systems Selectra Analyzers.

Comparison to Predicate device

.

| | ELITech Clinical Systems Device
(ELICAL 2) | Predicate device
(Roche Calibrator f.a.s. K033501) |
|--------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | ELITech Clinical Systems ELICAL
2 is a multi-parametric calibrator
for in vitro diagnostic use in the
calibration of quantitative ELITech
Clinical Systems methods on
ELITech Clinical Systems Selec-
tra Analyzers. | For in vitro diagnostic use in the
calibration of quantitative Roche
methods on Roche clinical chemis-
try analysers as specified in the
value sheets. |
| Format | Lyophilized calibrator based on
human serum with constituents
added as required to obtain desired
components levels | Lyophilized calibrator based on
human serum with constituents
added as required to obtain desired
components levels |
| Level | Single level | Single level |
| Handling | Carefully open the vial, avoiding the
loss of lyophilizate, and pipette in
exactly 3 mL of distilled/deionized
water. Carefully close the vial and
dissolve the contents completely by
occasional gentle swirling within 30
minutes avoiding the formation of
foam. | Carefully open one bottle, avoiding
the loss of lyophilizate, and pipette
in exactly 3 mL of distilled/deionized
water. Carefully close the bottle and
dissolve the contents completely by
occasional gentle swirling within 30
minutes. Avoid the formation of
foam. |
| Traceability | Traceability information is given in
the value sheet included in the box. | Traceability of the target value is
given in the respective instruction
for use of the system reagents. |
| Stability | Lyophilized:
To store at 2-8°C and protected
from light until the expiry date | Lyophilized:
Stable at 2-8°C up to expiration
date. |
| | After reconstitution, the stabilities
are : | After reconstitution, the stabilities*
are : |
| | Between 15-25 °C :
8 hours | - 8 hours at 15-25 °C. |

6

| Between 2-8 °C :
Between (-25)-(-15) °C : 4 weeks
(when frozen once) | 2 days | - 2 days at 2-8 °C.

• 4 weeks at Between (-25)-(-15) °C
  (when frozen once) | |
  |----------------------------------------------------------------------------------------|---------|------------------------------------------------------------------------------------------------------------------|---------|
  | Exceptions :
• Stability of direct bilirubin (when
  stored protected from light): | | Exception for bilirubin total & direct
• Stability of direct bilirubin (when
  stored protected from light): | |
  | Between 15-25 °C: | 3 hours | Between 15-25 °C: | 3 hours |
  | Between 2-8 °C:
  Between (-25)-(-15) °C: 2 weeks
  (when frozen once) | 8 hours | Between 2-8 °C
  Between (-25)-(-15) °C: 2 weeks
  (when frozen once) | 8 hours |
  | - Stability of total bilirubin (when
  stored protected from light): | | - Stability of total bilirubin (when
  stored protected from light): | |
  | Between 15-25 °C: | 6 hours | Between 15-25 °C: | 6 hours |
  | Between 2-8 °C:
  Between (-25)-(-15) °C: 2 weeks
  (when frozen once) | 1 day | Between 2-8 °C:
  Between (-25)-(-15) °C: 2 weeks
  (when frozen once) | 1 day |

Device names

.

| CONTROLS:

Trade/proprietary Name:	ELITech Clinical Systems ELITROL I and ELITROL II
Common or Usual Name:	Multi-analyte controls - all kinds, "ELITROL I"- "ELITROL II"
Device Class	Class I
Classification name	Quality control material (assayed and unassayed). (21 CFR 862.1660)
Product code	JJY- Multi-analyte controls - all kinds
Predicate device	Roche Diagnostics Precinorm U (K041227)
Roche Diagnostics Precipath U (K041227)
Device description	ELITech Clinical Systems ELITROL I and ELITROL II are two level quality
control products consisting of lyophilized human serum containing constitu-
ents at desired levels.
Elitrol I and Elitrol II are prepared exclusively from the blood of donors tested
individually and found to be negative for HbsAg and to antibodies to HCV and
HIV according to FDA-approved methods or methods in compliance with the
European Directive 98/79/EC, Annex II, List A.
Intended Use	ELITech Clinical Systems ELITROL I and ELITROL II are multi-parametric
control sera for in vitro diagnostic use in quality control of quantitative ELITech
Clinical Systems methods on ELITech Clinical Systems Selectra Analyzers.

7

| | ELITech Clinical Systems Device
(ELITROL I / ELITROL II) | Predicate Device
(Roche Precinorm U / Precipath U
K041227) |
|--------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | ELITech Clinical Systems ELITROL I and ELITROL II are multi- parametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Sys- tems methods on ELITech Clinical Systems Selectra Analyzers. | For in vitro diagnostic use in quality control by monitoring accuracy and precision for the quantitative.meth- ods as specified in the value sheet |
| Format | Lyophilized human sera with con- stituents added as required to ob- tain desired components levels | Lyophilized human sera with con- stituents added as required to ob- tain desired components levels |
| Levels | Two levels | Two levels |
| Handling | Carefully open the vial, avoiding the loss of lyophilizate, and pipette in exactly 5 mL of distilled/deionized water. Carefully close the vial and dissolve the contents completely by occasional gentle swirling within 30 minutes avoiding the formation of foam. | Carefully open the bottle, avoiding the loss of lyophilizate, and pipette in exactly 5 mL of distilled/deionized water. Carefully close the bottle and dissolve the contents completely by occasional gentle swirling within 30 minutes. Avoid the formation of foam. |
| Stability | Lyophilized:
To store at 2-8°C and protected from light until the expiry date
After reconstitution, the stabilities are :
Between 15-25 °C : 12 hours
Between 2-8 °C : 5 days
Between (-25)-(-15) °C : 4 weeks (when frozen once)
Exceptions:

• Stability of direct bilirubin (when stored protected from light):
  Between 15-25 °C: 4 hours
  Between 2-8 °C: 8 hours
  Between (-25)-(-15) °C: 2 weeks (when frozen once)
• Stability of total bilirubin (when stored protected from light):
  Between 15-25 °C: 8 hours
  Between 2-8 °C: 1 day
  Between (-25)-(-15) °C: 2 weeks (when frozen once) | Lyophilized:
  Stable at 2-8°C up to expiration date.
  After reconstitution, the stabilities * are :
• 12 hours at 15-25 °C.
• 5 days at 2-8 °C.
• 4 weeks at (-25)-(-15) °C (when frozen once)
  *Exception for bilirubin total & direct as noted in package insert:
• Stability of direct bilirubin (when stored protected from light):
  Between 15-25 °C: 4 hours
  Between 2-8 °C: 8 hours
  Between (-25)-(-15) °C: 2 weeks (when frozen once)
• Stability of total bilirubin (when stored protected from light):
  Between 15-25 °C: 8 hours
  Between 2-8 °C: 24 hours
  Between (-25)-(-15) °C: 2 weeks (when frozen once) |

8

Conclusion The performance data and other information demonstrate that the safety and effectiveness of these devices versus the predicate devices are not compromised, and that it met all acceptance criteria, demonstrating that the device is substantially equivalent to its respective predicate device.

9

---

Device name

| CALIBRATOR :

Trade/proprietary Name:	ELITech Clinical Systems ELICAL 2
Common or Usual Name:	Calibrator, multi-analyte mixture, "ELICAL 2"
Device Class	Class II
Classification name	Calibrator (21 CFR 862.1150)
Product code	JIX- Calibrator, multi-analyte mixture
Predicate device	Roche Diagnostics Calibrator for Automated Systems (C.f.a.s) (K033501)
Device description	ELITech Clinical Systems ELICAL 2 is a lyophilized calibrator based on
human serum containing constituents to ensure optimal calibration.
ELICAL 2 is prepared exclusively from the blood of donors tested individually
and found to be negative for HbsAg and to antibodies to HCV and HIV
according to FDA-approved methods or methods in compliance with the
European Directive 98/79/EC, Annex II, List A.
Intended Use	ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in
vitro diagnostic use in the calibration of quantitative ELITech Clinical
Systems methods on ELITech Clinical Systems Selectra Analyzers.

| | ELITech Clinical Systems Device
(ELICAL 2) | Predicate device
(Roche Calibrator f.a.s. K033501) |
|--------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | ELITech Clinical Systems ELICAL
2 is a multi-parametric calibrator
for in vitro diagnostic use in the
calibration of quantitative ELITech
Clinical Systems methods on
ELITech Clinical Systems
Selectra Analyzers. | For in vitro diagnostic use in the
calibration of quantitative Roche
methods on Roche clinical
chemistry analysers as specified in
the value sheets. |
| Format | Lyophilized calibrator based on
human serum with constituents
added as required to obtain desired
components levels | Lyophilized calibrator based on
human serum with constituents
added as required to obtain desired
components levels |
| Level | Single level | Single level |
| Handling | Carefully open the vial, avoiding the
loss of lyophilizate, and pipette in
exactly 3 mL of distilled/deionized
water. Carefully close the vial and
dissolve the contents completely by
occasional gentle swirling within 30
minutes avoiding the formation of
foam. | Carefully open one bottle, avoiding
the loss of lyophilizate, and pipette
in exactly 3 mL of distilled/deionized
water. Carefully close the bottle and
dissolve the contents completely by
occasional gentle swirling within 30
minutes. Avoid the formation of
foam. |
| Traceability | Traceability information is given in
the value sheet included in the box. | Traceability of the target value is
given in the respective instruction
for use of the system reagents |

10

. •

Stability
	Lyophilized:
To store at 2-8°C and protected
from light until the expiry date	Lyophilized:
Stable at 2-8°C up to expiration
date.
	After reconstitution, the stabilities
are :	After reconstitution, the stabilities*
are :
	Between 15-25 °C :
8 hours	- 8 hours at 15-25 °C.
	Between 2-8 °C :
2 days
Between (-25)-(-15) °C : 4 weeks
(when frozen once)	- 2 days at 2-8 °C.

• 4 weeks at Between (-25)-(-15) °C
  (when frozen once) |
  | | Exceptions :
• Stability of direct bilirubin (when
  stored protected from light): | Exception for bilirubin total & direct
• Stability of direct bilirubin (when
  stored protected from light): |
  | | Between 15-25 °C:
  3 hours | Between 15-25 °C:
  3 hours |
  | | Between 2-8 °C:
  8 hours
  Between (-25)-(-15) °C: 2 weeks
  (when frozen once) | Between 2-8 °C
  8 hours
  Between (-25)-(-15) °C: 2 weeks
  (when frozen once) |
  | | - Stability of total bilirubin (when
  stored protected from light): | - Stability of total bilirubin (when
  stored protected from light): |
  | | Between 15-25 °C:
  6 hours | Between 15-25 °C:
  6 hours |
  | | Between 2-8 °C:
  1 day
  Between (-25)-(-15) °C: 2 weeks
  (when frozen once) | Between 2-8 °C:
  1 day
  Between (-25)-(-15) °C: 2 weeks
  (when frozen once) |

11

---

Device names

| CONTROLS:

Trade/proprietary Name:	ELITech Clinical Systems ELITROL I and ELITROL II
Common or Usual Name:	Multi-analyte controls - all kinds, "ELITROL I"- "ELITROL II"
Device Class	Class I
Classification name	Quality control material (assayed and unassayed). (21 CFR 862.1660)
Product code	JJY- Multi-analyte controls - all kinds
Predicate device	Roche Diagnostics Precinorm U (K041227)
Roche Diagnostics Precipath U (K041227)
Device description	ELITech Clinical Systems ELITROL I and ELITROL II are two level quality
control products consisting of lyophilized human serum containing
constituents at desired levels.
Elitrol I and Elitrol II are prepared exclusively from the blood of donors tested
individually and found to be negative for HbsAg and to antibodies to HCV and
HIV according to FDA-approved methods or methods in compliance with the
European Directive 98/79/EC, Annex II, List A.
Intended Use	ELITech Clinical Systems ELITROL I and ELITROL II are multi-parametric
control sera for in vitro diagnostic use in quality control of quantitative ELITech
Clinical Systems methods on ELITech Clinical Systems Selectra Analyzers.

| | ELITech Clinical Systems Device
(ELITROL I / ELITROL II) | Predicate Device
(Roche Precinorm U / Precipath U
K041227) |
|--------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | ELITech Clinical Systems ELITROL
I and ELITROL II are multi-
parametric control sera for in vitro
diagnostic use in quality control of
quantitative ELITech Clinical
Systems methods on ELITech
Clinical Systems Selectra
Analyzers. | For in vitro diagnostic use in quality
control by monitoring accuracy and
precision for the quantitative
methods as specified in the value
sheet |
| Format | Lyophilized human sera with
constituents added as required to
obtain desired components levels | Lyophilized human sera with
constituents added as required to
obtain desired components levels |
| Levels | Two levels | Two levels |
| Handling | Carefully open the vial, avoiding the
loss of lyophilizate, and pipette in
exactly 5 mL of distilled/deionized
water. Carefully close the vial and
dissolve the contents completely by
occasional gentle swirling within 30
minutes avoiding the formation of
foam. | Carefully open the bottle, avoiding
the loss of lyophilizate, and pipette
in exactly 5 mL of distilled/deionized
water. Carefully close the bottle and
dissolve the contents completely by
occasional gentle swirling within 30
minutes. Avoid the formation of
foam. |
| Stability | Lyophilized:
To store at 2-8°C and protected
from light until the expiry date | Lyophilized:
Stable at 2-8°C up to expiration
date |

12

| ELITech Clinical Systems Device
(ELITROL I/ ELITROL II) | Predicate Device
(Roche Precinorm U/ Precipath U
K041227) |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| After reconstitution, the stabilities
are:
Between 15-25 °C:
12 hours
Between 2-8 °C:
5 days
Between (-25)-(-15) °C: 4 weeks
(when frozen once)
Exceptions:

• Stability of direct bilirubin (when
  stored protected from light):
  Between 15-25 °C:
  4 hours
  Between 2-8 °C:
  8 hours
  Between (-25)-(-15) °C: 2 weeks
  (when frozen once)
• Stability of total bilirubin (when
  stored protected from light):
  Between 15-25 °C:
  8 hours
  Between 2-8 °C:
  1 day
  Between (-25)-(-15) °C: 2 weeks
  (when frozen once) | After reconstitution, the stabilities*
  are:
• 12 hours at 15-25 °C.
• 5 days at 2-8 °C.
• 4 weeks at (-25)-(-15) °C (when
  frozen once)
  *Exception for bilirubin total & direct
  as noted in package insert:
• Stability of direct bilirubin (when
  stored protected from light):
  Between 15-25 °C:
  4 hours
  Between 2-8 °C:
  8 hours
  Between (-25)-(-15) °C: 2 weeks
  (when frozen once)
• Stability of total bilirubin (when
  stored protected from light):
  Between 15-25 °C:
  8 hours
  Between 2-8 °C:
  24 hours
  Between (-25)-(-15) °C: 2 weeks
  (when frozen once) |

Conclusion

The performance data and other information demonstrate that the safety and effectiveness of these devices versus the predicate devices are not compromised, and that it met all acceptance criteria, demonstrating that the device is substantially equivalent to its respective predicate device

13

Public Health Service

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/13/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three wing segments, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

SEPPIM S.A.S. Elitech Group Epoch Biosciences c/o Ms. Debra Hutson Director, Quality Assurance/Regulatory Affairs 21720 23rd Drive, S.E., Suite 150 Bothell, Washington 98021

Food & Drug Administration 10903 New Hampshire Avenue Building 66 · Silver Spring, MD 20993

JAN 21 2011

K110830 Re:

Trade Name: ELITech Clinical Systems Albumin, ELITech Clinical Systems Calcium Arsenazo, ELITech Clinical Systems Elical 2, ELITech Clinical Systems Elitrol I and II Regulation Number: 21 CFR §862.1035

Regulation Name: Albumin Test System

Regulatory Class: Class II Product Codes: CIX, CJY, JIX, JJY Dated: May 18, 2011 Received: May 19, 2011

Dear Ms. Hutson:

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good

14

Page 2 –

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

CJC.

Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

s

Enclosure

15

510(k) Number (if known): KIIO 830

ELITech Clinical Systems CALCIUM ARSENAZO Device Name:

Indications for Use:

ELITech Clinical Systems CALCIUM ARSENAZO is intended for the quantitative in vitro diagnostic determination of total calcium in human serum and plasma on ELITech Clinical Systems Selectra analyzers.

It is not intended for use in Point of Care settings.

Calcium measurements are used in the diagnosis and treatment of parathyroid disease. a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

Prescription Use × (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 OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Signature

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

510(k) K110830

Page 1 of 4

16

510(k) Number (if known): K ||0830

ELITech Clinical Systems ALBUMIN Device Name:

Indications for Use:

ELITech Clinical Systems ALBUMIN is intended for the quantitative in vitro diagnostic determination of albumin in human serum and plasma on ELITech Clinical Systems Selectra analyzers.

It is not intended for use in Point of Care settings.

Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Prescription Use × (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

AND/OR

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

P.i.i.g. on

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

510(k) 1