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510(k) Data Aggregation
(122 days)
The Clungene RSV Antigen Rapid Test is a lateral flow immunoassay intended for the qualitative detection of respiratory syncytial virus (RSV) nucleoprotein antigen in nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection. The test is intended for in vitro diagnostic use as an aid in the diagnosis of RSV infections.
Negative results do not preclude RSV infection and should not be used as the sole basis for treatment or patient management decisions. A negative test is presumptive. It is recommended that negative test results be confirmed by viral cell culture or an FDA-cleared molecular assay.
The Clungene RSV Antigen Rapid Test is a lateral flow immunoassay based on the principle of the double-antibody sandwich technique. The nasopharyngeal swab from individuals is processed by the extraction buffer in buffer tube. After the extracted sample is added into the specimen well, the respiratory syncytial virus (RSV) nucleoprotein antigen in the sample will react with anti-RSV antigen antibody conjugated with color micro particles to form an antigen-antibody labeled complex. This complex migrates on the membrane via capillary action until the test line, where it will be captured by the pre-coated anti-RSV antigen antibody. If the specimen contains RSV nucleoprotein antigen, a colored line will appear in the test line (T) region indicating a positive result. If the specimen does not contain RSV nucleoprotein antigen, a colored line will not appear in this region indicating a negative result. To serve as a procedural control, a colored line will always appear at the control line (C) region indicating that proper volume of specimen has been added and membrane wicking has occurred.
The test result should be read at 15-20 minutes after adding the extracted sample is added into the specimen well. One line in the control line region (C), and another line in the test line region (T) indicates a positive result, regardless of color intensity. When only One line is present in the control region(C) and no line is present in the test line region (T) results are negative result. If the control line(C) fails to appear, the result is invalid, and the operator should review the procedure and repeat the test with a new test cassette.
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(280 days)
The EZ-Protect™ Hydrophilic Closed System Intermittent Catheter is intended to drain urine from the bladder.
The EZ-Protect Hydrophilic Closed System Intermittent Catheters and EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits are sterile, closed system, single use, disposable, hydrophilic coated PVC catheter with either a straight or coude tip, self-contained along with a water sachet pouch to activate the hydrophilic coating and a collection bag. The EZ-Protect Hydrophilic Closed System Intermittent Catheters and EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits are used to drain urine from the bladder. The EZ-Protect Hydrophilic Closed System Intermittent Catheters are 16 inches in length and in sizes from 8 Fr. to 18 Fr. The EZ-Protect Hydrophilic Closed System Intermittent Catheters are designed with the collection bag and introducer tip allowing the user to insert the catheter without having to touch the catheter.
The EZ-Protect Hydrophilic Closed System Intermittent Catheter Kit consists of components used to drain urine from the bladder. The EZ-Protect Hydrophilic Closed System Intermittent Catheter Kit contains the sterile EZ-Protect Hydrophilic Closed System Intermittent Catheter (subject of this submission) along with the following Class I, exempt devices: gauze pad, Benzalkonium Chloride (BZK) swab/wipe, gloves, underpad and privacy disposal. The kit components are purchased, off the shelf by the kit packager Hangzhou Jimushi Medical CO., LTD. (Uricare). These components are similar to those provided in predicate device Rusch Hydrophilic Intermittent catheters (K183461) and reference device MTG Instant Cath (K080878).
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(266 days)
The EK Dental Abutments are indicated for use with EK Dental Implants to provide support to prosthetic restoration such as crowns, bridges and overdentures in partially or fully edentulous patients.
The EK Multi Angled 30 Dental Abutments are indicated for use with EK Dental Implants to provide support to prosthetic restoration such as crowns, bridges and overdentures in partially or fully edentulous patients. Manufactured from medical grade titanium alloy and delivered non-sterilized. The EK Multi Angled 30 Abutments are available in various lengths and diameters.
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(220 days)
It is intended for use under endoscopic visualization for the morcellation and removal of dissected benign prostatic hyperplasia (BPH) tissue during endoscopic surgical procedures in urology.
The device includes a control unit, handpiece, footswitch, blades, waste bottle, collection bottle, and suction tube. The device is a reusable morcellation device which is intended for use under endoscopic visualization for the morcellation and removal of dissected benign prostatic hyperplasia (BPH) tissue during endoscopic surgical procedures.
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(1 days)
LumiCera is used for fabricating permanent single crowns, permanent inlays and onlays, veneers, bridges.
The product should be used in combination with SHINING3D printer. The product is a liquid photo-curable material, which is produced by free radical polymerization of oligomers triggered by photoinitiator contained in the resin. The resin is printed in multiple layers automatically, with each layer being subjected to light curing before the addition of the next layer, and then undergoes post-curing in a curing device. The product is intended exclusively for professional dental work.
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(136 days)
The NOVEOS Specific IgE assay is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum. NOVEOS Specific IgE assay is to be used with the NOVEOS Immunoassay Analyzer. It is intended for use as an in vitro diagnostic aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings and is to be used in clinical laboratories.
The NOVEOS Specific IgE assay is an immunometric, chemiluminescent procedure for the quantitative determination of IgE of known specificity in human serum samples. It employs fluorescent labelled magnetic, streptavidin coated microparticles which are incubated with a biotinylated allergenic capture reagent, patient sample and monoclonal anti-human IgE antibody: horseradish peroxidase conjugate. If present in the sample, IgE binds to the biotinylated allergen captured to the streptavidin-coated microparticles to form a complex. After a final wash, the resulting complex is incubated with the enzyme substrate and a chemiluminescent signal is generated, the magnitude of which is proportional to the concentration of IgE in the patient sample.
The concentration of allergen-specific IgE is determined from a standard curve, which is traceable to the World Health Organization (WHO) reference reagent serum Immunoglobulin E (IgE) 11/234.
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(118 days)
Pen Needles are sterile, single use needles intended for using with pen injector devices for the injection of drug.
The Pen Needle is a sterile, single use device intended for use with pen injector devices for the subcutaneous injection of drug. The device is available in ordinary and safety configurations.
The following are the types of needles:
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Ordinary Type I, Ordinary Type IB, Ordinary Type VIA, Ordinary Type VIB, and Ordinary Type VIC needle consists of needle hub, double-ended needle tube, which is bonded with the needle hub with joining medium, needle container, needle shield, and seal paper.
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Safety Type IIA, Safety Type IIB, and Safety Type IIIA needle consists of needle hub, double-ended needle tube, which is bonded with the needle hub with joining medium, needle container, needle shield, needle cover, spring, and seal paper.
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Safety Type IIIB, Safety Type VII, Safety Type VIII, and Safety Type IX needle consists of needle hub, double-ended needle tube, which is bonded with the needle hub with joining medium, needle container, needle shield, needle cover, inner core, spring, and seal paper.
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Safety Type IV needle consists of needle hub, double-ended needle tube, which is bonded with the needle hub with joining medium, needle container, needle shield, needle cover, inner core, rear inner core, spring, and seal paper.
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Safety Type V and Safety Type X needle consists of needle hub, double-ended needle tube, which is bonded with the needle hub with joining medium, needle container, needle shield, needle cover, inner core, rear needle shield, spring, rear spring and seal paper.
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Ordinary Type XI needle consists of needle hub, double-ended needle tube, which is bonded with the needle hub with joining medium, needle container, needle shield, adjusting sleeve and seal paper.
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Safety Type XII needle consists of needle hub, double-ended needle tube, which is bonded with the needle hub with joining medium, needle container, needle shield, needle cover, inner core, rear needle shield, adjusting sleeve, spring, rear spring and seal paper.
The needle shield and rear needle shield provide physical protection to the needle tube before and after use. The needle container together with seal paper forms the primary sterile barrier system and protects the needle hub. The hub is designed to be securely screwed onto the needle-based injection system (e.g. pen injector) for the subcutaneous injection of drug.
The product is individually packaged and sterilized by irradiation to achieve a sterility assurance level (SAL) of 10⁻⁶. It is intended for single use only.
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(86 days)
Feather/numiere 05 06 07 (05) is an Over the-Counter (OTC) device intended for the use in treating wrinkles on the decolletage.
Feather/ numiere 05 06 07 (Models: 05) is an over-the-counter light-emitting diode (LED) device that emits energy for the treatment of wrinkles. The device works by simultaneously emitting 630nm±10nm, 830nm ±10nm wavelengths for the treatment of wrinkles on the neck and decolletage (upper chest). The device is designed in a flexible silicone panel that contains red (630nm±10nm) and near infrared (830nm±10nm) light-emitting diodes (LEDs). The device also contains a controller that controls the power on and off of the device, and regulates the intensity of the treatment by pressing buttons, and the controller
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(327 days)
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(194 days)
The Healgen® URS Test Strips are for the qualitative detection of leukocytes (white blood cells) and nitrite in urine as an aid in the screening of a urinary tract infection (UTI). It is intended for over-the-counter home use only.
The Healgen® URS Test Strips are in vitro diagnostic test devices for the qualitative detection of leukocytes and nitrites in urine. The device is composed of two color pads aligned on a strip. One pad is employed for testing leukocytes and the other for nitrites by visually reading the color change of the applicable pad and comparing with the corresponding blocks on a color chart.
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