(143 days)
No
The description focuses on the principle of capillary electrophoresis and does not mention any AI or ML components.
No
This device is for in vitro diagnostic use, specifically for analysis of blood samples to monitor long-term glycemic control, not for therapy.
Yes
The device is described as "For In Vitro Diagnostic Use" and its function is to measure hemoglobin A1c to monitor long-term glycemic control in individuals with diabetes mellitus, which directly supports diagnosis and monitoring of a medical condition.
No
The device description clearly details a physical instrument (CAPILLARYS 2 FLEX-PIERCING) that performs capillary electrophoresis on blood samples. The software is part of a larger hardware system.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "For In Vitro Diagnostic Use." This is the most direct confirmation.
- Intended Use: The device is designed for the "separation and quantification of the HbA1c glycated fraction of hemoglobin in human blood." This is a diagnostic test performed on a biological sample (blood) outside of the body (in vitro).
- Purpose: The measurement of HbA1c is used for "monitoring long-term glycemic control in individuals with diabetes mellitus," which is a diagnostic and monitoring purpose related to a medical condition.
- Components: The kit includes calibrators and controls, which are standard components of IVD assays used for ensuring accuracy and quality control of the diagnostic test.
- Setting and User: The device is intended for "laboratory use" and "Professional Use Only," which are typical characteristics of IVD devices used in clinical or diagnostic settings.
N/A
Intended Use / Indications for Use
The CAPILLARYS Hb A1c kit is designed for separation and quantification of the HbA1c glycated fraction of hemoglobin in human blood, by capillary electrophoresis in alkaline buffer (pH 9.4) with the CAPILLARYS 2 FLEX-PIERCING instrument. The CAPILLARYS Hb A1c kit is designed for laboratory use. Measurement of the hemoglobin A1c is effective in monitoring long-term glycemic control in individuals with diabetes mellitus. The CAPILLARYS Hb A1c kit is designed for Professional Use Only. For In Vitro Diagnostic Use.
The Hb A1c CAPILLARY Calibrators are designed for the calibration and migration control of human glycated hemoglobin A1c with the SEBIA CAPILLARYS Hb A1c electrophoresis procedure performed with the CAPILLARYS 2 FLEX-PIERCING automated instrument for capillary electrophoresis. The Hb A1c CAPILLARY Calibrators are designed for Professional Use Only.
The Hb A1c CAPILLARY Controls are designed for the quality control of human glycated hemoglobin A1c quantification with CAPILLARYS Hb A1c electrophoresis procedure performed with the CAPILLARYS 2 FLEX-PIERCING automated instrument for capillary electrophoresis. The Hb A1c CAPILLARY Controls are designed for Professional Use Only. For In Vitro Diagnostic Use.
Product codes (comma separated list FDA assigned to the subject device)
LCP, JIS, JJX
Device Description
The CAPILLARYS Hb A1c kit is designed for separation and quantification of the HbA1c glycated fraction of hemoglobin in human blood. It uses capillary electrophoresis in an alkaline buffer (pH 9.4) with the CAPILLARYS 2 FLEX-PIERCING instrument. The kit includes Buffer, Hemolysing solution, Wash solution, Green Dilution segments, and Filters.
The CAPILLARYS HbA1c Calibrators (PN 4755) consist of two levels (Calibrator 1 and Calibrator 2) supplied as lyophilized vials, each with a barcode label.
The CAPILLARYS HbA1c Controls (PN 4744) consist of two levels (Control 1 and Control 2) supplied as lyophilized vials. Barcode labels and white/grey dilution segments are also supplied.
Required but not supplied items include CAPICLEAN, CAPILLARYS / MINICAP Wash Solution, Boxes for control storage, Tubes and caps for controls, Wedge adapters, PHORESIS software, and the CAPILLARYS 2 FLEX-PIERCING INSTRUMENT (PN 1227).
The CAPILLARYS 2 FLEX-PIERCING instrument employs free solution capillary electrophoresis (FSCE), separating proteins in an alkaline buffer according to their charge, electrolyte pH, and electroosmotic flow. It has 8 parallel silica capillaries for simultaneous analyses and performs direct detection of hemoglobins at 415 nm. The instrument includes automated sample hemolysis and continuous sample loading using sample racks. The system is controlled via a PC interface and uses SEBIA PHORESIS software.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Human whole blood
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professional Use Only / Laboratory Use
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)
The performance and comparative studies of the CAPILLARYS Hb A1c test performed with the CAPILLARYS 2 FLEX-PIERCING system were performed using SEBIA's commercially available materials and standard procedures. In comparative studies, commercially available materials and standard procedures were used with the predicate device: TOSOH G8 Automated Glycohemoglobin Analyzer HLC-723G8 (K071132). The SEBIA CAPILLARYS Hb A1c procedure, performed with the CAPILLARYS 2 FLEX-PIERCING system, was found to be substantially equivalent in function, use, safety, effectiveness, and performance to the predicate devices. Analysis throughput for the subject device is 40 analyses / hour, compared to 37 analyses / hour for the predicate.
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.
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.
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
§ 864.7470 Glycosylated hemoglobin assay.
(a)
Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image contains a handwritten word "K122101". The word starts with a capital letter K, followed by the number 1, then two 2's, then the number 1 again, then the number 0, and ends with the number 1. The handwriting is simple and clear.
6 2012 DEC
510(k) SUMMARY 1.
INTENDED USE AND SUMMARY OF THE PROCEDURES
The CAPILLARYS Hb A1c kit is designed for separation and quantification of the HbA1c glycated fraction of hemoglobin in human blood, by capillary electrophoresis in alkaline buffer (pH 9.4) with the CAPILLARYS 2 FLEX-PIERCING instrument. The CAPILLARYS Hb A1c kit is designed for laboratory use. Measurement of the hemoglobin A1c is effective in monitoring long-term glycemic control in individuals with diabetes mellitus. The CAPILLARYS Hb A1c kit is designed for Professional Use Only.
For In Vitro Diagnostic Use.
The CAPILLARYS Hb A1c procedure performed with the CAPILLARYS 2 FLEX-PIERCING instrument has been certified by the National Glycohemoglobin Standardization Program (NGSP).
Electrophoresis is a well established technique routinely used in clinical laboratories for measuring components from body fluids, including HbA1c glycated fraction. The CAPILLARYS 2 FLEX-PIERCING instrument has been developed to provide complete automation of this testing with fast separation and good resolution. In many aspects, the methodology can be considered as an intermediary type of technique between classical zone electrophoresis and liquid chromatography.
The CAPILLARYS 2 FLEX-PIERCING instrument uses the principle of capillary electrophoresis in free solution. With this technique, charged molecules are separated by their electrophoretic mobility in an alkaline buffer with a specific pH. Separation also occurs according to the electrolyte pH and electroosmotic flow.
The CAPILLARYS 2 FLEX-PIERCING instrument has silica capillaries functioning in parallel allowing 8 simultaneous analyses for HbA1c quantification from whole blood sample. A sample dilution with hemolysing solution is prepared and injected by aspiration at the anodic end of the capillary. A high voltage protein separation is then performed and direct detection of the hemoglobins is made at the cathodic end of the capillary at 415 nm, which is the absorbance wave length specific to hemoglobins. Before each run, the capillaries are washed with a wash solution and prepared for the next analysis with buffer.
Direct detection provides accurate relative quantification of individual hemoglobin Arefraction. In addition, the high resolution of CAPILLARYS Hb A1c procedure allows the quantification of HbArc, even in the presence of labile HbAxe, carbamylated hemoglobins, major hemoglobin variants such as HbS, HbC, HbD, HbE and HbF and common interfering factors such as Trialycerides, Bilirubin, Ascorbic Acid, Urea, Rheumatoid factor, and Glybenclamide as outlined in the package insert labeling.
By using alkaline pH buffer, normal and abnormal (or variant) hemoglobins are detected in the following order, from cathode to anode : A2/C, E, S/D, F, A0, other Hb (including minor Hb A1) and then A1c.
1
SUBJECTS OF THIS 510(K) PREMARKET NOTIFICATION
This submission is limited to the CAPILLARYS Hb A1c procedure (PN 2015). CAPILARYS Hb A1c calibrators (PN 4755) and CAPILLARYS HbA1c control (PN 4744) performed with the SEBIA CAPILLARYS 2 FLEX-PIERCING instrument (PN 1227).
CAPILLARYS 2 FLEX-PIERCING is a capillary electrophoresis instrument that has been previously cleared for CAPILLARYS HEMOGLOBIN(e) assay under K112550, issued on May 25th, 2012.
REGULATORY STATUS
The CAPILLARYS Hb A1c types of devices/assays are classified by FDA as Class II, under Requlation No. 21 CFR 864.7470, SEBIA is seeking clearance to import the assay described above, and by this submission is notifying FDA of its intent to market these products in the United States.
PRODUCT DESCRIPTION
1. Reagent Kit
The CAPILLARYS HbA1c kits, controls and calibrators are used with the CAPILLARYS 2 FLEX-PIERCING system.
The configurations of the components are summarized:
- . CAPILLARYS HbA1c kits in Table I.
- CAPILLARYS HbA1c Calibrators in Table II. .
- CAPILLARYS HbA1c controls in Table III. .
- Reagents that are required to perform the test but are sold separately in Table IV .
For additional details, see Package Inserts included in Section III, Attachment III C. Each kit, control and calibrators is supplied with Package Insert which contains instruction for use and all the necessary information on the reagents needed to run the tests. Each Package Insert also contains information on storage conditions, shelf life and signs of deterioration of the components and the reagents sold separately.
TABLE I. REAGENTS AND MATERIALS SUPPLIED IN THE CAPILLARYS HbA1c KIT (Р№ 2015)
| ITEMS | PN 2015 |
|---|---|
| Buffer (ready to use) | 2 vials, 700 mL each |
| Hemolysing solution (ready to use) | 1 vial, 700 mL |
| Wash solution (stock solution) | 1 vial, 75 mL |
| Green Dilution segments | 1 pack of 90 |
| Filters | 4 filters |
2
.
MATERIALS SUPPLIED WITH CAPILLARYS HbA1c TABLE II. REAGENTS AND CALIBRATORS (PN 4755)
| ITEMS | PN 4755 |
|---|---|
| Hb A1c CAPILLARYS Calibrator 1 (green cap) | 1 vial of each, 600µL each |
| Hb A1c CAPILLARYS Calibrator 2 (red cap) | 1 |
| Barcode label HbA1c CAPILLARYS Calibrator 1 | 1 |
| Barcode label HbA1c CAPILLARYS Calibrator 2 | 1 |
TABLE III. REAGENTS AND MATERIALS SUPPLIED WITH CAPILLARYS HbA1c CONTROLS (PN 4744)
| ITEMS | PN 4744 |
|---|---|
| HbA1c CAPILLARYS Control 1 ( white cap ) | 1 vial of each, 600µL each |
| HbA1c CAPILLARYS Control 2 ( black cap ) | 1 vial of each, 600µL each |
| Barcode label HbA1c CAPILLARYS Control 1 | 2 |
| Barcode label HbA1c CAPILLARYS Control 2 | 2 |
| White Dilution segments for Control 1 | 4 |
| Grey Dilution segments for Control 2 | 4 |
TABLE IV. REAGENTS AND MATERIALS REQUIRED BUT NOT SUPPLIED IN THE CAPILLARYS HbA1c KIT, CONTROLS OR CALIBRATORS
| ITEMS | PN | COMPONENTS |
|---|---|---|
| CAPICLEAN | 2058 | 1 vial, 25 mL |
| CAPILLARYS / MINICAP Wash | ||
| Solution | 2052 | 2 vials, 75 mL |
| Boxes for control storage | 2082 | 2 boxes |
| Tubes and caps for controls | 9205 | 500 per box |
| Wedge adapters | 9203 | 10 per box |
| PHORESIS software | 1110 | |
| CAPILLARYS 2 FLEX-PIERCING | ||
| INSTRUMENT | 1227 |
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2. Accessories Required but Sold Separately
The accessory required for the CAPILLARYS HbA1c kit for the automated procedure has been identified in the preceding paragraphs. It is:
CAPILLARYS 2 FLEX-PIERCING automated capillary electrophoresis system, which is part of the 510(K) premarket notification "CAPILLARYS HEMOGLOBIN(e)", K112550, for which FDA clearance was issued May 25th, 2012.
LABELING
Proposed labeling is described in Section III.
COMPARISON (CONCORDANCE), SUBSTANTIAL EQUIVALENCE AND PERFORMANCE STUDIES
The performance and comparative studies of the CAPILLARYS Hb A1c test performed with the CAPILLARYS 2 FLEX-PIERCING system were performed using SEBIA's commercially available materials and standard procedures.
Similarly, in comparative studies, commercially available materials and standard procedures were used with the predicate device: TOSOH G8 Automated Glycohemoglobin Analyzer HLC-723G8 (K071132), which are based on high performance liquid chromatography (HPLC) of blood samples for Hb A1c analvsis.
The SEBIA CAPILLARYS Hb A1c procedure, performed with the CAPILLARYS 2 FLEX-PIERCING system were found to be substantially equivalent in function, use, safety, effectiveness and the performance to predicate devices described above.
The following tables presents the similarities and the differences between the SEBIA CAPILLARYS Hb A1c test, calibrators and controls performed with the CAPILLARYS 2 FLEX-PIERCING as compared to the TOSOH G8 automated divcohemoglobin analyzer HLC-723G8 (K071132) both used for qualitative and quantitative analysis of Hb A1c .
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| TOSOH G8 AUTOMATED
GLYCOHEMOGLOBIN ANALYZER
HLC-723G8 (K071132) | SEBIA CAPILLARYS Hb A1c technique
with CAPILLARYS 2 FLEX-PIERCING
instrument | |
|-----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The G8 Automated Glycohemoglobin
Analyzer HLC-723G8 is intended for In
Vitro Diagnostic Use for the
measurement of hemoglobin A1c
(HbA1c) in whole blood specimens. Hb
A1c measurements are used in the
clinical management of diabetes to
assess the long-term efficacy of diabetic
control. | The CAPILLARYS Hb A1c kit is designed
for separation and quantification of the
HbA1c glycated fraction of hemoglobin in
human whole blood, by capillary
electrophoresis in alkaline buffer (pH 9.4)
with the CAPILLARYS 2 FLEX-PIERCING
instrument. Measurement of hemoglobin
A1c is effective in monitoring long-term
glycemic control in individuals with
diabetes mellitus. The CAPILLARYS Hb
A1c kit is designed for Professional Use
Only.
For In Vitro Diagnostic Use. |
| Separation
System | Ion-exchange high performance liquid
chromatography (HPLC): protein
separation on the column based on their
ionic interactions with the cartridge
material and elution by buffer gradient
with increasing ionic
strength. Chromatograms show retention
times of eluted fractions. | Free solution capillary electrophoresis
(FSCE): protein separation in an alkaline
buffer (pH 9.4) according to their charge, to
the electrolyte pH and electroosmotic flow.
Fast separation and good resolution.
Electrophoregrams show separated
fractions according to their charge. |
| Instrument | TOSOH G8 instrument
Image: TOSOH G8 instrument | SEBIA CAPILLARYS 2 FLEX-PIERCING
instrument, PN 1227
Image: SEBIA CAPILLARYS 2 FLEX-PIERCING instrument |
| Interface | Touch screen interface | PC interface |
| | TOSOH G8 AUTOMATED
GLYCOHEMOGLOBIN ANALYZER
HLC-723G8 (K071132) | SEBIA CAPILLARYS Hb A1c technique
with CAPILLARYS 2 FLEX-PIERCING
instrument |
| Absorbance
wave length | 415 and 510 nm | 415 nm |
| Software | Tosoh Piano EVO3 software | SEBIA PHORESIS™ software |
| Number of
separation units | 1 column | 8 parallel capillaries (total capillaries on
CAPILLARYS 2 FLEX-PIERCING
instrument: 8 capillaries) |
| Calibration | Yes | Yes |
| Sample type | Whole blood in capped tube | Whole blood in capped tube |
| Samples
identification | Yes (Bar code on sample tube) | Yes (Bar code reading on both sample racks
and tubes) |
| Hemolysis | Performed automatically by the system | Performed automatically by the instrument |
| Introduction of
the samples into
the automatic
system | Continuous loading | Continuous loading using sample racks |
| Analysis
throughput | 37 analyses / hour | 40 analyses / hour |
| Collection tubes | Tubes with EDTA anticoagulant | Tubes with EDTA anticoagulant |
| Reagent | G8 Variant Elution Buffer Hsi
HbA1c Calibrator set
Hemoglobin A1c Control
TSKgel G8 Variant Hsi
Hsi Hemolysis & Wash Solution | CAPILLARYS Hb A1c Kit :
Buffer
Hemolyzing solution
Wash solution
Dilution segments
Filters
CAPILLARYS Hb A1c CALIBRATORS:
CAPILLARYS Hb A1c Calibrator 1
CAPILLARYS Hb A1c Calibrator 2
CAPILLARYS Hb A1c CONTROLS :
CAPILLARYS Hb A1c Control 1
CAPILLARYS Hb A1c Control 2 |
| Standartization | NGSP
IFCC | NGSP
IFCC |
| | TOSOH
Hemoglobin A1c Calibrator Set
K071132 | SEBIA
HbA1c CAPILLARY CALIBRATORS |
| Intended Use | The Hemoglobin A1c Calibrator Set is a
reference agent designed for calibrating the
Tosoh Automated Glycohemoglobin
Analyzer HCL-723G8. | The Hb A1c CAPILLARY Calibrators are
designed for the calibration and migration
control of human glycated hemoglobin A1c
with the SEBIA CAPILLARYS Hb A1c
electrophoresis procedure performed with the
CAPILLARYS 2 FLEX-PIERCING automated
instrument for capillary electrophoresis.
For In Vitro Diagnostic Use. |
| Format | 2 levels
5 vials (4 mL) per level | 2 levels
1 vial (0.6 mL) per level |
| Preparation | Reconstitute calibrators (1) and (2) by
adding 4 mL of distilled water to each. | Reconstitute each lyophilized calibrator vial
with 0.6 mL of distilled or deionized water. |
| Storage
temperature | The Hemoglobin A1c Calibrator set should
be stored at 2 to 8 °C while unopened. It will
remain stable for use up to the expiration
date listed on the vial. | Before reconstitution, the lyophilized
calibrators must be stored between - 30 °C
and - 18 °C. They are stable until the
expiration date indicated on the vial labels. |
| In use storage | After being opened, the hemoglobin A1c
Calibrator Set will remain stable for use for
up to one week at 2 to 8°C. | After reconstitution, store the calibrators at 2 -
8 °C in a closed conical tube for control blood
and use them within the day (for 8 hours
maximum). After use, they must be stored
without any delay between - 18 °C and - 22
°C due to the risk of microbial contamination
and denaturation. They are stable for 6
months maximum between - 18 °C and -
22 °C.
Do not freeze and thaw the reconstituted
calibrators more than 3 times. |
| Traceability | The assigned values are traceable to IFCC. | Same |
| Instrument | Tosoh Automated Glycohemoglobin
Analyzer HCL-723G8 | SEBIA CAPILLARYS 2 FLEX-PIERCING |
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6
: ・
The predicate device for the Hb A1c CAPILLARY calibrators is the Tosoh Hemoglobin A1c calibrators, it has been FDA cleared (K071132).
7
The predicate device for the Hb A1c CAPILLARY controls is Tosoh Hemoglobin A1c Controls, it has been FDA cleared by the manufacturer Canterbury Scientific under (K021484).
| | TOSOH
Hemoglobin A1c Controls
K021484 | SEBIA
HbA1c CAPILLARY CONTROLS |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Hemoglobin A1c Control are intended
for use as quality control materials to monitor
the precision of laboratory testing
procedures for HbA1c quantitation. The
controls are designed for use with Tosoh
Bioscience, Inc G7and G8 analyzers. | The Hb A1c CAPILLARY Controls are
designed for the quality control of human
glycated hemoglobin A1c quantification with
CAPILLARYS Hb A1c electrophoresis
procedure performed with the CAPILLARYS 2
FLEX-PIERCING automated instrument for
capillary electrophoresis. The HbA1c
CAPILLARYS Controls are designed for
Professional Use Only. |
| | | For In Vitro Diagnostic Use. |
| Format | 2 levels
4 vials (0.25 mL) per level | 2 levels
1 vial (0.6 mL) per level |
| Preparation | Each vial must be reconstituted with 250 µL
of reagent grade type I water. | Reconstitute each lyophilized control vial with
0.6 mL of distilled or deionized water. |
| Storage
temperature | Hemoglobin A1c controls are stable until the
last day of the expiration date shown on the
vial when stored unopened at 2 - 8°C. | Before reconstitution, the lyophilized controls
must be stored refrigerated (2 to 8 °C). They
are stable until the expiration date indicated
on the vial labels. |
| In use storage | Once the control is reconstituted it can be
used for 60 days when stored tightly capped
at 2-8°C. The reconstituted control should
not be stored uncapped. Aliquots can be
frozen at -15°C for up to 4-6 months (no
multiple thawing and re-freezing). Diluted
controls should not be frozen. | After reconstitution, store the controls at 2 - 8
°C in a closed conical tube for control blood
and use them within the day (for 8 hours
maximum). After use, they must be stored
without any delay between - 18 °C and - 22
°C due to the risk of microbial contamination
and denaturation. They are stable for 6
months maximum between - 18 °C and -
22 °C.
Do not freeze and thaw the reconstituted
controls more than 30 times.
After hemolysis with the CAPILLARYS 2
FLEX-PIERCING instrument, store the
dilution segments with controls at 2 - 8 °C and
use them within the day (for 8 hours
maximum). They may be stored, without any
delay, between - 18 °C and - 22 °C for 1
month maximum. Do not freeze and thaw a
dilution segment with hemolyzed control more
than three times. |
| Instrument | Tosoh
Automated
Analyzer HCL-723G8
Glycohemoglobin | SEBIA CAPILLARYS 2 FLEX-PIERCING |
8
STANDARDS
CAPILLARYS Hb A1c test is standardized according to NGSP and IFCC requirements/guidelines (Section VII).
STATEMENT OF MANUFACTURE AND MANUFACTURING CONTROLS
The CAPILLARYS Hb A1c kits and accessories are manufactured by SEBIA in accordance with applicable GLP and GMP / Quality System practices and SEBIA's own specifications, in their entirety at its manufacturing facility located at:
Parc Technologique Léonard de Vinci, Rue Léonard de Vinci CP 8010 LISSES 91008 EVRY Cedex, FRANCE
All raw materials are obtained by SEBIA from qualified suppliers.
SEBIA adheres to a system of incoming, in process and finished product quality control procedures.
The manufacturing and quality control procedures are documented in Section VI of this 510(K) submission.
SEBIA has been certified against ISO 9001 / ISO 13485.
The CAPILLARYS Hb A1c devices are for In Vitro Diagnostic Use.
SEBIA's corporate office is located at:
Parc Technologique Léonard de Vinci, Rue Léonard de Vinci CP 8010 LISSES 91008 EVRY Cedex, FRANCE
Phone: (33) 1 69 89 80 80 : Fax: (33) 1 69 89 78 78
In the United States, the product will be distributed by:
SEBIA Inc. Suite 400 - 1705 Corporate drive NORCROSS GA 30093, USA
Phone 770 446 - 3707 ; Fax 770 446 - 8511
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Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring three curved lines that resemble a caduceus or a stylized representation of human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
December 6, 2012
SEBIA c/o Karen Anderson 1705 Corporate Drive Suite 400 Duluth, Georgia 30093
Re: K122101
Trade/Device Name: CAPILLARYS Hb Alc Kit, Hb Alc CAPILLARY Calibrators Hb Alc CAPILLARY Controls
Regulation Number: 21 CFR §864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: LCP, JIS, JJX Dated: November 19, 2012 Received: November 20, 2012
Dear Ms. Anderson:
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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
10
Page 2 - Karen Anderson
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 Diagnostics and Radiological Health at (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Carol C. Benson for
Courtney H. Lias, Ph.D. Director
Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
11
Indications for Use
510(k) Number (if known): K | ZZ10|
Device Name: CAPILLARYS Hb A1c using the CAPILLARYS 2 FLEX-PIERCING instrument
Indications for Use:
The CAPILLARYS Hb Alc kit is designed for separation and quantification of the glycated fraction of hemoglobin in human whole blood, by capillary HbAic electrophoresis in alkaline buffer (pH 9.4) with the CAPILARYS 2 FLEX-PIERCING instrument. Measurement of hemoglobin A10 is effective in monitoring long-term glycemic control in individuals with diabetes mellitus. The CAPILLARYS Hb Alc kit is designed for Professional Use Only.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Kattlus sust
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) L122101
Page 1 of
12
Indications for Use
510(k) Number (if known): K(ZZ10 |
Device Name: Hb A1c CAPILLARY CALIBRATORS using the CAPILLARYS 2 FLEX-PIERCING instrument
Indications for Use:
The Hb Alc CAPILLARY Calibrators are designed for the calibration and migration control of human glycated hemoglobin Are quantification with SEBIA CAPILLARYS Hb Alc electrophoresis procedure performed with the CAPILLARYS 2 FLEX-PIERCING automated instrument for capillary electrophoresis. The Hb Alc CAPILLARY Calibrators are designed for Professional Use Only.
Prescription Use _ X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Division Sign-Off
Office of In Vitro Blagnostics and Radiological Health
16122101 510(k)
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Indications for Use
510(k) Number (if known): K12-Z101
Device Name: Hb A1c CAPILLARY CONTROLS using the CAPILLARYS 2 FLEX-PIERCING instrument
Indications for Use:
The Hb Alc CAPILLARY Controls are designed for the quality control of human glycated hemoglobin Are quantification with CAPILLARYS Hb Alc electrophoresis grocedure performed with the CAPILLARYS 2 FLEX-PIERCING automated instrument for capillary electrophoresis. The Hb Alc CAPILLARY Controls are designed for Professional Use Only.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use _ (21 CFR Part 801 Subpart C)
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Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Patlu Sinius
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) K122101
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