(150 days)
The CAPILLARYS IMMUNOTYPING kit is designed for the detection and the characterization of monoclonal proteins (immunotyping) in human urine and serum with the CAPILLARYS, the CAPILLARYS 2 and the CAPILLARYS 2 FLEX-PIERCING, SEBIA, for capillary electrophoresis. It is used in conjunction with the SEBIA CAPILLARYS PROTEIN(E) 6 kit designed for proteins separation into 6 major fractions in alkaline buffer (pH 9.9).
The CAPILLARYS, CAPILLARYS 2 and the CAPILLARYS 2 FLEX-PIERCING perform all procedural sequences automatically to obtain a protein profile for qualitative analysis. Each urine or serum sample is mixed with individual antisera that are specific against gamma (Ig G), alpha (Ig A) and mu (Ig M) heavy chains, and kappa (free and bound) light chains and lambda (free and bound) light chains, respectively .
The proteins, separated in silica capillaries, are directly detected by their absorbance at 200 nm.
The electrophoregrams are evaluated visually to detect the presence of specific reactions with the suspect monoclonal proteins.
For In Vitro Diagnostic Use.
The IT / IF Control is designed to quality control the qualitative the detection and characterization of human monoclonal immunoglobulins (Ig G, Ig A, Ig M, Kappa and Lambda) with the electrophoresis methods:
- Immunotyping performed using capillary electrophoresis on SEBIA CAPILLARYS 2 and CAPILLARYS 2 FLEX PIERCING instruments and on SEBIA MINICAP instrument.
- Immunofixation methods: SEBIA HYDRAGEL IF, HYDRAGEL IF Penta, . HYDRAGEL BENCE JONES (Standard mask and Dynamic mask) performed using the HYDRASYS and HYDRASYS 2 instruments and the K20 electrophoresis chamber.
The IT / IF Control is designed for laboratory use. It should be used (with its barcode label for CAPILLARYS and MINICAP procedures) like a human serum sample. The electrophoretic pattern obtained is specific for each batch of IT/IF control.
For In Vitro Diagnostic Use.
This submission includes:
-
- CAPILLARYS IMMUNOTYPING (PN 2100) with the device CAPILLARYS 2 instrument (PN 1222) for serum and urine samples. The CAPILLARYS IMMUNOTYPING KIT was cleared in prior 510K submissions.
-
- IT / IF Control (PN 4788) with the new device CAPILLARYS 2 instrument (PN 1222). The IT / IF Control was cleared in prior 510K submissions.
-
- CAPILLARYS IMMUNOTYPING (PN 2100) with the device CAPILLARYS 2 FLEX PIERCING instrument (PN 1227) for serum and urine samples. The CAPILLARYS IMMUNOTYPING KIT was cleared in prior 510K submissions
The configurations of the CAPILLARYS IMMUNOTYPING kits consist of the components summarized in Tables I and II. Additional details are provided in Package Inserts included in Section III of the submission. Each kit with instrument is supplied with Package Insert/manual which contains instruction for use and all the necessary information on the components needed to run the test that are sold separately. Each Package insert also contains information on storage conditions, shelf-life and signs of deterioration of the kit components and the reagents sold separately.
The provided document describes a 510(k) premarket notification for "CAPILLARYS IMMUNOTYPING" and "IT / IF CONTROL" systems. It focuses on demonstrating the substantial equivalence of these systems when used with the CAPILLARYS 2 and CAPILLARYS 2 FLEX PIERCING instruments to previously cleared predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define quantitative acceptance criteria for device performance in terms of metrics like sensitivity, specificity, or accuracy. Instead, the "acceptance criteria" for this 510(k) submission are based on demonstrating "substantial equivalence" to predicate devices. The reported device performance is presented in terms of this equivalence across various aspects.
| Acceptance Criterion (Demonstrating Substantial Equivalence) | Reported Device Performance (Summary) |
|---|---|
| CAPILLARYS IMMUNOTYPING Kit with CAPILLARYS 2 Instrument vs. Predicate Device (Sebia HYDRAGEL IF kit, K960669) | Found "substantially equivalent in assay principle, function, use, safety and effectiveness" for serum and urine specimens. This implies comparable qualitative analysis for detection and characterization of monoclonal proteins. |
| IT/IF Control with CAPILLARYS 2 Instrument vs. Predicate Device (Paragon CZE 2000 IFE/s Control, K002799) | Found "substantially equivalent in assay, principal, function, use, safety and effectiveness." This indicates comparable quality control performance for detection and characterization of human monoclonal immunoglobulins. |
| CAPILLARYS IMMUNOTYPING Kit with CAPILLARYS 2 Instrument vs. CAPILLARYS 2 FLEX PIERCING Instrument | Found "substantially equivalent in assay, principle, function, use and safety and effectiveness" for serum and urine samples. This demonstrates equivalence between the two instruments when performing immunotyping. |
2. Sample Size Used for the Test Set and Data Provenance
The document provides limited specific details on the sample sizes used for the comparative studies.
- "CAPILLARYS IMMUNOTYPING KIT" (reagents): The reagents were previously cleared in K042939 (serum) and K082085 (urine). These prior submissions would contain the detailed sample sizes for the reagent validation. The current submission re-uses these validated reagents with new instruments.
- "IT / IF Control": The control was previously cleared in K101863. Like the reagents, the specific sample sizes for its validation with its original predicate would be in that prior submission. The current submission compares its performance on the CAPILLARYS 2.
The document states that "performance and comparative studies... were performed using Sebia's commercially available materials and standard procedures." It does not specify the country of origin of the data or explicitly state whether the studies were retrospective or prospective, though the nature of comparative studies for substantial equivalence often involves prospective testing with clinical samples or characterized controls.
3. Number of Experts and Qualifications for Ground Truth
The document does not specify the number of experts or their qualifications used to establish ground truth for the test sets. The "electrophoregrams are evaluated visually to detect the presence of specific reactions with the suspect monoclonal proteins," which implies a visual interpretation by trained personnel. Given that these are IVD devices, it is implied that laboratory professionals/medical technologists would be involved in interpretation, but specific qualifications are not detailed in this summary.
4. Adjudication Method for the Test Set
The document does not mention any specific adjudication method (e.g., 2+1, 3+1). The evaluation is described simply as "evaluated visually," suggesting a direct interpretation rather than a multi-reader adjudication process as seen in some imaging studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. This device is an automated electrophoresis system for immunotyping, where the output (electrophoregrams) is visually interpreted. The focus is on the performance of the integrated system (reagent + instrument) compared to existing methods, rather than assessing human reader performance with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance
The device is an automated electrophoretic system that separates and detects proteins. The "electrophoregrams are evaluated visually." This implies that the device provides the raw data, and human interpretation is still part of the diagnostic process. Therefore, a standalone (algorithm only) performance is not directly applicable in the context of this description, as it's not a fully automated diagnostic algorithm without human interaction. The device performs "all procedural sequences automatically to obtain a protein profile for qualitative analysis," but the final "evaluation" is still visual.
7. Type of Ground Truth Used
The ground truth is not explicitly stated as pathology, outcomes data, or expert consensus in this summary. However, given the nature of immunotyping, the ground truth for "detection and characterization of monoclonal proteins" would typically be established by established laboratory methods, often including confirmation by other techniques or clinical correlation. The comparison to predicate devices (Sebia HYDRAGEL IF kit, Paragon CZE 2000 IFE/s Control) implies that the ground truth for the samples used in the study was established by these well-accepted, previously cleared methods.
8. Sample Size for the Training Set
The document does not provide information about a "training set" or its sample size. This submission focuses on demonstrating substantial equivalence of the device and its components to existing, cleared devices. It's likely that any "training" or development data for the underlying technology (e.g., the reagents, instrument algorithms) would have occurred prior to the predicate device clearances (K042939, K082085, K101863) or during the development of the instruments themselves (K112550, K122101 for other assays). This 510(k) is about demonstrating the new combination's equivalence.
9. How the Ground Truth for the Training Set Was Established
As no training set is explicitly discussed in the context of this 510(k) summary, how its ground truth was established is not detailed.
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CAPILLARYS IMMUNOTYPING & CAPILLARYS 2 / CAPILLARYS 2 FLEX PIERCING instrument
IT / IF CONTROL & CAPILLARYS 2
July 2013
510k SUMMARY
JUL 2 6 2013
INTENDED USE AND SUMMARY OF THE IMMUNOTYPING PROCEDURES
The CAPILLARYS IMMUNOTYPING kit is designed for the detection and the characterization of monoclonal proteins (immunotyping) in human urine and serum with the CAPILLARYS 2 and CAPILLARYS 2 FLEX PIERCING instruments, for capillary electrophoresis. It is used in conjunction with the CAPILLARYS PROTEIN(E) 6 kit, SEBIA, designed for proteins separation into 6 major fractions in alkaline buffer (pH 9.9).
The CAPILLARYS 2 and CAPILLARYS 2 FLEX PIERCING instruments performs all procedural sequences automatically to obtain a protein profile for qualitative analysis. Each urine or serum sample is mixed with individual antisera that are specific against gamma
(Ig G), alpha (Ig A) and mu (Ig M) heavy chains, and kappa (free and bound) light chains and lambda (free and bound) light chains, respectively.
The proteins, separated in silica capillaries, are directly detected by their absorbance at 200 nm.
The electrophoregrams are evaluated visually to detect the presence of specific reactions with the suspect monoclonal proteins.
For In Vitro Diagnostic Use.
INTENDED USE AND SUMMARY OF IT/IF CONTROL PROCEDURES
The IT / IF Control is designed to quality control the qualitative the detection and characterization of human monoclonal immunoglobulins (Ig G, Ig A, Ig M, Kappa and Lambda) with the electrophoresis methods:
-
Immunotyping performed using capillary electrophoresis on SEBIA CAPILLARYS 2 and CAPILLARYS 2 FLEX PIERCING instruments and on SEBIA MINICAP instrument.
-
Immunofixation methods: SEBIA HYDRAGEL IF, HYDRAGEL IF Penta. HYDRAGEL BENCE JONES (Standard mask and Dynamic mask) performed using the HYDRASYS and HYDRASYS 2 instruments and the K20 electrophoresis chamber.
The IT / IF Control is designed for laboratory use. It should be used (with its barcode label for CAPILLARYS and MINICAP procedures) like a human serum sample.
The electrophoretic pattern obtained is specific for each batch of IT/IF control.
For In Vitro Diagnostic Use.
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CAPILLARYS IMMUNOTYPING & CAPILLARYS 2 / CAPILLARYS 2 FLEX PIERCING instrument IT / IF CONTROL & CAPILLARYS 2
July 2013
PRINCIPLES OF THE IMMUNOTYPING TEST
The principles of the test of Sebia CAPILLARYS IMMUNOTYPING kit using the CAPILLARYS 2 instrument and CAPILLARYS 2 FLEX PIERCING instrument are described in Section IV in the performance standards of this submission and the test details are presented in the product package insert included with each kit in Section III (labeling).
The Sebia CAPILLARYS IMMUNOTYPING reagent kit was cleared in prior 510K submission, K042939 using serum samples and K082085 using urine samples. Electrophoresis is a process for the identification of monoclonal proteins (M-proteins, paraproteins, monoclonal immunoglobulins) that are detected as abnormal fraction(s) in the serum or urine protein electrophoresis primarily in the beta globulin and gamma globulin zones. Immunotyping procedure allows for specific identification of such immunoglobulin proteins. The proteins migrate through a buffered capillary at a specific pH. Separation occurs according to the electrolyte pH and electroosmotic flow. Specific antisera (IgG, IgA, IgM, Kappa and Lambda) are mixed with the sample. A reference pattern is compared with the patterns obtained after individual immunoglobulin classes and types have been eliminated from the serum or urine sample in reactions with specific antisera.
- A. This submission is to support the use of CAPILLARYS IMMUNOTYPING with the device CAPILLARYS 2 instrument, with serum and urine samples. The reagents CAPILLARYS IMMUNOTYPING were previously cleared in submissions K042939 and K082085.
- B. This submission also includes supporting data for the IT / IF Control with the device CAPILLARYS 2 instrument, using the CAPILLARYS IMMUNOTYPING reagents.
The IT/IF control was cleared in prior 510K submissions, K101863. The results of the IT/IF control using the CAPILLARYS 2 instrument with the CAPILLARYS IMMUNOTYPING procedure was compared to the Beckman Paragon CZE 2000 IFE/s Control which was cleared, K002799
- C. This submission will demonstrate the CAPILLARYS IMMUNOTYPING with the CAPILLARYS 2 instrument compared to the CAPILLARYS 2 FLEX PIERCING instrument, with serum and urine samples. This study presents the equivalence of both instruments (CAPILLARYS 2 and CAPILLARYS 2 FLEX PIERCING).
The reagents CAPILLARYS IMMUNOTYPING were previously cleared in submissions K042939 and K082085.
The CAPILLARYS 2 FLEX PIERCING instrument was 510K cleared, K112550, May 25 2012 for CAPILLARYS HEMOGLOBIN(E). The CAPILLARYS 2 FLEX PIERCING instrument was also 510K cleared, K122101, for CAPILLARYS HbA1c.
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CAPILLARYS IMMUNOTYPING & CAPILLARYS 2 / CAPILLARYS 2 FLEX PIERCING instrument IT / IF CONTROL & CAPILLARYS 2
July 2013
SUBJECTS OF THIS 510(k) PREMARKET NOTIFICATION
This submission includes:
-
- CAPILLARYS IMMUNOTYPING (PN 2100) with the device CAPILLARYS 2 instrument (PN 1222) for serum and urine samples. The CAPILLARYS IMMUNOTYPING KIT was cleared in prior 510K submissions.
-
- IT / IF Control (PN 4788) with the new device CAPILLARYS 2 instrument (PN 1222). The IT / IF Control was cleared in prior 510K submissions.
-
- CAPILLARYS IMMUNOTYPING (PN 2100) with the device CAPILLARYS 2 FLEX PIERCING instrument (PN 1227) for serum and urine samples. The CAPILLARYS IMMUNOTYPING KIT was cleared in prior 510K submissions
REGULATORY STATUS
The CAPILLARYS IMMUNOTYPING and IT / IF CONTROL using the CAPILLARYS 2 Instrument/ CAPILLARYS 2 FLEX PIERCING instruments are classified by FDA as Class II device. Sebia is seeking clearance to import the CAPILLARYS 2 and CAPILLARYS 2 FLEX PIERCING device described above, and by this submission is notifying FDA of its intent to market these products in the United States.
| 510K Table of Predicate Devices | |||
|---|---|---|---|
| Predicate Devices | 510K | Sample Type | Clearance date |
| HYDRAGEL IF kits | K960669 | Serum | July 12, 1996 |
| CAPILLARYS IMMUNOTYPING | K042939 | Serum | June 27, 2005 |
| CAPILLARYS IMMUNOTYPING | K082085 | Urine | April 17, 2009 |
| IT/IF Control | K101863 | Serum/ Urine | November 7, 2011 |
| Paragon CZE 2000 IFE/s Control | K002799 | Serum/Urine | October 5, 2000 |
Supporting labeling can be found in section IV that includes the package insert labeling of the prior cleared products and predicate devices.
PRODUCT DESCRIPTION
1. CAPILLARYS 2 instrument, Part Number 1222
2. CAPILLARYS 2 FLEX PIERCING instrument, Part Number 1227
3. Reagent Kits
The configurations of the CAPILLARYS IMMUNOTYPING kits consist of the components summarized in Tables I and II. Additional details are provided in Package Inserts included in Section III of the submission. Each kit with instrument is supplied with Package Insert/manual
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CAPILLARYS IMMUNOTYPING & CAPILLARYS 2 / CAPILLARYS 2 FLEX PIERCING instrument IT / IF CONTROL & CAPILLARYS 2
July 2013
which contains instruction for use and all the necessary information on the components needed to run the test that are sold separately. Each Package insert also contains information on storage conditions, shelf-life and signs of deterioration of the kit components and the reagents sold separately.
REAGENTS AND MATERIALS SUPPLIED IN THE CAPILLARYS TABLE --IMMUNOTYPING KIT (PN 2100) presented in prior 510K submissions
| ITEM | PN 2100 | 510K file withreagent supportingdata | Sample Type |
|---|---|---|---|
| CAPILLARYS IMMUNOTYPINGsegments | 60 ea. | K042939 | Serum |
| CAPILLARYS IMMUNOTYPINGsegments | 60 ea. | K082085 | Urine |
| ITEM | PN 4788 | 510K file withreagent supportingdata | Matrix of Control |
|---|---|---|---|
| IT/IF Control | 1 vial, 1mL ea. | K101863 | Serum based |
TABLE II. REAGENTS AND MATERIALS REQUIRED BUT NOT SUPPLIED IN THE CAPILLARYS IMMUNOTYPING KIT which were presented in prior 510K submissions
| ITEM | PN | Components | 510K file with reagentsupporting data |
|---|---|---|---|
| CAPILLARYSPROTEIN(E) 6 kit | 2003 | 2 vials, 700mL ea. | K042939, K082085 |
| Capiclean | 2051 | 1 vial, 12mL. | K042939, K082085 |
| CAPILLARYS washsolution | 2052 | 2 vials, 70mL ea. | K042939, K082085 |
LABELING
Labeling is described in Section III.
- A. CAPILLARYS 2 instrument operators manual
- B. CAPILLARYS IMMUNOTYPING package insert
- C. IT / IF CONTROL package insert
- D. CAPILLARYS 2 FLEX PIERCING instrument operators manual
- E. PHORESIS software
AND EQUIVALENCE (CONCORDANCE), SUBSTANTIAL COMPARISON PERFORMANCE STUDIES
4
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CAPILLARYS IMMUNOTYPING & CAPILLARYS 2 / CAPILLARYS 2 FLEX PIERCING instrument IT / IF CONTROL & CAPILLARYS 2
July 2013
A. The performance and comparative studies of the CAPILLARYS IMMUNOTYPING KIT used with the CAPILLARYS 2 instrument for serum and urine specimens were performed using Sebia's commercially available materials and standard procedures. Comparative studies were conducted with the predicate devices. Sebia HYDRAGEL IF kit. K960669.
The CAPILLARYS IMMUNOTYPING on the CAPILLARYS 2 Instrument for serum and urine specimens was found, experimentally and conceptually, substantially equivalent in assay principle, function, use, safety and effectiveness to predicates: Sebia HYDRAGEL IF kit using the Hydrasys instrument.
- B. The performance and comparative studies of the IT/IF Control using the CAPILLARYS IMMUNOTYPING kit with CAPILLARYS 2 instrument was compared to the predicate device, Paragon CZE 2000 IFE/s Control, K002799. The IT/IF control was found, experimentally and conceptually, substantially equivalent in assay, principal, function, use, safety and effectiveness to the predicate: Paragon CZE 2000 IFE/s Control.
- C. The performance and comparative studies of the CAPILLARYS IMMUNOTYPING KIT used with the CAPILLARYS 2 instrument compared to the CAPILLARYS 2 FLEX PIERCING instrumen for serum and urine specimens.
The CAPILLARYS IMMUNOTYPING on the CAPILLARYS 2 FLEX PIERCING Instrument was found substantially equivalent in assay, principle, function, use and safety and effectiveness to the CAPILLARYS 2 instrument for serum and urine samples.
STANDARDS
At the present time no performance standards exist for this type of In Vitro Diagnostic test (Section VII).
STATEMENT OF MANUFACTURE AND MANUFACTURING CONTROLS
The CAPILLARYS 2 and CAPILLARYS 2 FLEX PIERCING instrument, reagent 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.
Sebia has been certified against ISO 9001 / ISO 13485.
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CAPILLARYS IMMUNOTYPING & CAPILLARYS 2 / CAPILLARYS 2 FLEX PIERCING instrument IT / IF CONTROL & CAPILLARY'S 2
July 2013
・、
.
The CAPILLARYS IMMUNOTYPING KIT USING THE CAPILLARYS 2 and IT/IF control devices are for In Vitro Diagnostic Use. The Capillarys IMMUÑOTYPING KIT USING THE CAPILLARYS 2 FLEX PIERCING 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. 400-1705 Corporate drive, Norcross GA 30093 Phone 770 446-3707; Fax 770 446-8511
MARKETING INFORMATION
Sebia's CAPILLARYS IMMUNOTYPING KIT USING THE CAPILLARYS 2 AND IT/IF CONTROL and CAPILLARYS IMMUNOTYPING KIT USING THE CAPILLARYS 2 FLEX PIERCING will be offered for sale in the United States to the following market segments/users:
- Hospital clinical diagnostic laboratories 1.
- Private diagnostic laboratories 2.
- Reference diagnostic laboratories 3.
Sebia's products are currently being sold to the above type of diagnostic laboratories worldwide.
PREMARKET NOTIFICATIONS
Signed and dated "519(k) Statement" and "Truthful and Accurate Statement" are included in this 510(k) submission (Section X and XI)
INDICATION FOR USE FORM
The IFU form is included in this 510(k) submission for the CAPILLARYS IMMUNOTYPING KIT and the IT/IF CONTROL.
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Image /page/6/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The words are arranged on a single line and centered horizontally. The text is likely part of a document or presentation related to the Department of Health and Human Services.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 26, 2013
SEBIA INC. C/O MS. KAREN ANDERSON, MT (ASCP) DIRECTOR OF TECHNICAL TRAINING AND QUALITY ASSURANCE SUITE 400 1705 CORPORATE DRIVE NORCROSS GA 30093
Re: K130500
Trade/Device Name: CAPILLARYS IMMUNOTYPING (PN 2100) and IT/ IF CONTROL (PN4788) using the CAPILLARYS 2 Instrument (PN 1222) and CAPILLARYS 2 FLEX-PIERCING Instrument (PN 1227) Regulation Number: 21 CFR 866.5510 Regulation Name: Immunoglobulins A, G, M, D, and E immunological test system Regulatory Class: II Product Code: CFF, DFH, DEH, CEF, JJY Dated: July 22, 2013 , · Received: July 25, 2013
Dear Ms. Anderson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rollowe 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 rou may, merelors, mans of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 Parts 801 and 809); medical device reporting (reporting of
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Page 2-Ms. Karen Anderson
medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 regulations (21 CFR Parts 801 and 809), please contact 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/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Maria M. Chan -S
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: CAPILLARYS IMMUNOTYPING
Indications for Use:
The CAPILLARYS IMMUNOTYPING kit is designed for the detection and the characterization of monoclonal proteins (immunotyping) in human urine and serum with the CAPILLARYS, the CAPILLARYS 2 and the CAPILLARYS 2 FLEX-PIERCING, SEBIA, for capillary electrophoresis. It is used in conjunction with the SEBIA CAPILLARYS PROTEIN(E) 6 kit designed for proteins separation into 6 major fractions in alkaline buffer (pH 9.9).
The CAPILLARYS, CAPILLARYS 2 and the CAPILLARYS 2 FLEX-PIERCING perform all procedural sequences automatically to obtain a protein profile for qualitative analysis. Each urine or serum sample is mixed with individual antisera that are specific against gamma (Ig G), alpha (Ig A) and mu (Ig M) heavy chains, and kappa (free and bound) light chains and lambda (free and bound) light chains, respectively .
The proteins, separated in silica capillaries, are directly detected by their absorbance at 200 nm.
The electrophoregrams are evaluated visually to detect the presence of specific reactions with the suspect monoclonal proteins.
For In Vitro Diagnostic Use.
Prescription Use __ X (21 CFR Part 801 Subpart D) Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
And/Or
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Maria M. Chan -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
:
510(k)_k130500
{9}------------------------------------------------
Indications for Use
510(k) Number (if known): K130500
Device Name: IT / IF CONTROL
Indications for Use:
The IT / IF Control is designed to quality control the qualitative the detection and characterization of human monoclonal immunoglobulins (Ig G, Ig A, Ig M, Kappa and Lambda) with the electrophoresis methods:
- electrophoresis on SEBIA Immunotyping performed using capillary -CAPILLARYS 2 and CAPILLARYS 2 FLEX PIERCING instruments and on SEBIA MINICAP instrument.
- Immunofixation methods: SEBIA HYDRAGEL IF, HYDRAGEL IF Penta, . HYDRAGEL BENCE JONES (Standard mask and Dynamic mask) performed using the HYDRASYS and HYDRASYS 2 instruments and the K20 electrophoresis chamber.
The IT / IF Control is designed for laboratory use. It should be used (with its barcode label for CAPILLARYS and MINICAP procedures) like a human serum sample. The electrophoretic pattern obtained is specific for each batch of IT/IF control.
And/Or
For In Vitro Diagnostic Use.
Prescription Use X ____________________________________________________________________________________________________________________________________________________________________________ (21 CFR Part 801 Subpart D)
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) Maria M. Chan -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) K130500
§ 862.1630 Protein (fractionation) test system.
(a)
Identification. A protein (fractionation) test system is a device intended to measure protein fractions in blood, urine, cerebrospinal fluid, and other body fluids. Protein fractionations are used as an aid in recognizing abnormal proteins in body fluids and genetic variants of proteins produced in diseases with tissue destruction.(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.