K Number

Device Name

ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS

Manufacturer

ELITECHGROUP SEPPIM S.A.S.

Date Cleared

2011-08-31

(251 days)

Product Code

LBS JIT JJY MRR

Regulation Number

862.1475

Intended Use

ELITech Clinical Systems CHOLESTEROL HDL SL 2G is intended for use with ELITech Clinical Systems CHOLESTEROL HDL 2G CALIBRATOR and ELITech Clinical Systems ELITROL I and ELITROL II on ELITech Clinical Systems Selectra analyzers for the quantitative in vitro diagnostic determination of High Density Lipoprotein (HDL) Cholesterol in human serum and plasma. It is not intended for use in Point of Care settings. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. ELITech Clinical Systems CHOLESTEROL HDL 2G CALIBRATOR is a calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems CHOLESTEROL HDL SL 2G on the ELITech Clinical Systems Selectra analyzers. ELITech Clinical Systems CHOLESTEROL LDL SL 2G is intended for use with ELITech Clinical Systems CHOLESTEROL LDL 2G CALIBRATOR and ELITech Clinical Systems ELITROL I and ELITROL II for the quantitative in vitro diagnostic determination of Low Density Lipoprotein (LDL) Cholesterol in human serum and plasma on ELITech Clinical Systems Selectra analyzers. It is not intended for use in Point of Care settings. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. ELITech Clinical Systems CHOLESTEROL LDL 2G CALIBRATOR is a calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems CHOLESTEROL LDL SL 2G 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 2 reagents, "R1" and "R2". Reagent R1 contains: Good's buffer, Cholesterol oxidase (CO bacterial), Peroxidase (horseradish), Ascorbate oxidase (bacterial), N,N-bis(4-sulphobutyl)-m-toluidine-disodium (DSBmT), Accelerator. Reagent R2 contains: Good's buffer, Cholesterol esterase (CHE bacterial), 4-Amino-Antipyrine (4-AA), detergent. ELITech Clinical Systems CHOLESTEROL HDL 2G CALIBRATOR is a lyophilized calibrator based on human serum containing lipoprotein from the various lipoprotein classes including high density lipoproteins and sodium azide as preservative. CHOLESTEROL HDL 2G CALIBRATOR 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. The device for this submission is available as kit only. It consists of 2 reagents, "R1" and "R2". Reagent R1 contains: MES buffer, Detergent 1, Cholesterol esterase (CHE bacterial), Cholesterol oxidase (CO bacterial), Peroxidase (horseradish), 4-Amino-Antipyrine (4-AA), Ascorbate oxidase (vegetal). Reagent R2 contains: MES buffer, Detergent 2, N,N-bis(4-sulphobutyl)-m-toluidine-disodium (DSBmT). ELITech Clinical Systems CHOLESTEROL LDL 2GCALIBRATOR is a lyophilized calibrator based on human serum containing lipoprotein from the various lipoprotein classes including low density lipoproteins and sodium azide as preservative. CHOLESTEROL LDL 2G CALIBRATOR is prepared from plasma donor units tested individually by FDA - approved methods and found to be negative for HbsAg, anti-HCV antibody and anti-HIV1&2 antibodies. 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.

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

K060854, K021316, K060854, K971573, K041227, K041227

Reference Devices

None

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on chemical reagents and calibrators for quantitative in vitro diagnostic determination of cholesterol levels, with no mention of AI or ML technologies.

Therapeutic

No
This device is for in vitro diagnostic determination of cholesterol levels, which is used for diagnosis and treatment of conditions, not for directly treating a condition itself.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states "quantitative in vitro diagnostic determination" for both HDL and LDL Cholesterol, and that "Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders". It also states that the calibrators and controls are "for in vitro diagnostic use".

SaMD (Software as a Medical Device)

The device description clearly states it is a "kit only" consisting of reagents and calibrators, which are physical components, not software.

IVD (In Vitro Diagnostic)

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

Here's why:

Explicit Statement in Intended Use: The "Intended Use / Indications for Use" section for all listed components (CHOLESTEROL HDL SL 2G, CHOLESTEROL HDL 2G CALIBRATOR, CHOLESTEROL LDL SL 2G, CHOLESTEROL LDL 2G CALIBRATOR, ELITROL I & ELITROL II) explicitly states they are for "in vitro diagnostic use".
Purpose of the Device: The devices are intended for the quantitative determination of substances (HDL and LDL Cholesterol) in human serum and plasma, which are biological samples taken from the body. This is a core characteristic of IVDs.
Clinical Application: The results of these tests are used in the "diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases," indicating a clinical purpose for the testing.
Use with Specific Analyzers: The devices are intended for use with ELITech Clinical Systems Selectra analyzers, which are instruments used in clinical laboratories for diagnostic testing.
Calibrators and Controls: The submission includes calibrators and control materials, which are essential components of an IVD system used to ensure the accuracy and reliability of the test results.

All of these factors clearly indicate that the ELITech Clinical Systems CHOLESTEROL HDL SL 2G, CHOLESTEROL HDL 2G CALIBRATOR, CHOLESTEROL LDL SL 2G, CHOLESTEROL LDL 2G CALIBRATOR, and ELITROL I & ELITROL II are intended for in vitro diagnostic use.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Reagent (ELITech Clinical Systems CHOLESTEROL HDL SL 2G): ELITech Clinical Systems CHOLESTEROL HDL SL 2G is intended for use with ELITech Clinical Systems CHOLESTEROL HDL 2G CALIBRATOR and ELITech Clinical Systems ELITROL I and ELITROL II on ELITech Clinical Systems Selectra analyzers for the quantitative in vitro diagnostic determination of High Density Lipoprotein (HDL) Cholesterol in human serum and plasma. It is not intended for use in Point of Care settings. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
Calibrator (ELITech Clinical Systems CHOLESTEROL HDL 2G CALIBRATOR): ELITech Clinical Systems CHOLESTEROL HDL 2G CALIBRATOR is a calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems CHOLESTEROL HDL SL 2G on the ELITech Clinical Systems Selectra analyzers.
Reagent (ELITech Clinical Systems CHOLESTEROL LDL SL 2G): ELITech Clinical Systems CHOLESTEROL LDL SL 2G is intended for use with ELITech Clinical Systems CHOLESTEROL LDL 2G CALIBRATOR and ELITech Clinical Systems ELITROL I and ELITROL II for the quantitative in vitro diagnostic determination of Low Density Lipoprotein (LDL) Cholesterol in human serum and plasma on ELITech Clinical Systems Selectra analyzers. It is not intended for use in Point of Care settings. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
Calibrator (ELITech Clinical Systems CHOLESTEROL LDL 2G CALIBRATOR): ELITech Clinical Systems CHOLESTEROL LDL 2G CALIBRATOR is a calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems CHOLESTEROL LDL SL 2G on ELITech Clinical Systems Selectra Analyzers.
Controls (ELITech Clinical Systems ELITROL I & ELITROL II): 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)

LBS, JIT, JJY, MRR

Device Description

ELITech Clinical Systems CHOLESTEROL HDL SL 2G: The device for this submission is available as kit only. It consists of 2 reagents, "R1" and "R2". Reagent R1 contains: Good's buffer, Cholesterol oxidase (CO bacterial), Peroxidase (horseradish), Ascorbate oxidase (bacterial), N,N-bis(4-sulphobutyl)-m-toluidine-disodium (DSBmT), Accelerator. Reagent R2 contains: Good's buffer, Cholesterol esterase (CHE bacterial), 4-Amino-Antipyrine (4-AA), detergent.
ELITech Clinical Systems CHOLESTEROL HDL 2G CALIBRATOR: ELITech Clinical Systems CHOLESTEROL HDL 2G CALIBRATOR is a lyophilized calibrator based on human serum containing lipoprotein from the various lipoprotein classes including high density lipoproteins and sodium azide as preservative. CHOLESTEROL HDL 2G CALIBRATOR 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.
ELITech Clinical Systems CHOLESTEROL LDL SL 2G: The device for this submission is available as kit only. It consists of 2 reagents, "R1" and "R2". Reagent R1 contains: MES buffer, Detergent 1, Cholesterol esterase (CHE bacterial), Cholesterol oxidase (CO bacterial), Peroxidase (horseradish), 4-Amino-Antipyrine (4-AA), Ascorbate oxidase (vegetal). Reagent R2 contains: MES buffer, Detergent 2, N,N-bis(4-sulphobutyl)-m-toluidine-disodium (DSBmT).
ELITech Clinical Systems CHOLESTEROL LDL 2G CALIBRATOR: ELITech Clinical Systems CHOLESTEROL LDL 2GCALIBRATOR is a lyophilized calibrator based on human serum containing lipoprotein from the various lipoprotein classes including low density lipoproteins and sodium azide as preservative. CHOLESTEROL LDL 2G CALIBRATOR is prepared from plasma donor units tested individually by FDA - approved methods and found to be negative for HbsAg, anti-HCV antibody and anti-HIV1&2 antibodies.
ELITech Clinical Systems ELITROL I and ELITROL II: 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

Human serum and plasma

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found for Intended User.
Not intended for use in Point of Care settings.

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)

ELITech Clinical Systems CHOLESTEROL HDL SL 2G:

Measuring range: 5 to 105 mg/dL
Limit of detection (LoD): 0.7 mg/dL
Limit of quantification (LoQ): 5.0 mg/dL
Precision:
- Within run: Level 31 mg/dL CV=1.4%, Level 56 mg/dL CV=0.7%, Level 87 mg/dL CV=1.4%
- Total: Level 31 mg/dL CV=3.0%, Level 56 mg/dL CV=2.8%, Level 87 mg/dL CV=3.3%
Method comparison: y=1.09x - 2.5 mg/dL, r^2 = 0.972, range: 5 to 105 mg/dL
Limitations: No significant interference for unconjugated bilirubin (up to 30 mg/dL), conjugated bilirubin (up to 29.5 mg/dL), hemoglobin (up to 500 mg/dL). Negative bias from 439 mg/dL triglycerides equivalent turbidity.

ELITech Clinical Systems CHOLESTEROL LDL SL 2G:

Measuring range: 15 to 380 mg/dL
Limit of Detection (LoD): 0.3 mg/dL
Limit of Quantification (LoQ): 10.0 mg/dL
Precision:
- Within run: Level 108 mg/dL CV=1.4%, Level 122 mg/dL CV=1.3%, Level 162 mg/dL CV=2.0%
- Total: Level 108 mg/dL CV=2.6%, Level 122 mg/dL CV=2.7%, Level 162 mg/dL CV=4.0%
Method comparison: y= 0.999 x - 0.5 mg/dL, r^2 = 0.993, range: 16-378 mg/dL
Limitations: Hemoglobin: No significant interference up to 500 mg/dL. Turbidity: No significant interference up to 614 mg/dL triglycerides equivalent. Unconjugated bilirubin: No significant interference up to 30 mg/dL. Conjugated bilirubin: No significant interference up to 29.5 mg/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.

ABX PENTRA HDL Direct CP (K060854), Ultra N-Geneous HDL Calibrator from Genzyme (K021316), ABX PENTRA LDL Direct CP (K060854), N-geneous LDL Calibrator from Genzyme (K971573), 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

§ 862.1475 Lipoprotein test system.

(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.

Summary

SECTION 5 - 510(k) Summary			ELITech Clinical Systems Device	Predicate device
ELITech Clinical Systems CHOLESTEROL HDL SL 2G AUG 3 1 2011			CHOLESTEROL HDL SL 2G	(ABX PENTRA HDL Direct CP, K060854)
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.	Intended use	Intended for use with ELITech Clinical
Systems CHOLESTEROL HDL 2G
CALIBRATOR and ELITech Clinical
Systems ELITROL I and ELITROL II on
ELITech Clinical Systems Selectra
analyzers for the quantitative in vitro
diagnostic determination of High
Density Lipoprotein (HDL) Cholesterol
in human serum and plasma. It is not
intended for use in Point of Care
settings.	For quantitative in Vitro determination of
High-Density Lipoprotein Cholesterol
(HDL-C) in human serum or plasma by
colorimetry.
	The assigned 510(k) number is: K103747	Indication(s) for Use	Intended to measure High Density
Lipoprotein (HDL) Cholesterol in
human serum and plasma. Lipoprotein
measurements are used in the
diagnosis and treatment of lipid
disorders (such as diabetes mellitus),
atherosclerosis, and various liver and
renal diseases.	Intended to measure High Density
Lipoprotein (HDL) Cholesterol in human
serum and plasma. Lipoprotein
measurements are used in the diagnosis
and treatment of lipid disorders (such as
diabetes mellitus), atherosclerosis, and
various liver and renal diseases.
Submitter
Address
Phone number
Fax number	SEPPIM S.A.S.
Zone Industrielle, 61500 SEES, FRANCE

33 (0)2 33 81 21 00
33 (0)2 33 28 77 51 | | | | Assay protocol | Enzymatic colorimetric test with
accelerator selective detergent | Enzymatic colorimetric test based on
accelerator Selective Detergent (without
the need for any off-line pretreatment or
centrifugation steps) |
| Contact | Valérie GOURDON (Email: v.gourdon@elitechgroup.com) | | | | Composition | Reagent R1:
Good's buffer ,pH 6.0 ;
Cholesterol oxidase in vitro diagnostic determination of High Density Lipoprotein (HDL) Cholesterol in human serum and plasma. It is not intended for use in Point of Care settings. | | | | | | |
| Indication(s) for Use | ELITech Clinical Systems CHOLESTEROL HDL SL 2G is intended to measure High Density Lipoprotein (HDL) Cholesterol in human serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. | | | | | | |

	ELITech Clinical Systems Device	Predicate device
	CHOLESTEROL HDL SL 2G	(ABX PENTRA HDL Direct CP, K060854)
	light. The reagents are stable until the
expiry date stated on the label.	stable up to expiry date on the label if
stored at 2-8 °C.
Expected values	According to NCEP classification
according to the risk of developping
coronary heart disease	According to NCEP classification
according to the risk of developping
coronary heart disease
	High : in vitro diagnostic use in the
calibration of quantitative ELITech Clinical
Systems CHOLESTEROL HDL SL 2G on
ELITech Clinical Systems Selectra
analyzers.	For the calibration of Ultra N-Genous
HDL Cholesterol
Submitter
Address
Phone number
Fax number	SEPPIM S.A.S.
Zone Industrielle, 61500 SEES, FRANCE

33 (0)2 33 81 21 00
33 (0)2 33 28 77 51 | | Format | Lyophilized calibrator based on human
serum on human serum containing
lipoprotein from the various lipoprotein
classes including high density
lipoproteins. This calibrator contains
sodium azide as preservative. | Lyophilized calibrator based on human
serum on human serum containing
lipoprotein from the various lipoprotein
classes including high density
lipoproteins. This calibrator contains
sodium azide as preservative. |
| Contact | Valérie GOURDON (Email: v.gourdon@elitechgroup.com) | | Level | Single level | Single level |
| Date of Preparation | November, 23rd, 2010 | | Handling | Carefully open the vial, avoiding the loss
of lyophilizate, and pipette in exactly 1 mL
of distilled/deionized water. Carefully
close the vial and dissolve the content by
successive swirling. Wait for around 20
minutes until the complete dissolution and
homogenize again. Do not shake strongly
to avoid formation of foam. | Carefully open the vial, avoiding the loss
of lyophilizate, and reconstitute with 1
mL of deionized water. Close the vial
and let stand for 20 minutes. Dissolve
the contents of the vial by swirling gently
to avoid the formation of foam. Do not
shake. |
| Device names | | | Stability | Lyophilized:
To store at 2-8 °C and protected from light
until the expiry date | Lyophilized:
To store at 2-8 °C and protected from
light until the expiry date |
| Trade/proprietary Name
Common or Usual Name
Device Class
Classification name
Product code | ELITech Clinical Systems CHOLESTEROL HDL 2G CALIBRATOR
Calibrator "CHOLESTEROL HDL 2G CALIBRATOR"
Class II
Calibrator (Sec.862.1150)
JIS- Calibrator, Primary | | | After reconstitution, the stabilities are :

14 days between 2 - 8 °C.
4 weeks at less than - 80 °C (when
frozen once) | After reconstitution, the stabilities are :
14 days between 2 - 8 °C.
4 weeks between -70 °C (when frozen
once) |
| Predicate device | Ultra N-Geneous HDL Calibrator from Genzyme (K021316) | | | | |
| Device description | ELITech Clinical Systems CHOLESTEROL HDL 2G CALIBRATOR is a
lyophilized calibrator based on human serum containing lipoprotein from the
various lipoprotein classes including high density lipoproteins and sodium
azide as preservative.
CHOLESTEROL HDL 2G CALIBRATOR 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. | | | | |
| Intended Use | ELITech Clinical Systems CHOLESTEROL HDL 2G CALIBRATOR is a
calibrator for in vitro diagnostic use in the calibration of quantitative ELITech
Clinical Systems CHOLESTEROL HDL SL 2G on ELITech Clinical Systems
Selectra analyzers. | | | | |

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

SECTION 5 - 510(k) Summary ELITech Clinical Systems CHOLESTEROL LDL SL 2G

| 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. | | ELITech Clinical Systems Device
CHOLESTEROL LDL SL 2G | Predicate device
(ABX PENTRA LDL DIRECT CP) |
|----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The assigned 510(k) number is: K103747 | Intended use | Intended for use with ELITech
Clinical Systems CHOLESTEROL
LDL 2G CALIBRATOR and
ELITech Clinical Systems ELITROL
I and ELITROL II for the
quantitative in vitro diagnostic
determination of Low Density
Lipoprotein (LDL) Cholesterol in
human serum and plasma on
ELITech Clinical Systems Selectra
analyzers. It is not intended for use
in Point of Care settings. | For quantitative in vitro
determination of Low Density
Lipoprotein Cholesterol (LDL-C) in
serum or plasma by colorimetry. |
| Submitter
Address
Phone number
Fax number | SEPPIM S.A.S.
Zone Industrielle, 61500 SEES, FRANCE

33 (0)2 33 81 21 00
33 (0)2 33 28 77 51 | Indication(s) for Use | Intended to measure Low Density
Lipoprotein (LDL) Cholesterol in
human serum and plasma.
Lipoprotein measurements are
used in the diagnosis and treatment
of lipid disorders (such as diabetes
mellitus), atherosclerosis, and
various liver and renal diseases. | Intended to measure Low Density
Lipoprotein (LDL) Cholesterol in
human serum and plasma. Lipopro-
tein measurements are used in the
diagnosis and treatment of lipid
disorders (such as diabetes melli-
tus), atherosclerosis, and various
liver and renal diseases. |
| Contact | Valérie GOURDON (Email: v.gourdon@elitechgroup.com) | Assay protocol | Enzymatic colorimetric test with
selective detergent | Enzymatic colorimetric test with
selective detergent |
| Date of Preparation | November, 23rd, 2010 | Composition | Reagent R1:
MES buffer ,pH 6.3 ;
Detergent 1 in vitro diagnostic use in the
calibration of quantitative ELITech
Clinical Systems CHOLESTEROL
LDL SL 2G on ELITech Clinical
Systems Selectra analyzers. | For the calibration of Ultra N-
Genous LDL Cholesterol assay in
serum or plasma. |
| Format | Lyophilized calibrator based
on
human serum on human serum
containing lipoprotein from the
various lipoprotein classes
including low density lipoproteins.
This calibrator contains sodium
azide as preservative. | Lyophilized calibrator based
on
human serum on human serum
containing lipoprotein from the
various lipoprotein classes
including low density lipoproteins.
This calibrator contains sodium
azide as preservative |
| Level | Single level | Single level |
| Handling | Carefully open the vial, avoiding the
loss of lyophilizate, and pipette in
exactly 1 mL of distilled/deionized
water. Carefully close the vial and
dissolve the content by successive
swirling. Wait for around 5 minutes
until the complete dissolution and
homogenize again. Do not shake
strongly to avoid formation of foam. | Reconstitute by adding 1 mL of
distilled or deionized water. Close
the vial and let stand for 5 minutes.
Dissolve the contents of the vial by
swirling gently to avoid the
formation of foam. Do not shake. |
| Stability | Lyophilized:
To store at 2-8 °C and protected
from light until the expiry date

After reconstitution, the stabilities
are:

14 days between 2 - 8 °C.
4 weeks at less than -80 °C
(frozen only once) | Lyophilized:
To store at 2-8 °C and protected
from light until the expiry date

After reconstitution, the stabilities
are:

2 weeks at 2 - 8 °C.
the reconstituted calibrator may be
aliquoted and stored at -80 °C. |

Conclusion

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

SECTION 5 - 510(k) Summary –
ELITech Clinical Systems ELITROL I and ELITROL II
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.
	The assigned 510(k) number is: K103747
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: v.gourdon@elitechgroup.com)
Date of Preparation	November, 23rd, 2010
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	JJX- 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 & 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	Predicate Device
	ELITROL I / ELITROL II	Roche Precinorm U / Precipath U
Intended use	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.	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 lyophilate, 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 lyophilate, 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 :

12 hours between 15-25 °C.
5 days between 2-8 °C.
4 weeks between -25 and -15 °C
(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 |

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.

Image /page/13/Picture/13 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular text element and an emblem. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion. The emblem is a stylized depiction of an eagle or bird with its wings spread, facing right.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

ELITech SEPPIM S.A.S. c/o Debra K Hutson 21720 236d Dr SE. Suite 150 Bothell. WA 98021

MJG 3 1 2011

Rc: K103747

Trade/Device Name:

ELITech Clinical Systems CHOLESTEROL HDL SL 2G, ELITech Clinical Systems CHOLESTEROL HDL 2G CALIBRATOR, ELITech Clinical Systems CHOLESTEROL LDL SL 2G, .ELITech Clinical Systems CHOLESTEROL LDL 2G CALIBRATOR, and ELITech Clinical Systems ELITROL I and ELITROL II Regulation Number: 21 CFR 862.1475 Regulation Name: LDL & VLDL Precipitation, Cholesterol Via Esterase-Oxidase, HDL Regulatory Class: Class 1, meets limitations per 21 CFR 862.9(c)(4) Product Codes: LBS, JIT, JJY, MRR Dated: August 25, 2011 Received: August 30. 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 class II (Special Controls), 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 manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Virro Diagnostic Device, Evaluation 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 Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding 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 (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

signature

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

Indications for Use Form

510(k) Number (if known): K103747

ELITech Clinical Systems CHOLESTEROL HDL SL 2G Device Name: ELITech Clinical Systems CHOLESTEROL HDL 2G CALIBRATOR

Indications for Use:

Reagent:

Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

Calibrator

ELITech Clinical Systems CHOLESTEROL HDL 2G CALIBRATOR is a calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems CHOLESTEROL HDL SL 2G on the ELITech Clinical Systems Selectra analyzers.

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)

Rute Chalon

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

510(k) K103747

Indications for Use Form

510(k) Number (if known): _K103747

ELITech Clinical Systems CHOLESTEROL LDL SL 2G Device Name: ELITech Clinical Systems CHOLESTEROL LDL 2G CALIBRATOR

Indications for Use:

Reagent:

ELITech Clinical Systems CHOLESTEROL LDL SL 2G is intended for use with ELITech Clinical Systems CHOLESTEROL LDL 2G CALIBRATOR and ELITech Clinical Systems ELITROL I and ELITROL II for the quantitative in vitro diagnostic determination of Low Density Lipoprotein (LDL) Cholesterol in human serum and plasma on ELITech Clinical Systems Selectra analyzers. It is not intended for use in Point of Care settings.

Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

Calibrator:

ELITech Clinical Systems CHOLESTEROL LDL 2G CALIBRATOR is a calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems CHOLESTEROL LDL SL 2G on ELITech Clinical Systems Selectra Analyzers.

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)

Rute Anslen

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

510(k) K103747

Indications for Use Form

510(k) Number (if known): K103747

Device Name:

Indications for Use:

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.

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)

Rute charlier

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

510(k) 103747 .

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