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510(k) Data Aggregation
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Multichem ID-G: Multichem ID-G is intended for use as a qualitative positive quality control serum to monitor the precision of laboratory testing procedures for Anti-HBc IgG, Anti-HCV IgG, HBsAg, Anti-Treponema pallidum IgG and Anti-HIV 1 IgG detected by Roche cobas heterogeneous immunoassay systems. These products are not intended to replace manufacturer's recommended controls provided in their package insert. Quality Control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.
Multichem ID-GNeg: Multichem ID-GNeg is intended for use as a qualitative negative quality control serum to monitor the precision of laboratory testing procedures for Anti-HBc IgG, Anti-HCV IgG, HBsAg, Anti-Treponema pallidum IgG and Anti-HIV 1 IgG detected by the Roche cobas heterogeneous immunoassay systems. These products are not intended to replace manufacturer's recommended controls provided in their package insert. Quality Control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.
Multichem ID-G and Multichem ID-GNeg are each supplied as single level controls. These products are prepared from human plasma. Multichem ID-G contains Hepatitis B Surface Antigen (HBsAg), and lgG antibodies to HIV-1 (Human Immunodeficiency Virus Type 1), HCV (Hepatitis C Virus), HBc (Hepatitis B Core Antigen) and Treponema pallidum. Multichem ID-GNeg does not contain analytes for HBsAg, anti-HIV-1 lgG, anti-HCV lgG, anti-HBc lgG, and anti-Treponema pallidum lgG. These controls are provided in liquid form for convenience. Each control is available as either 1 or 4 vials x 4 ml/vial.
Multichem ID-G is manufactured by adding the required analytes to the negative delipidated human serum base matrix, described above. Human disease state plasma that has tested positive for the required analyte using an FDA-cleared/approved assay is used to spike the base matrix to each target specification and within the ranges set for the Roche Immunoassay systems (Tables 1 and 2).
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(179 days)
The LIAISON NES FLU A/B, RSV & COVID-19 assay is a real-time RT-PCR assay intended for use on the LIAISON NES instrument for the simultaneous in vitro qualitative detection and differentiation of nucleic acid from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A (Flu A) virus, influenza B (Flu B) virus, and respiratory syncytial virus (RSV) in anterior nasal swab specimens from individuals with signs and symptoms of respiratory tract infection. Clinical signs and symptoms of respiratory tract infection due to SARS-CoV-2, influenza A, influenza B, and RSV can be similar.
The LIAISON NES FLU A/B, RSV & COVID-19 assay is intended for use as an aid in the differential diagnosis of SARS-CoV-2, influenza A, influenza B, and RSV infections when used in conjunction with other clinical and epidemiological information, and laboratory findings. SARS-CoV-2, influenza A, influenza B, and RSV viral RNA are generally detectable in anterior nasal swab specimens during the acute phase of infection. This test is not intended to detect influenza C virus infections.
Positive results are indicative of the presence of the identified virus, but do not rule out bacterial infection or co-infection with other pathogens not detected by the test. The agent(s) detected by the LIAISON NES FLU A/B, RSV & COVID-19 assay may not be the definite cause of the disease. Negative results do not preclude SARS-CoV-2, influenza A, influenza B or RSV infection and should not be used as the sole basis for patient management decisions.
The LIAISON NES Instrument (NES1001) is capable of analysis of a single cartridge containing a single specimen. A set of parameters specific to the assay is included in the instrument software to name target molecules, assign dyes to probes, specify cycling conditions, and to analyze data from runs. Fluorescence intensity is monitored at each PCR cycle by detection modules within the instrument. The instrument software controls the thermocycling and, upon completion of the run, automatically interprets and displays results for the specimen.
The LIAISON NES Instrument is comprised of the following:
- Touchscreen User Interface
- Status LED Indicator
- Audio Speaker
- Barcode Scanner
The LIAISON NES software is a graphical user interface (GUI) application that is the end-user interface to the LIAISON NES Instrument. The software is installed in an embedded computer. The LIAISON NES software is responsible for providing the environment in which a user runs assays and obtains results.
The LIAISON NES instrument is intended to accept a cartridge, containing either a quality control (QC) or patient sample, to process and detect for the target nucleic acid.
The LIAISON NES FLU A/B, RSV & COVID-19 assay used on the LIAISON NES instrument is a real-time RT-PCR system that enables the direct amplification, detection, and differentiation of influenza A viral RNA, influenza B viral RNA, RSV RNA, and SARS-CoV-2 RNA directly from nasal swabs. Nasal swabs can be professionally collected by a healthcare provider or self-collected under the healthcare provider's supervision.
The LIAISON NES FLU A/B, RSV & COVID-19 assay consists of the LIAISON NES instrument, the LIAISON NES FLU A/B, RSV & COVID-19 Cartridge containing all the required PCR reagents, the NES Sample Vial containing sample release buffer, and the NES Swab for sample collection.
In the LIAISON NES FLU A/B, RSV & COVID-19 assay, fluorescent probes are used with corresponding forward and reverse primers to amplify influenza A, influenza B, RSV, and SARS-CoV-2, and internal control (IC) RNA. Conserved regions of influenza A viral RNA, influenza B viral RNA, RSV RNA, and SARS-CoV-2 RNA are targeted to identify the viruses in the specimen, while the internal control (IC) RNA is used to detect any PCR failures and/or inhibition.
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(146 days)
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(16 days)
Elecsys Anti-SARS-CoV-2 is an immunoassay intended for the in vitro qualitative detection of total antibodies to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in human serum and Li-heparin, K2-EDTA and K3-EDTA plasma collected on or after 15 days post-symptom onset. The test is intended as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e 601 immunoassay analyzer.
Elecsys Anti-SARS-CoV-2 is a qualitative, serological, double-antigen sandwich principle immunoassay to be used on the cobas e 601 analyzer with an 18-minute test time. Results are determined automatically by the software by comparing the electrochemiluminescence signal obtained from the reaction product of the sample with the signal of the cutoff value previously obtained by calibration. The Elecsys Anti‑SARS‑CoV-2 assay uses a recombinant protein representing the nucleocapsid (N) antigen for the determination of antibodies against SARS‑CoV‑2.
The reagent working solutions include: rackpack (kit placed on the analyzer)
- M Streptavidin-coated microparticles (transparent cap), 1 bottle, 12 mL: Streptavidin-coated microparticles 0.72 mg/mL; preservative.
- R1 SARS-CoV-2-Ag~biotin, (gray cap), 1 bottle, 16 mL: Biotinylated SARS‑CoV‑2‑specific recombinant antigen (E. coli) < 0.5 mg/L; HEPES^a) buffer 50 mmol/L, pH 7.7; preservative.
- R2 SARS-CoV-2 Ag~Ru(bpy) (black cap), 1 bottle, 16 mL: SARS‑CoV‑2‑specific recombinant antigen labeled with ruthenium complex < 0.5 mg/L; HEPES^(b) buffer 50 mmol/L, pH 7.7; preservative.
^(a) HEPES = [4-(2-hydroxyethyl)-piperazine]-ethane sulfonic acid
The Elecsys Anti-SARS-CoV-2 assay includes two liquid calibrators, which are packed with the test kit:
- ACOV2 Cal1 Negative calibrator 1 (white cap), 2 bottles of 0.67 mL: Human serum, non-reactive for anti‑SARS‑CoV‑2 antibodies; buffer; preservative.
- ACOV2 Cal2 Positive calibrator 2 (black cap), 2 bottles of 0.67 mL: Human serum, reactive for anti‑SARS‑CoV‑2 antibodies; buffer; preservative.
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(247 days)
The iHealth Flu A&B/COVID-19/RSV Rapid Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A, influenza B, SARS-CoV-2, and respiratory syncytial virus (RSV) protein antigens directly in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection. Symptoms of respiratory infections due to influenza, SARS-CoV-2, and RSV can be similar.
This test is for non-prescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged six (6) months or older.
All negative results are presumptive and should be confirmed with an FDA-cleared molecular assay when determined to be appropriate by a healthcare provider. Negative results do not rule out infection with influenza, SARS-CoV-2, RSV, or other pathogens.
Individuals who test negative and/or experience continued or worsening symptoms, such as fever, cough and/or shortness of breath, should seek follow-up care from their healthcare provider.
Positive results do not rule out co-infection with other respiratory pathogens and therefore do not substitute for a visit to a healthcare provider or appropriate follow-up.
The iHealth Flu A&B/COVID-19/RSV Rapid Test Pro is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A, influenza B, SARS-CoV-2, and respiratory syncytial virus (RSV) protein antigens directly in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection. Symptoms of respiratory infections due to influenza, SARS-CoV-2, and RSV can be similar.
This test is for use by individuals aged 14 years or older testing themselves, or adults testing individuals aged six (6) months or older.
All negative results are presumptive and should be confirmed with an FDA-cleared molecular assay when determined to be appropriate by a healthcare provider. Negative results do not rule out infection with influenza, SARS-CoV-2, RSV, or other pathogens.
Individuals who test negative and/or experience continued or worsening respiratory symptoms, such as fever, cough and/or shortness of breath, should seek follow-up care from their healthcare provider.
Positive results do not rule out co-infection with other respiratory pathogens.
Test results should not be used as the sole basis for treatment or other patient management decisions.
The iHealth Flu A&B/COVID-19/RSV Rapid Test and iHealth Flu A&B/COVID-19/RSV Rapid Test Pro (both versions hereafter also referred to as the candidate device) are lateral flow immunoassay device intended for the qualitative detection and differentiation of influenza A, influenza B, SARS-CoV-2, and respiratory syncytial virus (RSV) protein antigens.
Two versions are available for this over-the-counter (OTC) test: one is labeled for lay-user use and one is labeled for professional use, both with identical designs. The candidate device detects antigens from influenza A, influenza B, SARS-CoV-2, and RSV in anterior nasal swabs collected from individuals exhibiting signs and symptoms of respiratory infection within the first six (6) days of symptom onset, when tested at least twice over a three-day period with a minimum of 48 hours between tests.
The device is validated for testing direct anterior nasal samples (ANS) without the use of transport media. The device does not utilize biotin-streptavidin or avidin chemistry.
The test card contains two test strips, each with a nitrocellulose membrane, enclosed in a plastic case. One test strip has four lines: three test lines (Flu A, Flu B, and CoV) and a control line (Ctrl), while the other test strip has two lines: one test line (RSV) and a control line (Ctrl).
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(246 days)
iHealth Flu A&B/COVID-19 Rapid Test:
The iHealth Flu A&B/COVID-19 Rapid Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid protein directly in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection. Symptoms of respiratory infections due to SARS-CoV-2 and influenza can be similar.
This test is for non-prescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older.
All negative results are presumptive and should be confirmed with an FDA-cleared molecular assay when determined to be appropriate by a healthcare provider. Negative results do not rule out infection with influenza, SARS-CoV-2 or other pathogens.
Individuals who test negative and experience continued or worsening respiratory symptoms, such as fever, cough and/or shortness of breath, should seek follow-up care from their healthcare provider.
Positive results do not rule out co-infection with other respiratory pathogens and therefore do not substitute for a visit to a healthcare provider or appropriate follow-up.
iHealth Flu A&B/COVID-19 Rapid Test Pro:
The iHealth Flu A&B/COVID-19 Rapid Test Pro is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid protein directly in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection. Symptoms of respiratory infections due to SARS-CoV-2 and influenza can be similar.
This test is for use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older.
All negative results are presumptive and should be confirmed with an FDA-cleared molecular assay when determined to be appropriate by a healthcare provider. Negative results do not rule out infection with influenza, SARS-CoV-2 or other pathogens.
Individuals who test negative and experience continued or worsening respiratory symptoms, such as fever, cough and/or shortness of breath, should seek follow-up care from their healthcare provider.
Positive results do not rule out co-infection with other respiratory pathogens.
Test results should not be used as the sole basis for treatment or other patient management decisions.
The iHealth Flu A&B/COVID-19 Rapid Test and iHealth Flu A&B/COVID-19 Rapid Test Pro is a lateral flow immunoassay device intended for the qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B protein antigens.
This over the counter (OTC) test has two versions, one labeled for self-testing use, the (iHealth Flu A&B/COVID-19 Rapid Test), and one labeled for professional use (iHealth Flu A&B/COVID-19 Rapid Test Pro) (generically referred to as iHealth Flu A&B/COVID-19 Rapid Test for the remainder of this document). Both versions of the iHealth Flu A&B/COVID-19 Rapid Test have an identical general design and are intended to separately detect antigen from influenza A, influenza B, and SARS-CoV-2 in anterior nares swabs from individuals with signs and symptoms of respiratory infection within the first five (5) days of symptom onset. The iHealth Flu A&B/COVID-19 Rapid Test is validated for testing direct anterior nares samples (ANS) without transport media. The iHealth Flu A&B/COVID-19 Rapid Test does not use biotin-streptavidin/avidin chemistry.
The test card in the test kit is assembled with a test strip in a plastic housing that contains a nitrocellulose membrane with four lines: three test lines (Flu A line, Flu B line and SARS CoV-2 line) and a control line (Ctrl line).
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(219 days)
Thermo Scientific Oxoid Antimicrobial Susceptibility Test Discs are used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing. Used in a diagnostic workflow to aid clinicians in determining potential treatment options for patients suspected of having a microbial infection, these discs are intended to determine susceptibility against microorganisms for which specific drugs have been shown to be active both clinically and in vitro.
The Thermo Scientific Oxoid Gepotidacin Disc (10 microgram) GEP10 is intended to determine susceptibility of Enterobacterales, Staphylococcus saprophyticus, and Enterococcus faecalis to gepotidacin, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC). The Thermo Scientific Oxoid Gepotidacin Disc (10 microgram) GEP10 demonstrated acceptable performance to determine susceptibility to gepotidacin against the following microorganisms:
- Enterobacterales (Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Morganella morganii, Proteus mirabilis, and Providencia rettgeri)
- Staphylococcus saprophyticus
- Enterococcus faecalis
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(177 days)
The Flowflex® Plus Strep A Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of Group A Streptococcus antigen from throat swab specimens from symptomatic patients. The test is used to aid in the diagnosis of Group A Streptococcal infection. All negative test results should be confirmed by bacterial culture because negative results do not preclude infection with Group A Streptococcus and should not be used as the sole basis for treatment.
The Flowflex® Plus Strep A Rapid Test Strip is a rapid chromatographic immunoassay for the qualitative detection of Group A Streptococcus antigen from throat swab specimens from symptomatic patients. The test is used to aid in the diagnosis of Group A Streptococcal infection. All negative test results should be confirmed by bacterial culture because negative results do not preclude infection with Group A Streptococcus and should not be used as the sole basis for treatment.
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