(90 days)
The CAPILLARYS URINE kit is designed for the preparation of urine samples before separation of human urine proteins in alkaline buffer (pH 9.9) with the CAPILLARYS system. The CAPILLARYS performs automatically all sequences to obtain a urinary protein profile for qualitative analysis. The proteins, separated in silica capillaries, are directly detected at an absorbance of 200 nm. The electrophoretograms can be interpreted visually to detect for any pattern abnormalities (monoclonal components, particularly Bence Jones proteins and other urinary proteins). The test results should be used in conjunction with clinical and laboratory findings.
Not Found
I am sorry, but the provided text does not contain the detailed information necessary to answer your request about the acceptance criteria and the study that proves the device meets them.
The document is an FDA 510(k) clearance letter for the CAPILLARYS URINE device. It confirms that the device is substantially equivalent to a legally marketed predicate device but does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, or details about the test set.
- Information on experts, adjudication methods, or ground truth establishment for a test set.
- Details about multi-reader multi-case studies or standalone algorithm performance.
- Training set sample size or how its ground truth was established.
This document is a regulatory approval, not a scientific study report.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around a symbol. The symbol consists of four stylized human figures, representing the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Sebia, Inc. c/o Ms. Karen Anderson Director of Technical Training and Regulatory 1705 Corporate Drive Suite 400 Norcross, GA 30093
Re: K080916 Trade/Device Name: CAPILLARYS URINE, PN 2012 Regulation Number: 21 CFR 866.5150 Regulation Name: Bence Jones proteins immunological systems Regulatory Class: Class II Product Code: JKM Dated: June 16, 2008 Received: June 19, 2008
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.
JIJ -1 2008
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The
{1}------------------------------------------------
Page 2 -
FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. 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 Survcillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
In Chan
Maria M. Chan, Ph.D. Acting Division Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Page 1 of 1
CAPILLARYS URINE
510(K) Number: K080916
(Special 510(K): Device modification)
Device name:
CAPILLARYS URINE, PN 2012
Indications For Use:
The CAPILLARYS URINE kit is designed for the preparation of urine samples before separation of human urine proteins in alkaline buffer (pH 9.9) with the CAPILLARYS system. The CAPILLARYS performs automatically all sequences to obtain a urinary protein profile for qualitative analysis. The proteins, separated in silica capillaries, are directly detected at an absorbance of 200 nm. The electrophoretograms can be interpreted visually to detect for any pattern abnormalities (monoclonal components, particularly Bence Jones proteins and other urinary proteins). The test results should be used in conjunction with clinical and laboratory findings.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
✓
OR
Over-The Counter Use
(Optional Format 1-2-96)
Mare M Clan
Division Sign-Off
Office of in Viter Tican
K080911e
§ 866.5150 Bence-Jones proteins immunological test system.
(a)
Identification. A Bence-Jones proteins immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the Bence-Jones proteins in urine and plasma. Immunoglobulin molecules normally consist of pairs of polypeptide chains (subunits) of unequal size (light chains and heavy chains) bound together by several disulfide bridges. In some cancerous conditions, there is a proliferation of one plasma cell (antibody-producing cell) with excess production of light chains of one specific kind (monoclonal light chains). These free homogeneous light chains not associated with an immunoglobulin molecule can be found in urine and plasma, and have been called Bence-Jones proteins. Measurement of Bence-Jones proteins and determination that they are monoclonal aid in the diagnosis of multiple myeloma (malignant proliferation of plasma cells), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins by spleen and bone marrow cells), leukemia (cancer of the blood-forming organs), and lymphoma (cancer of the lymphoid tissue).(b)
Classification. Class II (performance standards).