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The OSOM C. difficile Toxin A/B Test is an immunochromatographic assay intended for the qualitative detection of Clostridium difficile toxins A and/or B in human stool samples. This test is intended as an aid in the diagnosis of C. difficile-associated disease (CDAD) in patients with symptoms of CDAD.

The OSOM C. difficile Toxin A/B Test is a rapid test which can detect the presence of Clostridium difficile toxins A and B in human stool samples. A test kit contains 25 OSOM test stick devices and 25 disposable pipettes. The OSOM C. difficile Toxin A/B Test is a qualitative assay that employs immunochromatographic, dipstick technology. The test format is a sandwich immunoassay, with a single test zone on the nitrocellulose dipstick to detect Toxin A and/or Toxin B ("blue/gray" line) and a single control line zone to indicate proper sample flow ("red" line). The test procedure involves binding of C. difficile Toxin A and/or Toxin B from a patient stool sample to blue colored latex particles conjugated to a monoclonal antibody against Toxin B or a polyclonal antibody against Toxin A. When Toxin A and/or B is present in the sample, it will form a partial immune complex with the antibody-conjugated colored particles. The OSOM C. difficile Toxin A/B Test stick, when placed in the sample mixture, initiates sample migration along the nitrocellulose membrane. If C. difficile toxin A or toxin B is present, a blue/gray line will appear in the test line region indicating a positive result. A red control line must appear for the results to be valid. If C. difficile toxins are not present, only the red control line will appear. An invalid test occurs when no control line appears.

The OSOM® Influenza A&B Test is an in vitro diagnostic immunochromatographic assay intended for the qualitative detection of influenza A and influenza B viral nucleoprotein antigens from nasal swab specimens in symptomatic patients. It is intended to aid in the rapid differential diagnosis of influenza A and/or B viral infections. This test is not intended for the detection of influenza C viruses. A negative test is presumptive and it is recommended these results be confirmed by cell culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions.

The OSOM Influenza A&B Test consists of a test stick that separately detects influenza A and B. The test procedure requires the solubilization of the nucleoproteins from a swab by mixing the swab in Extraction Buffer. The test stick is then placed in the sample mixture, which then migrates along the membrane surface. If influenza A and/or B viral antigens are present in the sample, it will form a complex with mouse monoclonal IgG antibodies to influenza A and/or B nucleoproteins conjugated to colloidal gold. The complex will then be bound by another mouse anti-influenza A and/or B antibody coated on the nitrocellulose membrane. A pink to purple control line must appear in the control region of the stick for results to be valid. The appearance of a second and possibly a third light pink to purple line will appear in the test line region indicating an A, B or A and B positive result.

Reagents: For the quantitative measurement of cystatin C concentration in human serum, heparinized plasma and EDTA plasma. Cystatin C measurements are used as an aid to the diagnosis and treatment of renal diseases. For In Vitro Diagnostic Use. Calibrator: For the calibration of Genzyme Cystatin C assay. For In Vitro Diagnostic Use.

Genzymc Cystatin C assay reagent is based on the sol particle turbidimetric immunoassay principle. It contains colloidal gold particles coated with anticystatin C specific polyclonal antibodies. The reaction between the particles and any cystatin C in samples results in the formation of agglutinates and an associated change in absorbance signal. The change in absorbance signal is proportional to the amount of cystatin C in the sample. Cystatin C concentration in the sample is determined by comparison with a standard curve. Genzyme Cystatin C calibrators consist of a bovine serum albumin liquid matrix with assigned concentrations of cystatin C. The calibrators are preserved with sodium azide and are ready to use.

Sepramesh™ IP Bioresorbable Coating/Permanent Mesh is indicated for use in the reconstruction of soft tissue deficiencies such as for the repair of hernias.

Sepramesh™ IP Bioresorbable Coating/Permanent Mesh (Sepramesh™ IP) is a dualcomponent (absorbable and non-absorbable), sterile prosthesis designed for the reconstruction of soft tissue deficiencies. Sepramesh™ IP is co-knitted using polypropylene and polyglycolic acid (PGA) fibers to result in a two-sided mesh with a polypropylene surface and PGA surface. Genzyme will offer two versions of the device. The first version utilizes violet dyed PGA fibers. The second version utilizes natural beige PGA fibers instead of the original violet version. The mesh is coated on the PGA surface with a bioresorbable coating of chemically modified sodium hyaluronate (HA), carboxymethylcellulose (CMC) and a polyethylene glycol (PEG) based hydrogel. The uncoated side of the mesh allows a prompt fibroblastic response through the interstices of the mesh, encouraging tissue ingrowth, similar to polypropylene mesh alone. The coated side of the mesh provides a hydrophilic bioresorbable layer, separating the mesh from underlying tissue and organ surfaces during the critical wound-healing period resulting in minimal tissue attachment and visceral adhesions to the mesh. Shortly after placement, the biopolymer coating becomes a hydrated gel that is resorbed from the site in less than 30 days. The absorption of the PGA fibers is essentially complete between 50 and 80 days. The polypropylene mesh is permanent and allows for tissue ingrowth.

Sepramesh™ IP Bioresorbable Barrier - Permanent Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.

Sepramesh™ IP Bioresorbable Coating/Permanent Mesh (Sepramesh™ IP) is a dualcomponent (absorbable and non-absorbable), sterile prosthesis designed for the reconstruction of soft tissue deficiencies. Sepramesh™ IP is co-knitted using polypropylene and polyglycolic acid (PGA) fibers to result in a two-sided mesh with a polypropylene surface and PGA surface. Genzyme will offer two versions of the device. The first version, previously cleared through K040868 utilizes violet dyed PGA fibers. The second version described in this submission utilizes natural beige PGA fibers. The mesh is coated on the PGA surface with a bioresorbable barrier of chemically modified sodium hyaluronate (HA), carboxymethylcellulose (CMC) and a polyethylene glycol (PEG) based hydrogel. The uncoated side of the mesh allows a prompt fibroblastic response through the interstices of the mesh, encouraging tissue ingrowth, similar to polypropylene mesh alone. The coated side of the mesh provides a hydrophilic bioresorbable layer, separating the mesh from underlying tissue and organ surfaces during the critical wound-healing period resulting in minimal tissue attachment and visceral adhesions to the mesh. Shortly after placement, the biopolymer coating becomes a hydrated gel that is resorbed from the site in less than 30 days. The absorption of the PGA fibers is essentially complete between 50 and 80 days. The polypropylene mesh is permanent and allows for tissue ingrowth.

Sepragel ENT packing/stent is indicated for use in patients undergoing nasal/sinus, middle ear and external ear canal surgery as a space-occupying dressing and/or stent intended to prevent adhesions in the nasal cavity, separate mucosal surfaces, help control minimal bleeding following surgery or trauma, and act as an adjunct to aid in the natural healing process. The device is indicated for use in the middle ear following canalplasty, myringoplasty, tympanoplasty, stapes and mastoid surgery. The device is indicated following nasal/sinus surgery or trauma to prevent lateralization of the middle turbinate during the post operative period.

Sepragel ENT is a sterile, non-pyrogenic, transparent, viscoelastic, bioresorbable gel composed of cross-linked molecules of hyaluronan. It is indicated for use in patients undergoing nasal/sinus, middle ear and external ear canal surgery as a space-occupying dressing and/or gel stent intended to separate and prevent adhesions between mucosal surfaces, to help control minimal bleeding following surgery or trauma, and act as an adjunct to aid in the natural healing process. SeprageI™ ENT hylan B gel, is a sterile, non-pyrogenic, transparent, viscoelastic gel composed of cross-linked molecules of hyaluronan. This hyaluronan is a bioresorbable material that functions to fill the sinus cavity, middle ear and external ear canal following surgery and to keep mucosal surfaces separate during the healing process. During this time, the tamponade effect helps control minimal bleeding normally associated with routine Otologic surgery. Sepragel ENT leaves the site of placement by natural elimination. In nasal/sinus applications it may be aspirated from the cavity earlier at the discretion of the physician.