(29 days)
The REAADS® II Anti-Cardiolipin IgM Semi-Quantitative Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative determination of anti-cardiolipin IgM antibodies in human serum or plasma. For the detection and semi-quantitation of anti-cardiolipin antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). The REAADS® II Anti-Cardiolipin IgM Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.
The REAADS® II Anti-Cardiolipin IgG Semi-Quantitative Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative determination of anti-cardiolipin IgG antibodies in human serum or plasma. For the detection and semi-quantitation of anti-cardiolipin antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). The REAADS® II Anti-Cardiolipin IgG Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.
The REAADS® II Anti-Cardiolipin IgA Semi-Quantitative Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative determination of anti-cardiolipin IgA antibodies in human serum or plasma. For the detection and semi-quantitation of anti-cardiolipin antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). The REAADS® II Anti-Cardiolipin IgA Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.
The REAADS II Anti-Phosphatidylserine IgG Semi-Quantitative Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative determination of anti-phosphatidylserine IgG antibodies in human serum or citrated plasma (3.2% sodium citrate). Detection and semi-quantitation of anti-phosphatidylserine antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). The REAADS® II Anti-Phosphatidylserine IgG Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.
The REAADS II Anti-Phosphatidylserine IgM Semi-Quantitative Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative determination of anti-phosphatidy/serine IgM antibodies in human serum or citrated plasma (3.2% sodium citrate). Detection and semi-quantitation of anti-phosphatidylserine antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). The REAADS® II Anti-Phosphatidylserine IgM Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.
The REAADS® II Anti-Phosphatidylserine IgA Semi-Quantitative Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative determination of anti-phosphatidylserine (aPS) IgA antibodies in human serum and citrated plasma (3.2% sodium citrate). Detection and semi-quantitation of anti-phosphatidylserine antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). The REAADS® II Anti-Phosphatidylserine IgA Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.
The REAADS® II Anti-Beta 2 Glycoprotein I IgG Semi-Quantitative Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative determination of anti-Beta 2 Glycoprotein 1 (B2GP1) IgG antibodies in human serum or citrated plasma (3.2% sodium citrate). For the detection and semi-quantitation of anti-ß2GPI IgG antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). The REAADS® II Anti-Beta 2 Glycoprotein I IgG Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.
The REAADS® II Anti-Beta 2 Glycoprotein I IgM Semi-Quantitative Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative determination of anti-Beta 2 Glycoprotein l (ß2GPI) IgM antibodies in human serum or citrated plasma (3.2% sodium citrate). For the detection and semi-quantitation of antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). The REAADS® II Anti-Beta 2 Glycoprotein I IgM Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.
The REAADS® II Anti-Beta 2 Glycoprotein 1 IgA Semi-Quantitative Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative determination of anti-Beta 2 Glycoprotein 1 (B2GPI) IgA antibodies in human serum or citrated plasma (3.2% sodium citrate). For the detection and semi-quantitation of antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). The REAADS® II Anti-Beta 2 Glycoprotein 1 IgA Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.
The REAADS® II Anti-Prothrombin IgG Semi-Quantitative Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative determination of anti-prothrombin (aPT) IgG antibodies in human serum or citrated plasma (3.2% sodium citrate). For the detection and semi-quantitation of anti-prothrombin (aPT) IgG antibodies with systemic lupus erythematosus (SLE) and lupus-like disorders (e.g., antiphospholipid syndrome). The REAADS® II Anti- Prothrombin IgG Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.
The REAADS® II Anti-Prothrombin IgM Semi-Quantitative Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative determination of anti-prothrombin (aPT) IgM antibodies in human serum or citrated plasma (3.2% sodium citrate). For the detection and semi-quantitation of anti-prothrombin (aPT) IgM antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (e.g., antiphospholipid syndrome). The REAADS® II Anti- Prothrombin IgM Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.
The device is an enzyme-linked immunosorbent assay (ELISA) kit for the semi-quantitative determination of specific antibodies in human serum or plasma.
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, sample sizes for test or training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, or how ground truth was established for "REAADS II anti-Cardiolipin IgG Semi-quantitative Test Kit" or any of the other listed REAADS II test kits.
The document is a 510(k) premarket notification letter from the FDA to Corgenix, Inc., confirming substantial equivalence for a series of REAADS II anti-phospholipid antibody test kits. It primarily lists the device names, regulation numbers, regulatory class, product codes, and indications for use for each kit. While it states that the FDA "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent...", it does not provide the details of the studies or data that led to this determination.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three heads facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Corgenix, Inc. c/o Ms. Nanci Dexter Director of Quality and Regulatory Affairs 12061 Tejon Street Westminster, Colorado 80234
OCT 2 0 2003
Re: K032868
Device Name: REAADS II anti-Cardiolipin IgG Semi-quantitative Test Kit REAADS II anti-Cardiolipin IgM Semi-quantitative Test Kit REAADS II anti-Cardiolipin IgA Semi-quantitative Test Kit REAADS II anti-Phosphatidylserine IgG Semiquantitative Test Kit REAADS II anti-Phosphatidylserine IgM Semiquantitative Test Kit REAADS II anti-Phosphatidylserine IgA Semiquantitative Test Kit REAADS II anti-Beta 2 Glycoprotein I IgG Semi-Quantitative Test Kit REAADS II anti-Beta 2 Glycoprotein I IgM Semi-Quantitative Test Kit REAADS II anti-Beta 2 Glycoprotein I IgA Semi-Quantitative Test Kit REAADS II anti-Prothrombin IgG Semi-Quantitative Test Kit REAADS II anti-Prothrombin IgM Semi-Quantitative Test Kit
Regulation Number: 21 CFR § 866.5660 Regulation Name: Multiple Autoantibodies Immunological Test System Regulatory Class: II Product Code: MID, MSV, DHC Dated: September 12, 2003 Received: September 15, 2003
Dear Ms. Dexter:
This letter corrects our substantially equivalent letter of October 14, 2003 regarding the incorrect company name. We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Nanci Dexter
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); and 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 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
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510(k) Number: K032868
Device Name: REAADS® II Anti-Cardiolipin IgM Semi-Quantitative Test Kit
Indications for Use:
The REAADS® II Anti-Cardiolipin IgM Semi-Quantitative Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative determination of anti-cardiolipin IgM antibodies in human serum or plasma.
For the detection and semi-quantitation of anti-cardiolipin antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome).
The REAADS® II Anti-Cardiolipin IgM Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
J. P. Rews for T. J. O'Leary
Division Sign-Off
510(k) K032868
Prescription Use $\underline{V}$
{3}------------------------------------------------
510(k) Number: K032868
Device Name: REAADS® II Anti-Cardiolipin IgG Semi-Quantitative Test Kit
Indications for Use:
The REAADS® II Anti-Cardiolipin IgG Semi-Quantitative Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative determination of anti-cardiolipin IgG antibodies in human serum or plasma.
For the detection and semi-quantitation of anti-cardiolipin antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome).
The REAADS® II Anti-Cardiolipin IgG Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
J.P. Reeves for T.J. Wilson/
Division Sign-Off
510(k) K032868
Prescription Use $\checkmark$
{4}------------------------------------------------
510(k) Number: K032868
Device Name: REAADS® II Anti-Cardiolipin IgA Semi-Quantitative Test Kit
Indications for Use:
The REAADS® II Anti-Cardiolipin IgA Semi-Quantitative Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative determination of anti-cardiolipin IgA antibodies in human serum or plasma.
For the detection and semi-quantitation of anti-cardiolipin antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome).
The REAADS® II Anti-Cardiolipin IgA Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
E.J.P.Leves for P.J.O'Leary
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)_KO32868
Prescription Use ✓
{5}------------------------------------------------
510(k) Number: K032868
Device Name: REAADS® II Anti-Phosphatidylserine IgG Semi-Quantitative Test Kit
Indications for Use:
The REAADS II Anti-Phosphatidylserine IgG Semi-Quantitative Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative determination of anti-phosphatidylserine IgG antibodies in human serum or citrated plasma (3.2% sodium citrate).
Detection and semi-quantitation of anti-phosphatidylserine antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome).
The REAADS® II Anti-Phosphatidylserine IgG Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
A.P. Reeves for D.L. U'Hearn
Division Sign-Off.
510(k) K032868
Prescription Use $\checkmark$
{6}------------------------------------------------
510(k) Number: K032868
Device Name: REAADS® II Anti-Phosphatidylserine IgM Semi-Quantitative Test Kit
Indications for Use:
The REAADS II Anti-Phosphatidylserine IgM Semi-Quantitative Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative determination of anti-phosphatidy/serine IgM antibodies in human serum or citrated plasma (3.2% sodium citrate).
Detection and semi-quantitation of anti-phosphatidylserine antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome).
The REAADS® II Anti-Phosphatidylserine IgM Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
AFReeve for T.J. O'leary
Division Sign-Off
Division Sign-Off
510(k) K032868
Prescription. Use $\underline{ \checkmark }$
{7}------------------------------------------------
510(k) Number: K032868
Device Name: REAADS® II Anti-Phosphatidylserine IgA Semi-Quantitative Test Kit
Indications for Use:
The REAADS® II Anti-Phosphatidylserine IgA Semi-Quantitative Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative determination of anti-phosphatidylserine (aPS) IgA antibodies in human serum and citrated plasma (3.2% sodium citrate).
Detection and semi-quantitation of anti-phosphatidylserine antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome).
The REAADS® II Anti-Phosphatidylserine IgA Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
J.P. Reeves for T.J. O'Leary
Division Sign-Off
510(k) K032868
Prescription Use $\underline{ \checkmark }$
{8}------------------------------------------------
510(k) Number: K032868
Device Name: REAADS® II Anti-Beta 2 Glycoprotein I IgG Semi-Quantitative Test Kit
Indications for Use:
The REAADS® II Anti-Beta 2 Glycoprotein I IgG Semi-Quantitative Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative determination of anti-Beta 2 Glycoprotein 1 (B2GP1) IgG antibodies in human serum or citrated plasma (3.2% sodium citrate).
For the detection and semi-quantitation of anti-ß2GPI IgG antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome).
The REAADS® II Anti-Beta 2 Glycoprotein I IgG Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
A.P. Reeves for T.J. O'leary
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) KO32868
Prescription Use √
{9}------------------------------------------------
510(k) Number: K032868
Device Name: REAADS® II Anti-Beta 2 Glycoprotein I IgM Semi-Quantitative Test Kit
Indications for Use:
The REAADS® II Anti-Beta 2 Glycoprotein I IgM Semi-Quantitative Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative determination of anti-Beta 2 Glycoprotein l (ß2GPI) IgM antibodies in human serum or citrated plasma (3.2% sodium citrate).
For the detection and semi-quantitation of antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome).
The REAADS® II Anti-Beta 2 Glycoprotein I IgM Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
A. Reus for T.J. O'leary
Division Sign-Off
510(k) K032868
Prescription Use ✓
{10}------------------------------------------------
510(k) Number: K032868
Device Name: REAADS® II Anti-Beta 2 Glycoprotein 1 IgA Semi-Quantitative Test Kit
Indications for Use:
The REAADS® II Anti-Beta 2 Glycoprotein I IgA Semi-Quantitative Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative determination of anti-Beta 2 Glycoprotein 1 (B2GPI) IgA antibodies in human serum or citrated plasma (3.2% sodium citrate).
For the detection and semi-quantitation of antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome).
The REAADS® II Anti-Beta 2 Glycoprotein I IgA Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
A.L. Reeves for T.J. O'leary
Division Sign-Off
510(k) K032868
Prescription Use /
{11}------------------------------------------------
510(k) Number: K032868
Device Name: REAADS® II Anti-Prothrombin IgG Semi-Quantitative Test Kit
Indications for Use:
The REAADS® II Anti-Prothrombin IgG Semi-Quantitative Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative determination of anti-prothrombin (aPT) IgG antibodies in human serum or citrated plasma (3.2% sodium citrate).
For the detection and semi-quantitation of anti-prothrombin (aPT) IgG antibodies with systemic lupus erythematosus (SLE) and lupus-like disorders (e.g., antiphospholipid syndrome).
The REAADS® II Anti- Prothrombin IgG Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
J.P. Reeves for T.J. d'Leary
Division Sign-Off
510(k) K032868
Prescription Use ✓
{12}------------------------------------------------
510(k) Number: K032868
Device Name: REAADS® II Anti-Prothrombin IgM Semi-Quantitative Test Kit
Indications for Use:
The REAADS® II Anti-Prothrombin IgM Semi-Quantitative Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative determination of anti-prothrombin (aPT) IgM antibodies in human serum or citrated plasma (3.2% sodium citrate).
For the detection and semi-quantitation of anti-prothrombin (aPT) IgM antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (e.g., antiphospholipid syndrome).
The REAADS® II Anti- Prothrombin IgM Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
J.P. Reeves for A.J. O'Leary
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K032868
Preseription Use I
§ 866.5660 Multiple autoantibodies immunological test system.
(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).