(263 days)
Not Found
No
The device description and performance studies detail a standard immunoassay process and analysis of optical density readings, with no mention of AI or ML algorithms for data interpretation or decision making.
No
The device is an in vitro diagnostic (IVD) assay designed to detect antigens for an aid in diagnosis, not to provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The ALPHA Cryptococcal Antigen Enzyme Immunoassay is an assay which can be used as an aid in the diagnosis of cryptococcosis."
No
The device description clearly outlines a laboratory-based immunoassay kit involving physical reagents, microwell plates, and a microplate reader for optical density measurement. This is a hardware-dependent diagnostic test, not a software-only device.
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 device is a "test system for the detection of capsular polysaccharide antigens of Cryptococcus species complex... in serum and cerebrospinal fluid (CSF)." It also states it is used "as an aid in the diagnosis of cryptococcosis." This clearly indicates the device is intended for use in vitro (outside the body) to examine specimens (serum and CSF) for diagnostic purposes.
- Device Description: The description details a laboratory-based assay using microwell plates, antibodies, and enzymatic reactions to detect antigens in patient specimens. This is characteristic of an in vitro diagnostic test.
- Performance Studies: The document describes various performance studies (Precision, Analytical Sensitivity, Analytical Specificity, Interference, Method Comparison) conducted on patient specimens (serum and CSF). These studies are standard for evaluating the performance of IVD devices.
- Key Metrics: The document provides key metrics like sensitivity and specificity, which are crucial for assessing the diagnostic accuracy of an IVD.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K904393) is a strong indicator that this device is being submitted for regulatory review as an IVD, often in comparison to a previously cleared IVD.
N/A
Intended Use / Indications for Use
The ALPHA Cryptococcal Antigen enzyme immunoassay (CrAg EIA) is a qualitative or semi-quantitative (titration) test system for the detection of capsular polysaccharide antigens of Cryptococcus species complex (Cryptococcus neoformans and Cryptococcus gattii) in serum and cerebrospinal fluid (CSF). The ALPHA Cryptococcal Antigen Enzyme Immunoassay is an assay which can be used as an aid in the diagnosis of cryptococcosis. Test results are to be used in conjunction with information available from the patient clinical evaluation and other diagnostic procedures.
Product codes
MDU
Device Description
The ALPHA Cryptococcal Antigen Enzyme Immunoassay (EIA) is a direct immunoenzymatic sandwich microplate assay which detects Cryptococcus antigens in serum and CSF. Anti-Cryptococcus antibodies bound to microwell plates are used as capture antibodies, and horseradish peroxidase (HRP)-conjugated anti-Cryptococcus antibodies are used as detect antibodies. The positive control and standard curve material are composed of cryptococcal capsular polysaccharide antigen in a buffered protein solution with a preservative. In the qualitative procedure, specimens are analyzed undiluted. In the titration procedure, specimens are analyzed after serial dilution in specimen diluent. Either serum or CSF is added to the microwells coated with the capture antibodies and incubated. If the patient specimen contains cryptococcal antigens that are recognized by the capture antibodies, those antigens will become bound to the microwells. The microwells are washed to remove unbound patient material, and HRP-conjugated detect antibody is added to the wells. If Cryptococcus antigens are bound to the microwells by the capture antibodies, the detect antibody will also become bound to the microwells. The wells are then washed to remove any unbound detect antibody. Next, tetramethylbenzidine (TMB) substrate is added to the microwells, and in the presence of HRP, a blue color will develop. The reaction is stopped by the addition of a stop solution. The optical density (OD) is determined with a microplate reader at 450 nm with reference at 630 nm (reference is optional).
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
Not Found
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
-
Precision Studies:
- Methods: The ALPHA Cryptococcal Antigen EIA was evaluated for reproducibility and precision by spiking serum and mock CSF with cryptococcal antigen to produce a panel consisting of a negative sample, a high negative (Cs) sample, a low positive sample and a moderate positive sample. This panel was tested twice per day at three sites [Immuno-Mycologics, Inc., a national reference lab, and a clinical lab] with a total of five operators over a five-day period.
- Results: Detailed tables showing Ave O.D., Std Dev, and %CV for various sample types (Blank, CRYPC1, Negative Serum, High Negative Serum, Low Positive Serum, Moderate Positive Serum, Negative CSF, High Negative CSF, Low Positive CSF, Moderate Positive CSF) across three sites and combined data. The reproducibility study also presented percent positive for each specimen type across sites.
- Serum: Negative (0%), High Negative (0%), Low Positive (100%), Moderate Positive (100%).
- CSF: Negative (0%), High Negative (24% overall), Low Positive (100%), Moderate Positive (100%).
-
Analytical Sensitivity (Lower limits of the assay) - LoB and LoD Testing Methods:
- Methods: Analytical sensitivity was estimated at IMMY according to Clinical and Laboratory Standards Institute (CLSI) EP-17A. LoB (limit of blank) was estimated by running 80 replicates of normal human serum and 80 replicates of artificial CSF. Initial LoD (limit of detection) was estimated by running 20 replicates of 4 concentrations near the LoB in both serum and CSF. LoD was established by testing 24 replicates of both serum and CSF spiked with Cryptococcal antigen at a range of concentrations near the initial LoD. Results were considered positive if they yielded a blanked OD that was greater than the cut-off.
- Results: For serum the LoD was 5.3 ng/ml. For CSF, the LoD was 1.7 ng/ml.
-
Analytical Specificity (Cross-Reactivity):
- Methods: Determined by running potentially cross-reacting medical conditions unrelated to cryptococcosis. 118 serum specimens and 15 fungal culture filtrates were tested. Culture filtrates were tested at three dilutions: undiluted, 1:10, and 1:100.
- Results: One Aspergillus galactomannan positive specimen was positive. Paracoccidioides brasiliensis culture filtrates undiluted and 1:10 were positive. Total percent positive for fungal pathologies was 3.9%. Paracoccidioides brasiliensis Culture Filtrate had a total percent positive of 67%. Rheumatoid factor (112 IU/ml and 6479 IU/ml) did not cause false positives.
-
Interference Studies:
- Methods: Tested 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 tested at IMMY, on one lot of the ALPHA Cryptococcal Antigen EIA in triplicate: spiked and unspiked.
- Results: All unspiked specimens had negative results. All spiked specimens were positive.
-
High Dose Hook Effect:
- Methods: A serum specimen pool negative by IMMY Latex-Cryptococcus Antigen Detection System and ALPHA Cryptococcal Antigen EIA was spiked with cryptococcal antigen at 1 mg/ml and tested in triplicate.
- Results: At extremely high concentrations, the signal can be reduced due to the high dose hook effect, but the result is still positive. The semi-quantitative titration procedure can differentiate a low EIA score due to high dose hook effect from one due to low antigen concentrations.
-
Specimen Acceptance Criteria - Freeze-Thaw Study:
- Methods: Three CrAg-Negative human CSF specimens and four CrAg-Negative human serum specimens were spiked with Cryptococcal Antigen near and slightly above the cutoff. Specimens were tested immediately, then frozen at
§ 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.
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K1209Y6
Immuno-Mycologics, Inc. Norman, OK
510(k) Premarket Notification ALPHA Cryptococcal Antigen EIA
510(k) Summary ALPHA Cryptococcal Antigen EIA
This 510(k) summary is submitted in accordance with 21 CFR §807.92
DEC 1 7 2012
- 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
February 27th, 2012 Prepared:
ALPHA Cryptococcal Antigen EIA Trade Name:
- Common Name: Cryptococcus Antigen EIA
Classification Name: Antigen, Elisa, Cryptococcus
Regulation: 866.3165
Predicate Device: Meridian's Premier™ Cryptococcal Antigen EIA, K904393
The ALPHA Cryptococcal Antigen enzyme immunoassay (CrAg EIA) is a Intended Use: qualitative or semi-quantitative (titration) test system for the detection of capsular polysaccharide antigens of Cryptococcus species complex (Cryptococcus neoformans and Cryptococcus gattii) in serum and cerebrospinal fluid (CSF). The ALPHA Cryptococcal Antigen Enzyme Immunoassay is an assay which can be used as an aid in the diagnosis of cryptococcosis. Test results are to be used in conjunction with information available from the patient clinical evaluation and other diagnostic procedures.
Device Description:
The ALPHA Cryptococcal Antigen Enzyme Immunoassay (EIA) is a direct immunoenzymatic sandwich microplate assay which detects Cryptococcus antigens in serum and CSF. Anti-Cryptococcus antibodies bound to microwell plates are used as capture antibodies, and horseradish peroxidase (HRP)-conjugated anti-Cryptococcus antibodies are used as detect antibodies. The positive control and standard curve material are composed of cryptococcal capsular polysaccharide antigen in a buffered protein solution with a preservative. In the qualitative procedure, specimens are analyzed undiluted. In the titration procedure, specimens are analyzed after serial dilution in specimen diluent. Either serum or CSF is added to the microwells coated with the capture antibodies and incubated. If the patient specimen contains cryptococcal antigens that are recognized by the capture antibodies, those antigens will
1
Immuno-Mycologics, Inc. Norman, OK
become bound to the microwells. The microwells are washed to remove unbound patient material, and HRP-conjugated detect antibody is added to the wells. If Cryptococcus antigens are bound to the microwells by the capture antibodies, the detect antibody will also become bound to the microwells. The wells are then washed to remove any unbound detect antibody. Next, tetramethylbenzidine (TMB) substrate is added to the microwells, and in the presence of HRP, a blue color will develop. The reaction is stopped by the addition of a stop solution. The optical density (OD) is determined with a microplate reader at 450 nm with reference at 630 nm (reference is optional).
Comparison with Predicate:
A comparison of the similarities and differences between the ALPHA Cryptococcal Antigen EIA and the predicate device is presented in the tables below (Table 1).
| Assay
Feature | SIMILARITIES
ALPHA Cryptococcal Antigen EIA
New Device | Premier Cryptococcal Antigen EIA
K904393 |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | | |
| Intended Use | Detection of capsular polysaccharide antigens | Detection of capsular polysaccharide antigens |
| Indication For Use | Aid in the diagnosis of cryptococcosis | Aid in the diagnosis of cryptococcosis |
| Device Description | | |
| Assay Principle | EIA | EIA |
| Sample Matrix | Serum & CSF | Serum & CSF |
| Assay components | Antibody coated 96-well microplate, wash buffer,
positive control, enzyme conjugate, TMB substrate,
stop solution, sample diluent | Antibody coated 96-well microplate, wash buffer,
positive control, enzyme conjugate, TMB substrate,
stop solution, sample diluent |
| Detection Chemistry | HRP + TMB | HRP + TMB |
| Specimen pre-treatment? | none | none |
| Controls/Standard | Cryptococcal Antigen | Cryptococcal Antigen |
| Microplate | 96-well microplate coated with antigen | 96-well microplate coated with antigen |
Table 1. Similarities and Differences between ALPHA Cryptococcal Antigen EIA and Premier Cryptococcal Antigen EIA
| Assay
Feature | DIFFERENCES
ALPHA Cryptococcal Antigen EIA
New Device | Premier Cryptococcal Antigen EIA
K904393 |
|----------------------|-------------------------------------------------------------|---------------------------------------------|
| Device Description | | |
| Output | Positive or Negative Only | Positive, Negative, and Indeterminate |
| Reagent Application | Pipette or equivalent | Reagent Droppers |
| Optional Visual Read | No | Yes |
Analytical Performance Summary
- A. Precision Studies
Precision Test Methods:
2
The ALPHA Cryptococcal Antigen ElA was evaluated for reproducibility and precision by spiking serum and mock CSF with cryptococcal antigen to produce a panel consisting of a negative sample, a high negative (Cs) sample, a low positive sample and a moderate positive sample. This panel was tested twice per day at three sites [Immuno-Mycologics, Inc., a national reference lab, and a clinical lab] with a total of five operators over a five-day period in order to determine both the inter-lab and the intra-lab reproducibility and precision of the assay. The results of this study are shown in the table below.
| IMMY | National Reference Lab | Clinical Lab | Combined Data (3 Sites) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Description | Type | Ave | |||||||||||
| O.D. | Std | ||||||||||||
| Dev | %CV | Ave | |||||||||||
| O.D. | Std | ||||||||||||
| Dev | %CV | Ave | |||||||||||
| O.D. | Std | ||||||||||||
| Dev | %CV | ਕਿਪਦ | |||||||||||
| 0.0. | Std. | ||||||||||||
| Dev. | %CV | ||||||||||||
| Blank | Control | 0.066 | 0.012 | 17.8 | 0.000 | 0.0027 | 3585.2 | 0.075 | 0.005 | 7.0 | 0.046 | 0.034 | 74.67 |
| CRYPC1 | Control | 1.814 | 0.078 | 4.3 | 1.973 | 0.1083 | ર્ટ રે | 2.473 | 0.158 | 6.4 | 2.059 | 0.295 | 14.34 |
| Negative | Serum | 0.022 | 0.011 | 48.7 | 0.012 | 0.0058 | 48.8 | 0.019 | 0.005 | 25.4 | 0.018 | 0.009 | 50.25 |
| High Negative | Serum | 0.040 | 0.008 | 19.2 | 0.028 | 0.0077 | 27.7 | 0.035 | 0.007 | 20.0 | 0.034 | 0.009 | 26.51 |
| Low Positive | Serum | 0.420 | 0.041 | 9.7 | Q.338 | 0.0436 | 12.9 | 0.372 | 0.038 | 10.3 | 0.377 | 0.053 | 14.16 |
| Moderate Positive | Serum | 1.683 | 0.229 | 13.6 | 1.666 | 0.1281 | 7.7 | 1.959 | 0.205 | 10.5 | 1.756 | 0.229 | 13.05 |
| Negative | CSF | 0.065 | 0.018 | 27.8 | 0.028 | 0.0087 | 15.1 | 0.099 | 0.010 | 10.0 | 0.072 | 0.022 | 29.85 |
| High Negative | CSF | 0.179 | 0.020 | 11.1 | 0.174 | 0.0190 | 10.9 | 0.298 | 0.027 | 9.2 | 0.211 | 0.059 | 28.09 |
| Low Positive | CSF | 0.346 | 0.028 | 8.0 | 0.339 | 0.0319 | ਰੇ ਕੇ | 0.533 | 0.039 | 7.3 | 0.397 | 0.092 | 23.27 |
| Moderate Positive | CRF | 0.629 | 0.039 | 6.2 | 0.606 | 0.0443 | 7.3 | 0.929 | 0.056 | 6.0 | 0.707 | 0.149 | 21.13 |
Below is the data from the reproducibility study presented by percent positive for each specimen type.
| Serum | Site 1 % | Site 2 % | Site 3 % | Overall % |
|---|---|---|---|---|
| Positive | Positive | Positive | Positive | |
| Negative | 0% | 0% | 0% | 0% |
| High Negative | 0% | 0% | 0% | 0% |
| Low Positive | 100% | 100% | 100% | 100% |
| Moderate Positive | 100% | 100% | 100% | 100% |
| CSF | Site 1 % | |||
| Positive | Site 2 % | |||
| Positive | Site 3 % | |||
| Positive | Overall % | |||
| Positive | ||||
| Negative | 0% | 0% | 0% | 0% |
| High Negative | 0% | 0% | 83% | 24% |
| Low Positive | 100% | 100% | 100% | 100% |
| Moderate Positive | 100% | 100% | 100% | 100% |
- B. Analytical Sensitivity (Lower limits of the assay)
LoB and LoD Testing Methods
Analytical sensitivity was estimated at IMMY according to Clinical and Laboratory Standards Institute (CLSI) EP-17A. The limit of the blank (LoB) was estimated by running 80 replicates of normal human serum and 80 replicates of artificial CSF. The initial limit of detection (LoD) was estimated by running 20 replicates of 4 concentrations near the LoB in both serum and CSF.
The LoD was established by testing 24 replicates of both serum and CSF spiked with Cryptococcal antigen at a range of concentrations near the initial LoD. Results were considered positive if they yielded a blanked OD that was greater than the cut-off.
Analysis shows that for serum the LoD was 5.3 ng/ml. For CSF, the LoD was 1.7 ng/ml.
3
C. Analytical Specificity (Cross-Reactivity)
Analytical specificity for the ALPHA Cryptococcal Antigen EIA was determined by running potentially cross-reacting medical conditions unrelated to cryptococcosis. The following specimens were run on one lot of the ALPHA Cryptococcal Antigen EIA. A total of 118 serum specimen and 15 fungal culture filtrates were tested. Culture filtrates were tested at three different dilutions: undiluted, 1:10, and 1:100. Dilutes were made in 1X Specimen Diluent. Percent positive was determined for each condition.
As expected, some fungal cross-reactivity was observed. One Aspergillus galactomannan positive specimen (positive by Bio-Rad's Platelia™ Aspergillus EIA) was positive in the ALPHA Cryptococcal Antigen EIA and Paracoccidioides brasiliensis culture filtrates undiluted and 1:10 were positive as well. The total percent positive for fungal pathologies was 3.9%, well below the acceptance criteria of 10%. However, Paracoccidioides brasiliensis Culture Filtrate had a total percent positive of 67%.
Rheumatoid factor is known to cause false-positive results in the Cryptococcal latex agglutination method. Rheumatoid factor did not cause false positives in the ALPHA Cryptococcal Antigen EIA between the range of 112 IU/ml and 6479 IU/ml. The normal reference range for rheumatoid factor is 0-14 IU/ml.
D. Interference Studies
In addition to the cross-reactivity study, 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 the ALPHA Cryptococcal Antigen EIA in triplicate: spiked and unspiked.
All of the unspiked specimens had negative results on the ALPHA Cryptococcal Antigen EIA. All spiked specimens were positive, thus, these types of serum specimens do not interfere with the ALPHA Cryptococcal Antigen EIA.
- E. High Dose Hook Effect
The effects of high doses were determined by spiking a serum specimen pool that was negative by the IMMY Latex-Cryptococcus Antigen Detection System and ALPHA Cryptococcal Antigen EIA, with cryptococcal antigen at 1 mg/ml and testing it in triplicate at IMMY on one lot of ALPHA Cryptococcal Antigen EIA, according to the package insert.
It was observed that at extremely high concentrations, the signal can be reduced due to the high dose hook effect. Although the signal is reduced leading to lower than expected EIA values, the result is still positive. The semi-quantitative titration procedure can differentiate between a low EIA score due to the high dose hook effect and a low EIA score due to low concentrations of Cryptococcal Antigen.
4
F. Specimen Acceptance Criteria - Freeze-Thaw Study
Three CrAg-Negative human CSF specimens and four CrAg-Negative human serum specimens were spiked with concentrations of Cryptococcal Antigen near and slightly above the cutoff of the assay. The specimens were tested on the ALPHA CrAg EIA immediately after spiking and then they were frozen at 0.265$ | Positive |
F. Method Comparison
Comparison to Another Manufacturer's Device
A three-site (IMMY and two national reference laboratories) split-specimen comparison study was performed on both serum and CSF specimens that had been submitted for cryptococcal antigen ElA testing. A total of 1782 specimens (CSF n=426; serum n=1356) were tested in both the ALPHA Cryptococcal Antigen EIA and a commercial Cryptococcal antigen EIA according to their respective package inserts.
The resulting data from the split sample comparison is shown in the tables below.
Serum 2x2 Contingency Table
| Commercial EIA (+) | Commercial EIA (-) | |
|---|---|---|
| IMMY EIA (+) | 131 | 28 |
| IMMY EIA (-) | 2 | 1195 |
CSF 2x2 Contingency Table
| Commercial EIA (+) | Commercial EIA (-) | |
|---|---|---|
| IMMY EIA (+) | 29 | 3 |
| IMMY EIA (-) | 2 | 392 |
The combined results, excluding indeterminates, were analyzed for percent agreement positive, percent agreement negative and overall percent according to Clinical and Laboratory Standards Institute (CLSI) EP12-A2. The results of this analysis are shown in the table below.
| Dataset | Point Estimate | 95% Confidence Interval | |
|---|---|---|---|
| % Agreement Positive | Serum Only | 98.5% | 94.7% - 99.6% |
6
| % Agreement Negative | Serum Only | 97.7% | 96.7% - 98.4% |
|---|---|---|---|
| % Agreement Positive | CSF Only | 93.5% | 79.3% - 98.2% |
| % Agreement Negative | CSF Only | 99.2% | 97.8% - 99.7% |
Comparison to IMMY CrAg Lateral Flow Assay
A three-site (IMMY and two national reference laboratories) split-specimen comparison study was performed on both serum and CSF specimens that had been submitted for cryptococcal antigen EIA testing. A total of 1782 specimens (CSF n=426; serum n=1356) were tested in both the ALPHA Cryptococcal Antigen EIA and the IMMY Cryptococcal Antigen Lateral Flow Assay (LFA) according to their respective package inserts.
The ALPHA Cryptococcal Antigen EIA performs similarly to the IMMY Cryptococcal Antigen Lateral Flow Assay (LFA) with 96.9% and 93.8% Agreement Positive, and 99.8% and 99.5% Agreement Negative to the LFA in serum and CSF, respectively.
Conclusion
The information submitted in this premarket notification is complete and supports a substantial equivalence decision.
7
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Immuno-Mycologics, Inc. c/o Sean K. Bauman, Ph.D. 2700 Technology Place Norman, OK 73071
DEC 1 7 2012
Re: K120946
Trade/Device Name: ALPHA Cryptococcal Antigen EIA Regulation Number: 21 CFR $866.3165 Regulation Name: Cryptococcus neoformans serological reagents Regulatory Class: Class II Product Code: MDU Dated: October 25, 2012 Received: October 26, 2012
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 either class II (Special Controls) or class III (PMA), it may be subject to 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
8
Page 2 - Sean K. Bauman
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form and quinn control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health 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 Tou may 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,
Uwe Scherf for
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics And Radiological Health Center for Devices and Radiological Health
Enclosure
9
Immuno-Mycologics, Inc. Norman, OK
Indications for Use Statement
510(k) Number (if known): K120946
Device Name: ALPHA Cryptococcal Antigen Enzyme Immunoassay
Indications for Use: The ALPHA Cryptococcal Antigen enzyme immunoassay (CrAg EIA) is a qualitative or semi-quantitative (titration) test system for the detection of capsular polysaccharide antigens of Cryptococcus species complex (Cryptococcus neoformans and Cryptococcus gattii) in serum and cerebrospinal fluid (CSF). The ALPHA Cryptococcal Antigen Enzyme Immunoassay is an assay which can be used as an aid in the diagnosis of cryptococcosis. Test results are to be used in conjunction with information available from the patient clinical evaluation and other diagnostic procedures.
Prescription Use ਮ (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) | |
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ence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Concul
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
C
510(k) k 120 946