(342 days)
Not Found
No
The device description details a standard immunochromatographic assay (lateral flow test) that relies on chemical reactions and visual interpretation of lines. There is no mention of any computational analysis, algorithms, or learning processes that would indicate the use of AI or ML.
No.
The document explicitly states that the device is an "immunochromatographic test system for the qualitative or semi-quantitative detection of capsular polysaccharide antigens" which "can aid in the diagnosis of Cryptococcosis." It is a diagnostic tool, not a device intended for treating or rehabilitating a medical condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device "can aid in the diagnosis of Cryptococcosis."
No
The device description clearly outlines a physical dipstick immunochromatographic assay that uses specimen wicking and immobilized antibodies to detect antigens, which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's a "test system for the qualitative or semi-quantitative detection of capsular polysaccharide antigens of Cryptococcus species complex... in serum." This clearly indicates it's used to examine specimens derived from the human body (serum) to provide information for diagnostic purposes (aiding in the diagnosis of Cryptococcosis).
- Device Description: The description details a "dipstick sandwich immunochromatographic assay" that detects "cryptococcal antigen in serum." This describes a laboratory test performed on a biological sample.
- Performance Studies: The document includes detailed performance studies like analytical sensitivity, analytical specificity, method comparison with other diagnostic tests (EIA, Culture/India Ink, Latex Agglutination), and a predicate device comparison. These are all characteristic of the validation required for an IVD.
- Key Metrics: The inclusion of metrics like sensitivity, specificity, and percent agreement further confirms its role as a diagnostic test.
- Intended User/Care Setting: It is described as a "prescription-use laboratory assay," indicating it is intended for use in a laboratory setting by trained personnel, which is typical for many IVDs.
Based on the provided information, the CrAg Lateral Flow Assay fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CrAg Lateral Flow Assay is an immunochromatographic test system for the qualitative or semi-quantitative detection of capsular polysaccharide antigens of Cryptococcus species complex (Cryptococcus neoformans and Cryptococcus gatti) in serum.
The CrAg Lateral Flow Assay is a prescription-use laboratory assay, which can aid in the diagnosis of Cryptococcosis.
Product codes (comma separated list FDA assigned to the subject device)
GMD
Device Description
The CrAg Lateral Flow Assay is a dipstick sandwich immunochromatographic assay, which detects cryptococcal antigen in serum. For the qualitative procedure, specimens are diluted 1:2 in 1x Specimen Diluent and analyzed. For the semi-quantitative procedure, specimens are diluted 1:5 in 1x Specimen Diluent followed by 1:2 serial dilutions. All dilutions are then analyzed as in the qualitative procedure. Specimens are placed into an appropriate reservoir, such as a test tube or microtiter plate, and the lateral flow device is then placed into the reservoir allowing the specimen to come into contact with the test membrane. The test uses specimen wicking to capture gold-conjugated, anti-cryptococcal monoclonal antibodies and gold-conjugated control antibodies that are deposited onto a membrane. If cryptococcal antigen is present in the specimen, it binds to the gold-conjugated, anti-cryptococcal antibodies. The gold-labeled antibody-antigen complex will continue to wick up the membrane where it will interact with the Test Line (T). The Test Line is immobilized anti-cryptococcal monoclonal antibodies. If the specimen contains cryptococcal antigen, a sandwich is created with the gold-labeled antibodies and the immobilized antibodies, causing a visible line to develop at the test line site (T). If proper flow occurs and the reagents are reactive at the time of use, the wicking of any specimen, positive or negative, will cause the gold-conjugated control goat IgG antibody to move to the Control Line (C) which is immobilized bovine anti-goat IgG antibody. The immobilized anti-goat antibody will bind to the gold-conjugated goat IgG Control antibody and will cause a visible line to develop (C). A positive test result will create two lines, while a negative test result will create one line (Figure 1). If the control line fails to develop a line, then the test is not valid.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
prescription-use laboratory assay
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- A. Precision Studies (Repeatability & Reproducibility)
- Sample: Serum.
- Samples were analyzed on the CrAg Lateral Flow Assay in triplicate on five different days, at three different sites with a total of five different operators, on one lot, according to EP5-A2.
- Overall percent positive for Med. Pos was 100% (75/75), for Low Pos was 100% (75/75).
- Overall percent negative for High Neg was 97% (73/75), for Neg was 100% (75/75).
- B. Analytical Sensitivity (lower limits of the assay/analytical cut-off)
- The analytical cut-off is 1.25ng/ml.
- C. Analytical Specificity (cross-reactivity)
- A total of 118 serum specimens were tested in triplicate.
- Pathologies with 0% positive: Penicilliosis (0/5), Sporothrichosis (0/6), HAMA (0/5), Syphilis (0/10), Rubella (0/5), Mycoplasmosis (0/10), Toxoplasmosis (0/7), CMV (0/10), Blastomycosis (0/10), Coccidiomycosis (0/10), Histoplasmosis (0/10), Candidiasis (0/10), Rheumatoid Factor (0/10).
- Aspergillus GM+ showed 10% positive (1/10).
- Cross-reactivity was assessed by testing crude culture filtrate antigens. At high concentrations (>0.1 mg/ml), antigens from Paracoccidiodes brasiliensis exhibited some cross-reactivity. Antigens from Aspergillus terreus, Aspergillus fumigatus, Aspergillus niger, and Aspergillus flavus did not exhibit cross-reactivity.
- Interference testing performed on five icteric, five hemolyzed, and five lipemic serum specimens. All spiked specimens were positive, unspiked were negative, indicating these types of serum specimens do not interfere.
- Effect of pronase: No effect on CrAg LFA.
- E. High Dose Hook Effect
- Serum specimens with a cryptococcal antigen concentration higher than 200ug/ml can produce a high dose hook effect and therefore may produce a false negative result.
- F. Method Comparison
- Cryptococcal Antigen EIA comparison: A panel of 197 serum specimens.
- CrAg Lat Flow (+) vs EIA (+): 96
- CrAg Lat Flow (+) vs EIA (-): 7
- CrAg Lat Flow (-) vs EIA (+): 0
- CrAg Lat Flow (-) vs EIA (-): 94
- % Agreement Positive: 100% (95% CI: 96-100%)
- % Agreement Negative: 93% (95% CI: 86-97%)
- Culture/India Ink (Gold Standards) comparison (Includes both prospective and retrospective specimens):
- Sensitivity: 100% (95% CI: 96.0%-100%)
- Specificity: 100% (95% CI: 97.0%-100%)
- Predicate Device Comparison - Latex-Cryptococcal Antigen Detection System (K791382). A panel of 197 serum specimens.
- CrAg LFA (+) vs Latex (+): 101
- CrAg LFA (+) vs Latex (-): 2
- CrAg LFA (-) vs Latex (+): 0
- CrAg LFA (-) vs Latex (-): 94
- % Agreement Positive: 100% (95% CI: 96-100%)
- % Agreement Negative: 98% (95% CI: 93-99%)
- Semi-Quantitative Serum: 62 positive serum specimens were analyzed. Data showed strong correlation between CrAg Lateral Flow Assay and IMMY Latex-Cryptococcus Antigen Detection System (R2 = 0.905).
- Cryptococcal Antigen EIA comparison: A panel of 197 serum specimens.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Analytical Sensitivity: The analytical cut-off is 1.25ng/ml.
- Method Comparison with Cryptococcal Antigen EIA:
- % Agreement Positive: 100%
- % Agreement Negative: 93%
- Method Comparison with Culture/India Ink (Gold Standards):
- Sensitivity: 100%
- Specificity: 100%
- Method Comparison with Predicate Device (K791382):
- % Agreement Positive: 100%
- % Agreement Negative: 98%
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.
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
§ 866.3165
Cryptococcus neoformans serological reagents.(a)
Identification. Cryptococcus neoformans serological reagents are devices that consist of antigens used in serological tests to identify antibodies toCryptococcus neoformans in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) and are used to identifyCryptococcus neoformans directly from clinical specimens or from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of cryptococcosis and provides epidemiological information on this type of disease. Cryptococcosis infections are found most often as chronic meningitis (inflammation of brain membranes) and, if not treated, are usually fatal.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
0
K.102286.
510(k) Premarket Notification CrAg Lateral Flow Assay
510(k) Summary CrAg Lateral Flow Assay
JUL 2 0 2011
This 510(k) summary is submitted in accordance with 21 CFR §807.92
| Owner: | Immuno-Mycologics, Inc.
2700 Technology Place
Norman, OK 73071
Tel: 405-360-4669
Fax: 405-364-1058
Contact: Dr. Sean K. Bauman, President & CEO
Sean-Bauman@immy.com |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prepared: | July 18, 2011 |
| Trade Name: | CrAg Lateral Flow Assay |
| Common Name: | Cryptococcal Antigen Lateral Flow Immunoassay |
| Regulation: | 866.3165 |
| Predicate Device: | Immuno-Mycologics' Latex-Cryptococcus Antigen Detection System
510(k) # K791382 |
| Intended Use: | The CrAg Lateral Flow Assay is an immunochromatographic test system
for the qualitative or semi-quantitative detection of capsular
polysaccharide antigens of Cryptococcus species complex (Cryptococcus
neoformans and Cryptococcus gatti) in serum.
The CrAg Lateral Flow Assay is a prescription-use laboratory assay, which
can aid in the diagnosis of Cryptococcosis. |
Device Description:
Explanation:
Detection of cryptococcal antigen in serum has been used for over forty years to aid in the diagnosis of cryptococcosis with very high sensitivity and specificity (9,14,15). Current guidelines for the management of cryptococcal disease partially base treatment recommendations on cryptococcal antigen presence and more specifically on cryptococcal antigen titers (16).
Cryptococcosis is caused by both species of the Cryptococcus species complex (Cryptococcus neoformans and Cryptococcus gotti) (5,6,12,13). Individuals with impaired cell-mediated immune (CMI) function due to acquired immunodeficiency syndrome (AIDS) (19),
Rev. 07/18/2011
1
lymphoproliferative disorders (18), steroid therapy (8), and organ transplantation (7) are at increased risk of cryptococcosis. AIDS accounts for 80-90% of cryptococcal infections (11). The incidence of cryptococcosis in AIDS patients in the United States is estimated to be 5-10% (11), while the incidence of cryptococcosis in other parts of the world, such as Africa, is as high as 30% (3). Cryptococcosis is the fourth most common opportunistic, life-threatening infection among AIDS patients (10).
Description:
The CrAg Lateral Flow Assay is a dipstick sandwich immunochromatographic assay, which detects cryptococcal antigen in serum. For the qualitative procedure, specimens are diluted 1:2 in 1x Specimen Diluent and analyzed. For the semi-quantitative procedure, specimens are diluted 1:5 in 1x Specimen Diluent followed by 1:2 serial dilutions. All dilutions are then analyzed as in the qualitative procedure. Specimens are placed into an appropriate reservoir, such as a test tube or microtiter plate, and the lateral flow device is then placed into the reservoir allowing the specimen to come into contact with the test membrane. The test uses specimen wicking to capture gold-conjugated, anti-cryptococcal monoclonal antibodies and gold-conjugated control antibodies that are deposited onto a membrane. If cryptococcal antigen is present in the specimen, it binds to the gold-conjugated, anti-cryptococcal antibodies. The gold-labeled antibody-antigen complex will continue to wick up the membrane where it will interact with the Test Line (T). The Test Line is immobilized anti-cryptococcal monoclonal antibodies. If the specimen contains cryptococcal antigen, a sandwich is created with the gold-labeled antibodies and the immobilized antibodies, causing a visible line to develop at the test line site (T). If proper flow occurs and the reagents are reactive at the time of use, the wicking of any specimen, positive or negative, will cause the gold-conjugated control goat IgG antibody to move to the Control Line (C) which is immobilized bovine anti-goat IgG antibody. The immobilized anti-goat antibody will bind to the gold-conjugated goat IgG Control antibody and will cause a visible line to develop (C). A positive test result will create two lines, while a negative test result will create one line (Figure 1). If the control line fails to develop a line, then the test is not valid.
Image /page/1/Figure/5 description: The image shows a diagram of a cryptococcal antigen test. The diagram illustrates the components of the test, including the sample application area, gold-conjugated control antibodies, test line, and control line. It also shows the results of a positive and negative test. The positive test shows the presence of cryptococcal antigen, while the negative test shows the absence of cryptococcal antigen.
Figure 1. CrAg Lateral Flow Assay Schematic
Rev: 07/18/2011
2
Technological Characteristics Summary
A comparison between the Cryptococcal Antigen Lateral Flow Immunoassay and the Latex-Cryptococcus Antigen Detection System is presented in Table 1.
| SIMILARITIES | |||
|---|---|---|---|
| Feature | Cryptococcal Antigen Lateral Flow Assay | Latex-Cryptococcus Antigen Detection System (K791382) | |
| Intended Use | Test for the qualitative or semi-quantitative detection of capsular polysaccharide antigens of Cryptococcus in serum | Test for the qualitative or semi-quantitative detection of capsular polysaccharide antigens of Cryptococcus in serum | |
| Intended Use Indication For Use | Prescription-use laboratory assay, which can aid in the diagnosis of cryptococcosis | Prescription-use laboratory assay, which can aid in the diagnosis of cryptococcosis | |
| Device Description | |||
| Sample Matrix | Serum | Serum | |
| Instruments | None | None | |
| Detection Antibody | Anti-cryptococcal antibody | Anti-cryptococcal antibody | |
| DIFFERENCES | |||
| Feature | Cryptococcal Antigen Lateral Flow Assay | Latex-Cryptococcus Antigen Detection System | |
| Intended Use | Serum only | Serum and CSF | |
| Intended Use Indication For Use | No differences | No differences | |
| Device Description | |||
| Assay Principle | Lateral flow assay | Latex agglutination | |
| Assay Components | Specimen diluent, lateral flow strips, built-in control, gold conjugated antibodies | Positive control, negative control, latex cards, latex conjugated antibodies | |
| Serum Pre-Treatment | Serum dilution | Pronase with pronase inhibitor | |
| CSF Pre-Treatment | None | Boil | |
| Detection Antibodies | Gold-conjugated anti-cryptococcal monoclonal antibodies | Latex-conjugated anti-cryptococcal polyclonal antibodies | |
| Storage Requirements | 20-25°C | 4°C ± 2° |
Table 1. Comparison with Predicate Device
Performance Summary
- A. Precision Studies (Repeatability & Reproducibility)
Serum:
Repeatability and reproducibility with serum specimens were determined by spiking a serum specimen pool that was negative by the IMMY Latex-Cryptococcus Antigen Detection
3
System with cryptococcal antigen at four concentrations: Negative, high negative (C,), low positive (near Cgs), and medium positive. The samples were analyzed on the CrAg Lateral Flow Assay in triplicate on five different days, at three different sites with a total of five different operators, on one lot, according to EP5-A2. One site was internal (Site 1) and the remaining two were a US reference laboratory (Site 2) and a US hospital laboratory (Site 3). For repeatability, percent positive and percent negative detected were calculated for each site (Table 2). For reproducibility, overall percent positive and percent negative detected were calculated by combining the data from all three sites (last two rows of Table 2).
| Serum | ||||||||
|---|---|---|---|---|---|---|---|---|
| Sample | 1 | 2 | 3 | 4 | ||||
| Med. Pos | Low Pos | High Neg | Neg | |||||
| Neg/Pos | - | + | - | + | - | + | - | + |
| Site 1 | 0 | 30 | 0 | 30 | 28 | 2 | 30 | 0 |
| Percent % | 0 | 100 | 0 | 100 | 93 | 7 | 100 | 0 |
| Site 2 | 0 | 30 | 0 | 30 | 30 | 0 | 30 | 0 |
| Percent % | 0 | 100 | 0 | 100 | 100 | 0 | 100 | 0 |
| Site 3 | 0 | 15 | 0 | 15 | 15 | 0 | 15 | 0 |
| Percent % | 0 | 100 | 0 | 100 | 100 | 0 | 100 | 0 |
| Total No. | 0 | 75 | 0 | 75 | 73 | 2 | 75 | 0 |
| Percent % | 0 | 100 | 0 | 100 | 97 | 3 | 100 | 0 |
| Table 2. Serum Repeatability at 3 Different Sites | |||||
|---|---|---|---|---|---|
| -- | -- | --------------------------------------------------- | -- | -- | -- |
-
B. Analytical Sensitivity (lower limits of the assay/analytical cut-off)
Analytical sensitivity for the CrAg Lateral Flow Assay was estimated by running varying concentrations of cryptococcal antigen diluted in Lateral Flow (LF) Specimen Diluent, according to EP12-A2. The concentration where 50% of the results were positive and 50% of the results were negative determined our analytical cut-off. The analytical cut-off is 1.25ng/ml. -
C. Analytical Specificity (cross-reactivity)
Analytical specificity for the CrAg Lateral Flow Assay was determined by running potentially cross-reacting medical conditions unrelated to cryptococcosis. A total of 118 serum specimens were tested in triplicate. Percent positive was determined for each condition (Table 3).
| Pathology | # of Samples | % Positive |
|---|---|---|
| Penicilliosis | 5 | 0 % (0/5) |
| Sporothrichosis | 6 | 0 % (0/6) |
| HAMA | 5 | 0 % (0/5) |
| Syphilis | 10 | 0 % (0/10) |
| Rubella | 5 | 0 % (0/5) |
| Mycoplasmosis | 10 | 0 % (0/10) |
Table 3. Analytical Specificity
Rev. 07/18/2011
4
510(k) Premarket Notification CrAg Lateral Flow Assay
Immuno-Mycologics, Inc Norman, OK
| Toxoplasmosis | 7 | 0 % (0/7) |
|---|---|---|
| CMV | 10 | 0 % (0/10) |
| Blastomycosis | 10 | 0 % (0/10) |
| Coccidiomycosis | 10 | 0 % (0/10) |
| Histoplasmosis | 10 | 0 % (0/10) |
| Candidiasis | 10 | 0 % (0/10) |
| Aspergillus GM+ | 10 | 10 % (1/10) |
| Rheumatoid Factor* | 10 | 0 % (0/10) |
- Rheumatoid factor concentrations tested ranged from 112W/ml to 64791U/ml.
Additionally, cross-reactivity was assessed by testing crude culture filtrate antigens at a range of concentrations using the CrAg Lateral Flow Assay. At high concentrations (>0.1 mg/ml), antigens from Paracoccidiodes brasiliensis exhibitied some cross-reactivity. Antigens from Aspergillus terreus, Aspergillus fumigatus, Aspergillus niger, and Aspergillus flavus did not exhibit cross-reactivity.
Interference testing was also performed on five icteric, five hemolyzed, and five lipemic serum specimens. Each specimen was spiked with cryptococcal antigen at three times the C95 concentration. All specimens were then tested at IMMY, on one lot of CrAg Lateral Flow assay in triplicate: spiked and unspiked. Percent positivity was determined for each condition. All of the unspiked specimens had negative results on the CrAg Lateral Flow Assay. All spiked specimens were positive, thus, these types of serum specimens do not interfere with the CrAg Lateral Flow Assay. However, it is possible that hemolyzed samples could lead to false negatives due to the high background color on the strip.
The effect of pronase on the CrAg LFA was determined by pronase-treating 5 Cryptococcal EIA positive specimens and 5 Cryptococcal EIA negative specimens. The samples were analyzed both untreated and pronase-treated. All treated, positives samples remained positive and all treated, negative samples remained negative. Therefore, pronase does not affect the CrAg LFA.
Due to specimen availability, the following conditions were not tested in the CrAg Lateral Flow Assay: Candida dubliniensis, Candida tropicalis, Candida parapsidosis, Candida krusei, Candida glabrata, Cladosporium trichoides, Neisseria meningitidis, Salmonella typhi, Pneumocystis carinii, Trichosporon beigelii, Zygomycetes, ANA+, HAV, HCV, Staph, and Strep.
-
D. Linearity
N/A -
E. High Dose Hook Effect
High dose hook effect concentrations with serum specimens were determined by spiking negative serum that was negative by the IMMY Latex-Cryptococcus Antigen Detection System and CrAg Lateral Flow Assay, with cryptococcal antigen at various concentrations
5
510(k) Premarket Notification CrAg Lateral Flow Assay
between 20 and 500ug/ml. Each concentration was tested in triplicate at IMMY on one lot of CrAg Lateral Flow Assay, according to the package insert. It was determined that serum specimens with a cryptococcal antigen concentration higher than 200ug/ml can produce a high dose hook effect and therefore may produce a false negative result.
- F. Method Comparison
Method Comparison: Cryptococcal Antigen EIA
The CrAg Lateral Flow Assay was compared to a Cryptococcal Antigen EIA, which detects cryptococcal antigens in serum.
A panel of 197 serum specimens that were submitted to a US reference laboratory for cryptococcal antigen testing, using the Cryptococcal Antigen EIA, were collected and stored frozen until method comparison studies were performed. Specimens were then thawed and tested concurrently in the CrAg LFA and in a latex agglutination test [See "Predicate Method Comparison - Latex-Cryptococcal Antigen Detection System (K791382)]. The resulting data is presented in a 2x2 contingency table (Table 4). The percent agreement positive, percent agreement negative, and 95% confidence interval are also presented (Table 5).
Table 4. Serum 2x2 Contingency Table
| EIA (+) | EIA (-) | |
|---|---|---|
| CrAg Lat Flow (+) | 96 | 7 |
| CrAg Lat Flow (-) | 0 | 94 |
Table 5. Serum Statistical Analysis
| 95% CI | ||
|---|---|---|
| % Agreement Positive | 100% | 96-100% |
| % Agreement Negative | 93% | 86-97% |
Other Method Comparison - Culture/India Ink (Gold Standards)
The CrAg Lateral Flow Assay was compared to the gold standard for the diagnosis of cryptococcosis (culture and/or India Ink) to evaluate the sensitivity and specificity of the assay. These studies contained a mix of both prospective and retrospective specimens. A summary of the data collected in included in Tables 6 and 7 below:
Table 6. Serum 2x2 Contingency Table: Culture/India Ink
| | | - Callide France
ure/India Ink | |
|-----------|------------------------------------------------------------------|--------------------------------------------------------------|--|
| | | Carlos of the Charles
. | |
| COLLEGIAL | NO ANDRE & FOR A LE SE SE SE SE SE SE SERVED AN A SE
24.4 | -
A Children Children Children Children Children Children | |
6
| Assay | Negative | 0 |
|---|---|---|
| Table 7. Serum Statistical Analysis: Culture/India Ink | ||
| Calculated | 95% CI | |
| Sensitivity | 100% | 96.0%-100% |
| Specificity | 100% | 97.0%-100% |
Predicat Device Comparison - Latex-Cryptococcal Antigen Detection System (K791382)
Serum Specimens:
A panel of 197 serum specimens that were submitted to a US reference laboratory for cryptococcal antigen testing, using a Cryptococcal Antigen EIA, were collected and stored frozen until method comparison studies were performed. Of the 197 specimens, 96 were positive and 101 were negative by the EIA. All specimens were analyzed, according to EP12-A2, concurrently in the CrAg Lateral Flow Assay and in the IMMY Latex-Cryptococcus Antigen Detection System to ensure the data was not affected by the freeze-thaw cycle. Each specimen was tested at IMMY in duplicate in both tests according to each test's package insert. The data is presented in a 2x2 contingency table (Table 8). The percent agreement positive, percent agreement negative, and 95% confidence interval are also presented (Table 9).
Table 8. Serum 2x2 Contingency Table: Latex Agglutination
| Latex (+) | Latex (-) | |
|---|---|---|
| CrAg LFA (+) | 101 | 2 |
| CrAg LFA (-) | 0 | 94 |
Table 9. Serum Statistical Analysis: Latex Agglutination
| 95% CI | ||
|---|---|---|
| % Agreement Positive | 100% | 96-100% |
| % Agreement Negative | 98% | 93-99% |
Semi-Quantitative Serum
Sixty-two serum specimens that tested positive by the IMMY Latex-Cryptococcus Antigen Detection System during the qualitative method comparison were stored frozen (-80° C) then analyzed in the CrAg Lateral Flow Assay (LFA) to determine the specimens' titers (Semiquantitative analysis). Concurrently, the specimens were tested in the IMMY Latex-Cryptococcus Antigen Detection System (LA) to determine the latex titer for each specimen. The entire panel was tested at IMMY according to each test's package insert. Cryptococcus Antigen Latex titer versus CrAg Lateral Flow Test titer was plotted and regression analysis performed. The data show a strong correlation between the two tests (R2 = 0.905).
Conclusion
Rev. 07/18/2011
7
510(k) Premarket Notification CrAg Lateral Flow Assay
The information submitted in this premarket notification is complete and supports a substantial equivalence decision.
.
.
.
8
Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Immuno-Mycologics, Inc c/o Sean K. Bauman, Ph.D. President and CEO 2700 Technology Place Norman, OK 73071
JUL 2 0 2011
| Re: | K102286 |
|---|---|
| Trade/Device Name: | CrAg Lateral Flow Assay |
| Regulation Number: | 21CFR §866.3165 |
| Regulation Name: | Crptococcus neoformans serological reagents. |
| Regulatory Class: | Class II |
| Product Code: | GMD |
| Dated: | July 18, 2011 |
| Received: | July 19, 2011 |
Dear Dr. Bauman:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section
9
Page 2 - Sean K. Bauman, Ph.D.
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 advice for your device on our labeling regulation (21 CFR Part 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jill, Attyns
Sally A. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
10
510(k) Premarket Notification CrAg Lateral Flow Assay
Indications for Use Statement
510(k) Number (if known):
Device Name: CrAg Lateral Flow Assay
Indications for Use:
The Cryptococcal Antigen Lateral Flow Assay (CrAg LFA) is an immunochromatographic test system for the qualitative or semi-quantitative detection of capsular polysaccharide antigens of Cryptococcus species complex (Cryptococcus neoformans and Cryptococcus gattii) in serum.
The CrAg Lateral Flow Assay is a prescription-use laboratory assay, which can aid in the diagnosis of cryptococcosis.
Prescription Use l (Part 21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use_ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Freddie K. Rode
Division Sign Off
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k): K102286