(107 days)
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No
The document describes a standard ELISA assay and does not mention any AI or ML components in the device description or performance studies.
No
This device is an in vitro diagnostic (IVD) device used for detecting antibodies related to anthrax, not a therapeutic device. It aids in diagnosis rather than providing treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the kit is "an aid in the diagnosis of anthrax".
No
The device description clearly outlines a physical kit containing reagents, microwells, and requiring laboratory procedures (ELISA). It is a hardware-based diagnostic assay.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the kit is "intended for use in the qualitative detection of antibodies to the Protective Antigen (PA) protein of B. anthracis in human serum." This clearly indicates that the device is designed to be used in vitro (outside the body) to examine a human specimen (serum) for diagnostic purposes (as an aid in the diagnosis of anthrax or from recipients of anthrax vaccine).
- Device Description: The description details a laboratory test procedure (ELISA) performed on serum samples to detect specific antibodies. This is a hallmark of an in vitro diagnostic device.
- Performance Studies: The inclusion of performance studies like specificity and sensitivity, using human serum samples, further confirms its nature as a diagnostic test performed on biological specimens.
- Predicate Device: The mention of a "Preamendments modified agar diffusion assay" as a predicate device, which is also a laboratory test for detecting antibodies, reinforces the classification of this device as an IVD.
The device is designed to provide information about a person's health status (presence of antibodies to B. anthracis) by analyzing a sample of their body fluid (serum) in a laboratory setting. This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Immunetics® QuickELISA™ Anthrax-PA Kit is intended for use in the qualitative detection of antibodies to the Protective Antigen (PA) protein of B. anthracis in human serim. The assay should be used only on serum samples from individuals with a clinical history, signs or symptoms consistent with anthrax infection as an aid in the diagnosis of anthrax, or from recipients of anthrax vaccine.
- The diagnosis of anthrax infection must be made based on history, signs, symptoms, Exposure likelihood, and when possible other laboratory results in addition to the presence of antibodies to B. anthracis PA. Negative results in ELISA should not be used in isolation from other evidence to exclude anthrax.
- The assay has not been evaluated in individuals without clinical signs on symptoms who were probable exposures on information available to interpret cutaneous of innulnation antinentive test result for such individuals
- the meaning of a positive of negative the assay fluo not boon orded results with such infections are unknown.
- The minimum level of anti-PA antibodies that confers protection following vaccination is not known. This galue and protective immunity has not been established.
- The affinity and/or avidity of anti-PA IgG and IgM for the rPA antigen have not been determined with this assay.
Product codes (comma separated list FDA assigned to the subject device)
NRL
Device Description
The Immunetics® QuickELISA Anthrax-PA Kit allows qualitative detection in human serum of total antibodies to the Protective Antigen (PA) protein of B. anthracis, in a non-subtype specific, non-species specific microwell ELISA format. The PA toxin component of B. anthracis has been shown to elicit a detectable IgG response in naturally infected individuals and vaccine recipients . The assay is based on a single binding step, in which serum antibodies are incubated with a mixture of two rPA conjugates: Streptavidin-rPA and rPA-horseradish peroxidase (rPA-HRP). PA-specific, multivalent antibodies are able to form ternary complexes in which streptavidin-TPA and rPA-HRP are bound to different antigen combining sites on a single antibody molecule. The complexes are bound to the biotin-coated microplate via the streptavidin conjugate and detected via the HRP conjugate.
In the assay procedure Sample Diluent, serum samples and Conjugate mixture are added to wells and incubated. Unbound antibodies and Conjugate are removed by wash steps, and bound anti-PA antibodies and HRP Conjugate are detected by adding a chromogenic peroxidase substrate containing tetramethylbenzidine (TMB). A blue product is produced in wells where antibody has been bound to the solid phase. The color development reaction is quenched by addition of an acidic Stop Solution, which causes a change in color from blue to yellow, after which optical Absorbance at 450nm corrected by 620-650mm background subtraction is measured in each well using an ELISA microplate reader. Turn-around time for the test is approximately 35 minutes if agitation is used, or 70 minutes without agitation. While the assay provides a qualitative result when undiluted samples are tested, it may also be used to obtain semi-quantitative anti-PA IgG titer results when serial dilution data are collected for the scrum sample, in similar fashion to that described by U.S. Centers for Disease Control (CDC) Quinn, C.P. et al. Emerging Infectious Diseases 2002; 8(10):1103-1110.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Specificity
- Table 1.1: Normal Human Sera, Agitated Incubations (Standard Protocol) - 578 samples, 99.14% specificity (98.01 - 99.72 %).
- Table 1.2: Normal Human Sera, Agitated vs. Stationary Incubations (Agitated: 104 samples, 100% specificity (96.52 - 100%); Stationary: 100 samples, 100% specificity (96.38 - 100%)).
- Cross-Reactive Conditions (Interference Study Summary, Agitated Incubations (Standard Protocol))
- 225 samples, 99.56% specificity (97.55 - 99.99 %).
- Interference Study Results by Disease Condition Table 2.2: Included samples with ANA, EBV, HAV, HBV (HBsAg), HIV, H. pylori, Influenza (patients), Influenza (vaccinees), Legionella, M. pneumoniae, SLE (lupus), Rheumatoid Factor, RPR (syphilis). Specificity was 100% for most, 95.0% for RPR (syphilis).
- Sensitivity (Positive Serum Panels, Agitated Incubations (Standard Protocol))
- AVA Vaccinees: 49 samples, 100% sensitivity (92.75 - 100%).
- All Patients: 34 samples, 100% sensitivity (89.72 - 100%).
- Cutaneous Anthrax: 18 samples, 100% sensitivity (81.47 - 100%).
- Inhalational Anthrax: 16 samples, 100% sensitivity (79.41 - 100%).
- Sensitivity in CDC PA IgG-specific ELISA = 100 % in all above groups.
- Sensitivity data on sera from recipients of anthrax vaccines other than AVA was not determined.
- Sensitivity data on sera from anthrax patients infected by the gastrointestinal exposure route was not determined.
- Analytical Sensitivity (A-SENS) (PA IgG Reference Dilutions, Agitated Incubations (Std. Protocol))
- Determined for various ng/mL concentrations, with a calculated Assay Cutoff = 0.119.
- LL-95%-C-INT (REF dilution) vs. UL-95%-C-INT (NC) was ≤31.3 ng/mL.
- Best-fit 4-Parameter Curve Equation vs. Cutoff (Sensitivity @ Cutoff) was 229 ng/mL.
- The 1.0ug/mL PA IgG Reference Sample (REF-1) was used to establish Analytical Sensitivity and confirmed against CDC standard serum pool AVR414.
- Reproducibility
- Panel (n=16) included kit controls, strongly reactive, midrange reactive, and weakly reactive positive samples, a 100 µg/mL PA IgG Reference Sample (REF-1), and five negative samples.
- Inter-Assay Reproducibility, Agitated Incubations (Standard Protocol) Table 6.1 results provided for various samples.
- Inter-Lot Reproducibility, Agitated Incubations (Standard Protocol) Table 6.2 results provided for various samples.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Specificity, Sensitivity, Analytical Sensitivity, Reproducibility
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
The QuickELISA Anthrax-PA Kit is substantially equivalent to the Preamendments modified agar diffusion assay distributed by the U.S. Army Biological Laboratories since 1964.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.3045 In vitro diagnostic device for
Bacillus spp. detection.(a)
Identification. An in vitro diagnostic device forBacillus species (spp.) detection is a prescription device used to detect and differentiate amongBacillus spp. and presumptively identifyB. anthracis and otherBacillus spp. from cultured isolates or clinical specimens as an aid in the diagnosis of anthrax and other diseases caused byBacillus spp. This device may consist ofBacillus spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to presumptively identify bacillus-like organisms in clinical specimens; bacteriophage used for differentiatingB. anthracis from otherBacillus spp. based on susceptibility to lysis by the phage; or antigens used to identify antibodies toB. anthracis (anti-toxin and anti-capsular) in serum. Bacillus infections include anthrax (cutaneous, inhalational, or gastrointestinal) caused byB. anthracis, and gastrointestinal disease and non-gastrointestinal infections caused byB. cereus. (b)
Classification. Class II (special controls). The special controls are set forth in FDA's special controls guideline document entitled “In Vitro Diagnostic Devices forBacillus spp. Detection; Class II Special Controls Guideline for Industry and Food and Drug Administration Staff.” For availability of the guideline document, see § 866.1(e).(c)
Restriction on Distribution. The distribution of these devices is limited to laboratories that follow public health guidelines that address appropriate biosafety conditions, interpretation of test results, and coordination of findings with public health authorities.(d)
Restriction on Use. The use of this device is restricted to prescription use and must comply with the following:(1) The device must be in the possession of:
(i)(A) A person, or his agents or employees, regularly and lawfully engaged in the manufacture, transportation, storage, or wholesale or retail distribution of such device; or
(B) A practitioner, such as a physician, licensed by law to use or order the use of such device; and
(ii) The device must be sold only to or on the prescription or other order of such practitioner for use in the course of his professional practice.
(2) The label of the device shall bear the statement “Caution: Federal law restricts this device to sale by or on the order of a ____”, the blank to be filled with the word “physician” or with the descriptive designation of any other practitioner licensed by the law of the State in which he practices to use or order the use of the device.
(3) Any labeling, as defined in section 201(m) of the Federal Food, Drug, and Cosmetic Act, whether or not it is on or within a package from which the device is to be dispensed, distributed by, or on behalf of the manufacturer, packer, or distributor of the device, that furnishes or purports to furnish information for use of the device contains adequate information for such use, including indications, effects, routes, methods, and frequency and duration of administration and any relevant hazards, contraindications, side effects, and precautions, under which practitioners licensed by law to employ the device can use the device safely and for the purposes for which it is intended, including all purposes for which it is advertised or represented. This information will not be required on so-called reminder-piece labeling which calls attention to the name of the device but does not include indications or other use information.
(4) All labeling, except labels and cartons, bearing information for use of the device also bears the date of the issuance or the date of the latest revision of such labeling.
0
Premarket Notification 510(k) February 13, 2004
510(k) Summary
Submitted by:
JUN 0 3 2004
Immunetics, Inc. 27 Drydock Avenue Boston, MA 02210-2377
Contact Person:
Andrew E. Levin, Ph.D. President and CEO 617-896-9100
Date of Preparation:
February 13, 2003
Name and Address of Owner/Operator and Manufacturer
Immunetics, Inc. 27 Drydock Avenue Boston, MA 02210-2377
Product Name
Trade Name: QuickELISA Anthrax-PA Kit
Common Name: B. anthracis QuickELISA Anthrax-PATM Kit
Claim of Substantial Equivalence
The QuickELISA Anthrax-PA Kit is substantially equivalent to the Preamendments modified agar diffusion assay distributed by the U.S. Army Biological Laboratories since 1964. Both products utilize antigens to detect antibodies formed against B. anthracis.
Description
The Immunetics® QuickELISA Anthrax-PA Kit allows qualitative detection in human serum of total antibodies to the Protective Antigen (PA) protein of B. anthracis, in a non-subtype specific, non-species specific microwell ELISA format. The PA toxin component of B. anthracis has been shown to elicit a detectable IgG response in naturally infected individuals and vaccine recipients . The assay is based on a single binding step, in which serum antibodies are incubated with a mixture of two rPA conjugates: Streptavidin-rPA and rPA-horseradish peroxidase (rPA-HRP). PA-specific, multivalent antibodies are able to form ternary
1
complexes in which streptavidin-TPA and rPA-HRP are bound to different antigen combining sites on a single antibody molecule. The complexes are bound to the biotin-coated microplate via the streptavidin conjugate and detected via the HRP conjugate.
In the assay procedure Sample Diluent, serum samples and Conjugate mixture are added to wells and incubated. Unbound antibodies and Conjugate are removed by wash steps, and bound anti-PA antibodies and HRP Conjugate are detected by adding a chromogenic peroxidase substrate containing tetramethylbenzidine (TMB). A blue product is produced in wells where antibody has been bound to the solid phase. The color development reaction is quenched by addition of an acidic Stop Solution, which causes a change in color from blue to yellow, after which optical Absorbance at 450nm corrected by 620-650mm background subtraction is measured in each well using an ELISA microplate reader. Turn-around time for the test is approximately 35 minutes if agitation is used, or 70 minutes without agitation. While the assay provides a qualitative result when undiluted samples are tested, it may also be used to obtain semi-quantitative anti-PA IgG titer results when serial dilution data are collected for the scrum sample, in similar fashion to that described by U.S. Centers for Disease Control (CDC) Quinn, C.P. et al. Emerging Infectious Diseases 2002; 8(10):1103-1110.
Intended Use
The Immunetics® Quick ELISA Anthrax-PA Kit is intended for use in the presumptive detection of IgG and IgM antibodies to the Protective Antigen (PA) toxin protein of B. anthracis in human serum. The assay should only be used on serum samples from individuals with a clinical history, signs or symptoms consistent with anthrax infection; recipients of a licensed anthrax vaccine; or those with presumed contact with anthrax spores or vegetative bacilli. The diagnosis of anthrax infection must be made based on history, signs (such as raised bump skin infection with a characteristic black area that develops in the center), symptoms (such as fever or flu-like symptoms, non-productive cough, malaise, sore throat and/or regional lymphadenopathy) and when possible other laboratory data, in addition to the presence of antibodies to B. anthracis PA. Negative results in ELISA should not be used in isolation from other evidence to exclude anthrax infection.
2
Summary of Performance
1. Specificity
| Table 1.1 | Normal Human Sera, Agitated Incubations (Standard Protocol) | |||
|---|---|---|---|---|
| Clear Meller of Sheep and Children and Children and Childer of the Market Collection of the Series and Children and | ||||
| OuickELISA Anthrax-PA | રક્ષરે | 578 | 99.14 % | 98.01 - 99.72 % |
| 1 0 0 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 | ||||
| · NOYTE: | (IN nublished recults (151) 2017) archived dots on upcelated camples |
NOTE:
| Table 1.2 | Normal Human Sera, Agitated vs. Stationary Incubations | |||
|---|---|---|---|---|
| Commonth Minimal Services of Children Company of Children Children Children Children Children Children C | ||||
| Stationary | 100 | 1 (AC) | 100 % | 96_38 - 100 % |
| Agitated | 104 | 104 | 100 % | 96.52 - 100 % |
The specificity reported in the non-endemic normal population shown in Tables 1.1 and 1.2 above is performance data intended as background information, but does not necessarily represent specificity in the population of intended use.
2. Cross-Reactive Conditions
Table 2.1 Interference Study Summary, Agitated Incubations (Standard Protocol)
| 14 1300 0000000 000 000 000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 | ||||
|---|---|---|---|---|
| QuickELISA Anthrax-PA | 225 | 224 | 99.56 % | 97.55 - 99.99 % |
| CHOPING BLISH - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 | ||||
| 'NOTE: | CDC published results (JEID 2002); archived data on unrelated samples |
Interference Study Results by Disease Condition Table 2.2
| ANA (anti-nuclear Ab) | 21 | 0 | 21 | 100 % |
|---|---|---|---|---|
| EBV | 20 | 0 | 20 | 100 % |
| HAV | 4 | 0 | 4 | 100 % |
| HBV (HBsAg) | 20 | 0 | 20 | 100 % |
| HIV | 20 | 0 | 20 | 100 % |
| H. pylori | 26 | 0 | 26 | 100 % |
| Influenza (patients) | 10 | 0 | 10 | 100 % |
| Influenza (vaccinees) | 20 | 0 | 20 | 100 % |
| Legionella | 4 | 0 | 4 | 100 % |
| M. pneumoniae | 20 | 0 | 20 | 100 % |
| SLE (lupus) | 20 | 0 | 20 | 100 % |
| Rheumatoid Factor | 20 | 0 | 20 | 100 % |
| RPR (syphilis) | 20 | 1 | 19 | 95.0 % |
3
3. Sensitivity
| Table 3.1 Positive Serum Panels, Agitated Incubations (Standard Protocol) | |||||
|---|---|---|---|---|---|
| AVA Vaccinees | 49 | 49 | 100 % | 92.75 - 100 % | 92.75 - 100 % |
| All Patients | 34 | 19 | 100 % | 89.72 - 100 % | 82.35 - 100 % |
| Cutaneous Anthrax | 18 | 13 | 100 % | 81.47 - 100 % | 75.29 - 100 % |
| Inhalational Anthrax | 16 | 6 | 100 % | 79.41 - 100 % | 54.07 - 100 % |
Sensitivity in CDC PA IgG-specific ELISA = 100 % in all above groups
Sensitivity data on sera from recipients of anthrax vaccines other than AVA (Bioport Corporation, Lansing, MI) was not determined, and could potentially be different than that reported above in Table 3.1 for AVA recipients. Similarly, sensitivity data on sera from anthrax patients infected by the gastrointestinal exposure route was not determined, and could potentially be different than that reported above in Table 3.1 for patients infected by the cutaneous and inhalational exposure routes.
4. Analytical Sensitivity (A-SENS)
| Table 4.1 | PA IgG Reference Dilutions, Agitated Incubations (Std. Protocol) | |||
|---|---|---|---|---|
| 1000 ng/mL | 0.322 | 3.17 | 0.3322 | 0.3118 |
| 500 ng/mL | 0.178 | 1.39 | 0.1804 | 0.1756 |
| 250 ng/mL | 0.100 | 2.13 | 0.1021 | 0.0979 |
| 125 ng/mL | 0.058 | 1.60 | 0.0589 | 0.0571 |
| 62.5 ng/mL | 0.038 | 2.02 | 0.0387 | 0.0373 |
| 31.3 ng/mL | 0.027 | 3.43 | 0.0278 | 0.0262 |
| 15.6 ng/mL | 0.026 | 9.62 | 0.0329 | 0.0191 |
| 0 ng/mL (NC) | 0.020 | 13.36 | 0.0222 | 0.0178 |
| LL-95%-C-INT (REF dilution) vs. UL-95%-C-INT (NC) | ≤31.3 ng/mL | |||
| Best-fit 4-Parameter Curve Equation vs. Cutoff (Sensitivity @ Cutoff) | 229 ng/mL |
Assay Cutoff = 0.119
UL-95%-C-INT = Upper Limit of 95 % Confidence Interval
LL-95%-C-INT = Lower Limit of 95 % Confidence Interval
The 1.0ug/mL PA IgG Reference Sample (REF-1) used to establish Analytical Sensitivity was prepared from CDC standard serum pool designated AVR414 (described in JEID, 2002), and its activity was confirmed in a parallel serial dilution study against AVR414.
4
5. Specificity, Cross-Reactivity & Sensitivity Histogram Summary
Image /page/4/Figure/3 description: The image is a histogram titled "QuickELISA Anthrax-PA Results Net A450 Histograms". The histogram compares the frequency of "Normal Human Sera" and "All Interference Sera" across different "Net A450 Bin" values. The x-axis represents the "Net A450 Bin" values, ranging from 0.01 to 4, while the y-axis represents the frequency, ranging from 0 to 600.
Image /page/4/Figure/4 description: The image is a bar graph comparing the frequency of AVA vaccinees, cutaneous patients, and inhalational patients. The x-axis is labeled "Net A450 Bin" and ranges from 0.01 to 4. The y-axis is labeled "Frequency" and ranges from 0 to 40. The graph shows that the frequency of cutaneous patients is highest at Net A450 Bin 4, with a frequency of approximately 38.
5
Image /page/5/Figure/2 description: The image contains two histograms titled "QuickELISA Anthrax-PA Results S/CO Histograms". The first histogram shows the frequency of "Normal Human Sera" and "All Interference Sera" with respect to the S/CO Bin. The second histogram shows the frequency of "AVA Vaccinees", "Cutaneous Patients", and "Inhalational Patients" with respect to the S/CO Bin. Both histograms show the frequency on the y-axis and the S/CO Bin on the x-axis.
6
6. Reproducibility
Reproducibility was tested on a panel (n = 16) consisting of the kit controls (Low Positive Control, Positive Control and Negative Control); three strongly reactive (HiP)-HiP3, as shown below), one midrange reactive (MeP1) and three weakly reactive (LoP1-LoP3) positive samples; a 100 µg/mL PA IgG Reference Sample (REF-1), to confirm analytical sensitivity as ≤ 1 ug/plL; and five negative samples (N1-N5). Reproducibility testing was conducted for documentation of intraassay, inter-assay, inter-site, inter-lot reproducibility and analytical sensitivity of the QuickELIS A Anthrax-PA kit; the inter-lot reproducibility study results are shown in Table 6.1 below.
Inter-Assay Reproducibility, Agitated Incubations (Standard Protocol) Table 6.1
| PC | 2.0 | 2.191 | 3.6 | 2.228 | 3.1 | 2.279 | 6.5 |
|---|---|---|---|---|---|---|---|
| Low PC | 1.5 | 0.850 | 3.6 | 0.854 | 3.1 | 0.875 | 5.5 |
| HiP1 | 0.4 | 3.794 | 7.0 | 3.810 | 6.4 | 3.824 | 5.3 |
| HiP2 | 0.5 | 3.812 | 6.2 | 3.846 | 4.8 | 3.833 | 5.7 |
| HiP3 | 2.0 | 3.870 | 5.1 | 3.720 | 5.7 | 3.829 | 4.8 |
| LoP1 | 2.5 | 2.224 | 6.5 | 2.280 | 8.6 | 2.170 | 3.1 |
| LoP2 | 3.0 | 0.604 | 11.0 | 0.629 | 10.4 | 0.594 | 2.2 |
| LoP3 | 6.4 | 0.457 | 9.0 | 0.459 | 13.9 | 0.410 | 1.9 |
| REF-1 | 8.4 | 0.324 | 8.5 | 0.383 | 14.8 | 0.357 | 2.7 |
| MeP1 | 7.8 | 2.944 | 7.7 | 2.968 | 10.1 | 2.575 | 2.4 |
Table 6.2
Inter-Lot Reproducibility, Agitated Incubations (Standard Protocol)
| PC | 11.2 | 2.565 | 1.9 | 2.736 | 4.6 | 2.191 | 3.6 |
|---|---|---|---|---|---|---|---|
| Low PC | 10.2 | 0.693 | 1.1 | 0.762 | 4.7 | 0.850 | 3.6 |
| HiP1 | 2.2 | 3.918 | 5.0 | 3.759 | 7.2 | 3.794 | 7.0 |
| HiP2 | 0.9 | 3.745 | 5.9 | 3.781 | 5.4 | 3.812 | 6.2 |
| HiP3 | 1.7 | 3.885 | 4.5 | 3.767 | 6.3 | 3.870 | 5.1 |
| LoP1 | 22.6 | 1.410 | 12.6 | 1.777 | 10.9 | 2.224 | 6.5 |
| LoP2 | 26.3 | 0.366 | 13.4 | 0.430 | 12.4 | 0.604 | 11.0 |
| LoP3 | 20.5 | 0.314 | 10.7 | 0.341 | 13.3 | 0.457 | 9.0 |
| REF-1 | 15.7 | 0.238 | 12.7 | 0.269 | 11.9 | 0.324 | 8.5 |
| MeP1 | 16.0 | 2.136 | 5.3 | 2.513 | 7.2 | 2.944 | 7.7 |
7
Conclusions
Based on the clinical performance results presented, this device has been shown to be safe and effective for the intended use in the presumptive detection of IgG and IgM antibodies to the Protective Antigen (PA) toxin protein of B. anthracis in human serum from vaccinated and unvaccinated populations.
8
Image /page/8/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with three horizontal lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged around the eagle symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 0 3 2004
Andrew E. Levin, Ph.D. President and Chief Executive Officer Immunetics, Inc. 27 Drydock Avenue Boston, MA 02210-2377
K040407 Re:
Trade/Device Name: QuickELISA Anthrax-PATM Kit Regulation Number: Unclassified Product Code: NRL Dated: May 25, 2004 Received: May 27, 2004
Dear Dr. Levin:
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.
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).
9
Page 2
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 premaince hourse 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, rr yourstions 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,
Salartys
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
10
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
QuickELISA Anthrax-PA™ Kit Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Immunetics® QuickELISA™ Anthrax-PA Kit is intended for use in the qualitative The Immunelics - QuickLLOA- Antigen (PA) protein of B. anthrasis in human
detection of antibodies to the Protective Antigen (PA) protein of B. anthranisms a serim. The assay should be used only on serum samples from individuals with a serium. The assay should be used only on consistent with anthrax infection as an aid in the diagnosis of anthrax, or from recipients of anthrax vaccine.
- The diagnosis of anthrax infection must be made based on history, signs, ◆ ◆ The diagnosure likelihood, and when possible other laborative rooults in symptoms, Exposure finCimood, and inton partiracis PA. Negative results in addition to the presence of antiation from other evidence to exclude anthrax.
- The assay has not been evaluated in individuals without clinical signs on � The assay nas not been ovaliation in the subsequently developed Symptoms who were probamou oxposures on information available to interpret cutaneous of innulation antinentive test result for such individuals
- the meaning of a positive of negativens from patients infected by the � The assay fluo not boon orded results with such infections are unknown.
- The minimum level of anti-PA antibodies that confers protection following � The minimum is not known. The QuickElisa measures total antibody and the vaccination is not known. This galue and protective immunity has not been established.
- The affinity and/or avidity of anti-PA IgG and IgM for the rPA antigen have not � been determined with this assay.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Division Sign-Off
| Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) |
|---|
| Office of In Vitro Diagnostic |
| Device Evaluation and Safety |
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