(255 days)
Trinity Biotech Uni-Gold™ Cryptosporidium is a single use rapid immunoassay for the qualitative detection of Cryptosporidium parvum (C. parvum) antigens in human stool specimens. This test is intended for use with patients with gastrointestinal symptoms as an aid in the diagnosis of suspected Cryptosporidium gastrointestinal infections. As with other Cryptosporidium tests, results should be considered in conjunction with the clinical evaluation and medical history. For In-Vitro Diagnostic use.
The Trinity Biotech Uni-Gold™ Cryptosporidium Test was designed as a single use, rapid, lateral flow immunoassay to detect the presence of Cryptosporidium parvum antigen in unpreserved (fresh & frozen), preserved, and media containing human stool specimens. The Trinity Biotech Uni-Gold™ Cryptosporidium test strip (5mm x 60mm) combines a nitrocellulose membrane with designated fiber pads (conjugate, sample and absorbant). The test strip is then placed into a plastic housing and is sealed constituting the Test Device.
Here's an analysis of the acceptance criteria and study details for the Uni-Gold™ Cryptosporidium device, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly state pre-defined "acceptance criteria" in terms of numerical thresholds for sensitivity and specificity. Instead, it presents the results of studies and aims to demonstrate substantial equivalence to a predicate device. For the purpose of this request, I will infer the implicit acceptance is achieving high sensitivity and specificity in comparison to gold standard methods and predicate devices.
| Metric / Study | Acceptance Criteria (Implicit) | Reported Device Performance (Uni-Gold™ Cryptosporidium) |
|---|---|---|
| Sensitivity (vs. DFA Microscopy) | High agreement with DFA microscopy | 100% (77/77) 95% CI 94 - 100% |
| Specificity (vs. DFA Microscopy) | High agreement with DFA microscopy | 100% (157/157) 95% Cl 97 - 100% |
| PPA (vs. Modified Acid-Fast Stain) | High positive percent agreement | 100% (26/26) |
| NPA (vs. Modified Acid-Fast Stain) | High negative percent agreement | 100% (21/21) |
| PPA (vs. Modified Kinyoun Stain) | High positive percent agreement | 92% (55/60) |
| NPA (vs. Modified Kinyoun Stain) | High negative percent agreement | 90% (198/221) |
| Specificity (Prospective Study vs. DFA Microscopy) | High specificity (as no positives were found) | 100% (378/378) 95% Cl 99 - 100% |
| Inter-run Precision/Reproducibility | 100% reproducibility across sites and days | 100% reproducibility observed for all sites, for all days |
| Cross-Reactivity | No cross-reactivity with common interfering organisms/substances | No cross-reactivity observed with listed organisms; No test interference observed by listed compounds |
2. Sample Size Used for the Test Set and Data Provenance
- Comparator Device Study (Side-by-side with Remel Xpect®): 299 retrospective samples. Data provenance: United States (multiple external sites). Sample matrices included unpreserved frozen, Cary Blair, SAF, and formalin.
- Sensitivity/Specificity Study (vs. DFA Microscopy): 234 retrospective samples (77 positive, 157 negative). Data provenance: United States (2 external laboratories). Sample matrices included formalin, SAF, unpreserved frozen, Cary Blair, and C&S.
- Additional Retrospective Studies (vs. Non-fluorescent Microscopy):
- Site 2: 47 retrospective samples (26 positive, 21 negative) vs. Modified Acid-Fast Stain.
- Site 3: 281 retrospective SAF samples (60 positive, 221 negative) vs. Modified Kinyoun Stain.
- Prospective Study (vs. DFA Microscopy): 378 samples (all negative). Data provenance: one external laboratory in the US. Sample matrices included unpreserved fresh, unpreserved frozen, formalin, SAF, C&S, and Cary Blair.
- Overall Combined Test Set: 940 (prospective and retrospective) samples. Data provenance: Collected from Hospitals throughout the US and Canada.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of individual experts or their exact qualifications (e.g., number of years of experience, specific medical specialty) used to establish the ground truth for the test sets.
Instead, it refers to "DFA microscopy," "Modified Kinyoun Stain light microscopy," and "Modified Acid-Fast Stain" as the reference methods (ground truth). It is implied that these microscopy methods are performed and interpreted by trained laboratory professionals, but specific expert details are not provided.
4. Adjudication Method for the Test Set
The document does not describe an explicit adjudication method (e.g., 2+1 reader consensus) for resolving discrepancies in the reference methods (DFA microscopy, Modified Kinyoun Stain, Modified Acid-Fast Stain).
In cases of discrepancy between the Uni-Gold™ device and the comparator/reference method within the studies, some retesting or re-evaluation against a "higher" ground truth was performed:
- Site 3 (Comparator Device Study): For the 51 samples positive by Uni-Gold™ but negative by comparator, 30 were positive by Modified Kinyoun Stain light microscopy and 3 by DFA microscopy (agreeing with Uni-Gold™). The one sample negative by Uni-Gold™ and positive by comparator was negative by Modified Kinyoun Stain microscopy (agreeing with Uni-Gold™). This indicates that microscopy was used as an adjudicator for samples where the test device and the comparator device disagreed.
- Site 3 (Non-fluorescent Microscopy Study): For the 23 negative samples (by Modified Kinyoun Stain) that tested positive on Uni-Gold™, three subsequently tested positive by DFA microscopy (agreeing with Uni-Gold™). This implies DFA microscopy acted as a higher-level adjudicator for certain discrepancies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This question is not applicable to the Uni-Gold™ Cryptosporidium device. The device is a rapid in vitro diagnostic immunoassay, not an AI-assisted diagnostic tool that involves human readers interpreting images. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed and is not relevant to this type of device.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is also not applicable. The Uni-Gold™ Cryptosporidium device is a standalone lateral flow immunoassay. Its performance is the "algorithm only" performance (the chemical reaction and visual readout) without human intervention in the detection process itself, beyond the initial sample preparation and result interpretation. There is no separate "algorithm without human-in-the-loop" performance as it is the test.
7. The Type of Ground Truth Used
The primary types of ground truth used for the test sets were:
- DFA Microscopy: Direct Fluorescent Antibody microscopy, considered a gold standard for Cryptosporidium detection.
- Modified Kinyoun Stain Light Microscopy: A non-fluorescent microscopy staining method.
- Modified Acid-Fast Stain: Another non-fluorescent microscopy staining method.
- Comparator Device Results: In some comparative studies, the results of the legally marketed predicate device (Remel Xpect® Cryptosporidium) were used for comparison. However, when discrepancies arose in these studies, microscopy methods (DFA or Modified Kinyoun) were often used to adjudicate.
- Clinical Evaluation and Medical History: The intended use statement notes that "results should be considered in conjunction with the clinical evaluation and medical history," implying that clinical context is part of the broader diagnostic process, but the technical ground truth for device performance was microscopy.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of device development or any machine learning algorithm. This device is a biochemical immunoassay, not an AI or machine learning model that requires a discrete training set. The development of the assay's reagents and parameters would have involved internal validation and optimization, but not in the sense of a machine learning training set.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set" for an AI/ML algorithm in this context, this question is not applicable. The ground truth for developing and optimizing the immunoassay would have been established through standard laboratory practices using known positive and negative controls, and possibly characterized clinical samples, during the assay development process, prior to the formal validation studies presented here.
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જન્
510(k) Summary – Uni-Gold™ Cryptosporidium
FEB 8 2013
| 510(k)NumberAssigned: | K121565 |
|---|---|
| Introduction: | Trinity Biotech hereby submits this 510(k) summary for the Uni-GoldTMCryptosporidium Rapid Lateral Flow Test Kit in accordance with therequirements of 21 CFR 807.92(C). |
| Submitter'sIdentification:Name &Address: | MarDx Diagnostics,A Trinity Biotech Company,5919 Farnsworth Ct.Carlsbad, CA. 92008, USA. |
| Contact: | Email:Phone: | Contact Person: Bonnie DeJoy, Corporate VP of RA (Official Correspondent)Bonnie. DeJoy@TrinityUSA. Com716-483-3851 Extension 1030 |
|---|---|---|
| Fax: | 716-488-1990 |
| DateSummaryPrepared: | February 4, 2013 | ||
|---|---|---|---|
| Device TradeName: | Uni-Gold™ Cryptosporidium | ||
| ClassificationName: | Entamoeba histolytica serological reagents.Cryptosporidium SPP 866.3220 Code MHJ | ||
| ClassificationProductCode: | MHJ | ||
| Intended Use: | Trinity Biotech Uni-Gold™ Cryptosporidium is a single use rapid immunoassayfor the qualitative detection of Cryptosporidium parvum (C. parvum) antigens inhuman stool specimens. This test is intended for use with patients withgastrointestinal symptoms as an aid in the diagnosis of suspectedCryptosporidium gastrointestinal infections. As with other Cryptosporidiumtests, results should be considered in conjunction with the clinical evaluationand medical history. For In-Vitro Diagnostic use. |
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| PredicateDevice | Remel Xpect® Cryptosporidium (510K #: K031965) | ||||
|---|---|---|---|---|---|
| DeviceDescription | The Trinity Biotech Uni-Gold™ Cryptosporidium Test was designed as a singleuse, rapid, lateral flow immunoassay to detect the presence of Cryptosporidiumparvum antigen in unpreserved (fresh & frozen), preserved, and mediacontaining human stool specimens. | ||||
| The Trinity Biotech Uni-Gold™ Cryptosporidium test strip (5mm x 60mm)combines a nitrocellulose membrane with designated fiber pads (conjugate,sample and absorbant). The test strip is then placed into a plastic housing andis sealed constituting the Test Device. (Picture A) | |||||
| Picture A- Cryptosporidium Test Strip - 5 mm x 60 mm | |||||
| Sample PadConjugate PadBackingAbsorbent PadNitrocellulosePlastic Housing device | |||||
| The Cryptosporidium nitrocellulose membrane test strip (above) consists of: | |||||
| A)Mouse anti-Cryptosporidium parvum is coated onto the test line region of thetest strip. | |||||
| B)Goat anti-mouse IgG is coated onto the control line region of the test strip. | |||||
| Mouse anti-Cryptosporidium parvum antibodies and Mouse IgG antibodiesC)are conjugated to red latex particles and dried onto inert glass fiber(Conjugate pad), which is inserted into the test strip below the nitrocellulosezone. | |||||
| When Cryptosporidium antigens are present in the sample they combine with |
the antibody/red latex. As this complex migrates it binds to the antibodies in the test region forming a visible pink/red band. Excess conjugate forms a second
.
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pink/red band in the control region of the device. The control line should always appear as a visible pink/red band in the control region of the device. The internal control line is to ensure and indicate that the test device is functioning correctly. This forms the basis for the double antibody sandwich assay. (Picture B) Picture B- Cryptosporidium Test Device
The test concept:
Mouse anti-Cryptosporidium parvum is coated onto the test line region of the nitrocellulose zone of the test strip. Goat anti-Mouse IgG is coated onto the control line region. Mouse anti-Cryptosporidium parvum and Mouse IgG antibodies are conjugated to red latex particles and dried onto inert glass fiber. This is inserted into the test strip below the nitrocellulose zone.
A buffered solution is added to a dilution tube followed by the addition of the stool specimen (2 drops) via a disposable pipette. This mixture is then dispensed in total into the sample well of the lateral flow cartridge device with a dropper pipette and migrates through a pad containing red microspheres that have been coated with a antibody specific for the Cryptosporidium antigen. If the antigen is present, an immune complex forms. The migration continues along the membrane, which contains a striped down anti Cryptosporidium capture antibody. If Cryptosporidium antigen is present, the immune complex reacts with the anti- Cryptosporidium antibody at the test line on the membrane. Thus Cryptosporidium antigens present in the sample combine with the antibody/red
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latex. As this complex migrates it binds to the antibodies in the test region forming a visible pink/red band.
Excess conjugate forms a second pink/red band in the control region of the device. The control line should always appear as a visible pink/red band in the control region of the device to indicate that the test device is functioning correctly.
Comparison The predicate device and the Uni-Gold™ Cryptosporidium use similar lateral flow with technology and concepts. The following table provides a comparative summary Predicate for both device design features. Any differences in technology do not raise Device: additional concerns regarding safety and effectiveness. Safety and effectiveness are demonstrated to be substantially equivalent.
| Aspect or Feature | Remel-K031965Xpect® Cryptosporidium | Trinity BiotechUni-Gold ™ Cryptosporidium | |
|---|---|---|---|
| Comparison Table | |||
| Intended Use | Detection ofCryptosporidium specificantigen in fecal specimens. | Detection of Cryptosporidiumantigens in stool (fecal)specimens. | |
| Technology | Qualitative immunechromatographic assay | Qualitative immunechromatographic assay | |
| Captureantibodies onmembrane | Rabbit anti-Cryptosporidium, goat anti-mouse IgG | Mouse anti-Cryptosporidiumparvum, goat anti-mouse IgG | |
| Material:Membrane | Mylar-backedNitrocellulose | Nitrocellulose | |
| Conjugateantibodies | Monoclonal anti-cryptosporidium | Mouse anti-Cryptosporidiumparvum, mouse IgG | |
| Material:Conjugate | Anti-mouse and anti-Cryptosporidium coloredmicroparticles diluted inbuffer | Anti-Cryptosporidium andMouse IgG colored latex driedonto conjugate pad | |
| SpecimenTypes | Human Stool preserved in10% formalin, SAF, or CaryBlair | Human Stool: fresh/frozen orpreserved in 10% formalin,SAF or Cary Blair, or C&STransport Medium | |
| Samplevolume | 100 μl | 2 drops- approximately 40-60μl |
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Precision / Reproducibility An Intra-run precision/reproducibility study was performed at 3 sites including one internal site. This study consisted of 12 blind proficiency panel members, varying in reactivity: (4) Low Positive, (4) High Positive and (4) Negative samples. This panel was tested for a period of 5 days. Each site generated 2 runs per day, by two individual technicians totaling 20 replicates per site per panel member, i.e.60 replicates total for each panel member in entire 3 site study. 100% reproducibility was observed for all sites, for all days using the blind panel sample set, therefore 100% of the samples tested for Cryptosporidium produced the expected result.
The Trinity Biotech Uni-Gold™ Cryptosporidium (1206620) along with Uni-Gold™ Cryptosporidium Control kit (1206621) was evaluated at 3 external laboratories. A total of 299 retrospective samples were tested side by side on the test device and a commercially available lateral flow test at three external sites in the following stool matrix types: unpreserved frozen (37), Cary Blair (4), SAF (159), and formalin (99). The percent agreement of Uni-Gold™ Cryptosporidium versus the comparator device was as follows:
| Site 1 | Cryptosporidium | Comparator Device | % Agr | |
|---|---|---|---|---|
| + | - | |||
| Uni-Gold™ | + | 24 | 1 | 100% Pos Agr |
| - | 0 | 52 | 98.1% Neg Agr |
| Site 2 | Cryptosporidium | Comparator Device | % Agr | |
|---|---|---|---|---|
| + | - | |||
| Uni-Gold™ | + | 56 | 1 | 100% Pos Agr |
| Uni-Gold™ | - | 0 | 55 | 100% Neg Agr |
| Site 3 | Cryptosporidium | Comparator Device | % Agr | |
| + | - | |||
| Uni-Gold™ | + | 27 | 51* | 96.4% Pos Agr |
| - | 1** | 32 | 38.6% Neg Agr |
Percent Correlation
*At Site 3, out of 51 samples that tested positive on Uni-Gold™ Cryptosporidium and negative on the comparator device, 30 samples were positive by Modified Kinyoun Stain light microscopy and three samples were positive for Cryptosporidium by DFA microscopy in agreement with the Uni-Gold™ Cryptosporidium result.
Uni-Gold™ **The one sample that tested negative on Cryptosporidium and positive on the comparator device was negative by Modified Kinyoun Stain microscopy in agreement with the Uni-Gold™ Cryptosporidium result.
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Trinity Biotech
YOUR DIAGNOSTICS PARTNER
Cross Reactivity
No cross reactivity was observed using samples containing the following organisms: Adenovirus serotypes 3, 5, 7, 40, 41, Aeromonas hydrophila, Ascaris Iumbricoides, Bacteroides fragilis, Bacillus cereus, Bacillus subtilis, Blastocystis hominis, Campylobacter coli, Campylobacter fetus, Campylobacter jejuni, Candida albicans, Chilomastix mesnili, Clostridium difficile, Clostridium biffermentans, Coronavirus OC43, Coxsackievirus, Cyclspora cavetanensis, Cytomegalovirus (CMV), Dientamoeba fragilis, Diphyllobothrium latum, Echovirus 20, Endolimax nana, Entamoeba coli, Entamoeba hartmanni, Entamoeba histolytica, Enterobius vermincularis, Enterococcus faecalis, Escherichia coli, Escherichia coli 0157H7, Giardia lamblia, Hookworm, Hymenolepis nana, lodamoeba butschlii, Isospora sp., Klebsiella pneumoniae, Microsporidia, Salmonella typhimurium, Shigella dysenteriae, Shigella flexneri, Shigella sonnei, Staphylococcus aureua, Staphylococcus aureus (Cowan's), Staphylococcus epidermidis, Strongyloides stercoralis, Taenia sp., Trichurius trichiura, Vibrio parahaemolyticus, and Yersinia enterocolitica.
Cross Reactivity has not been established for E. dispar.
The analytical specificity of the test was determined in stool samples containing potentially interfering substances at clinically relevant concentrations. Compounds were respectively spiked into positive and negative samples at medically relevant dosages (treatment). All treatments, including the unspiked (neat) positive and unspiked (neat) negative samples were tested in duplicate with Uni-Gold™ Cryptosporidium. The following compounds were tested: Human blood (20% v/v), Mucin (3.5% w/v), Stool fat (Triglycerides 0.14mg/ml or Stearic Acid 20% v/v), Pepto-Bismol (Bismuth) (20% v/v), Imodium A-D (Loperamide HCl) (20% v/v), Kaopectate (Attapugite) (20% v/v), Vancomycin (0.6mg/ml), K-Y jelly Vasoline (0.22mg/ml), (0.289mg/ml), Condom lubricant (1.716mg/ml), Maalox (magnesium hydroxide, calcium carbonate) (20% v/v), Tagamet (Cimetidine) (2.0x10" mg/ml), Pepsid
(Famotidine) (6.0x10 mg/ml), Zantac (Ranitidine) (6.0x103 mg/ml), Prilosec (Omeprazole) (6.0x103 mg/ml), Nitrazoxanide (6.96x10" mg/ml), Atovaquone (0.031mg/ml), Azithromycin (1.2x10-2 mg/ml), (0.12mg/ml), Metronidazole Paromomycin (0.42mg/ml), Trimethoprim-sulfamethoxazole (TRM 0.04mg/ml & Sulf 0.4mg/ml). No test interference was observed by any of the compounds at the concentrations tested.
Sensitivity / Specificity
.
Interfering Substance
The Trinity Biotech Uni-Gold™ Cryptosporidium (1206620) along with Uni-Gold™ Cryptosporidium Control kit (1206621) was evaluated at 4 external laboratories. The sensitivity and specificity of the test was compared against DFA microscopy with retrospective samples at sites 1 and 2 as shown in the following table.
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| Cryptosporidium | DFA Microscopy | |||
|---|---|---|---|---|
| + | - | |||
| Site 1 | Uni-Gold™ | + | 28 | 0 |
| - | 0 | 103 | ||
| Site 2 | Uni-Gold™ | + | 49 | 0 |
| - | 0 | 54 | ||
| Total | Uni-Gold™ | + | 77 | 0 |
| - | 0 | 157 |
Sensitivity: 100% (77/77) 95% CI 94 - 100% Specificity: 100% (157/157) 95% Cl 97 - 100%
The positive samples were tested in the following stool matrix types: formalin (47), SAF (11), unpreserved frozen (14), Cary Blair (2), and C&S (3). The negative samples were tested in the following stool matrix types: formalin (71), SAF (49), unpreserved frozen (23), Cary Blair (2), C&S (12).
Additional retrospective studies
Performance of the test was compared to non-fluorescent microscopy (staining) at two external laboratories. At site 2, 47 retrospective samples were evaluated and demonstrated a Positive Percent Agreement (PPA) of 100% (26/26) and a Negative Percent Agreement (NPA) of 100% (21/21) versus Modified Acid-Fast Stain. At site 3, 281 retrospective SAF samples were evaluated and demonstrated a PPA of 92% (55/60) and a NPA of 90% (198/221) versus Modified Kinyoun Stain. Of the 23 negative samples (by Modified Kinyoun Stain) that tested positive on the Uni-Gold™M Cryptosporidium test, three of these samples subsequently tested positive for Cryptosporidium by DFA microscopy in agreement with the Uni-Gold™ Cryptosporidium result.
Prospective Study
The following table shows a summary of test performance compared against DFA microscopy with prospective samples at site 4.
| Cryptosporidium DFA | |||
|---|---|---|---|
| Site 4 | Cryptosporidium | + | - |
| Uni-Gold™ | 0 | 0 | |
| - | 0 | 378 |
Specificity: 100% (378/378) 95% Cl 99 - 100%
Due to infection prevalence, no positive samples were encountered during this prospective study. Samples were tested in the following sample matrix types: unpreserved fresh (153), unpreserved frozen (45), formalin (45), SAF (45), C&S (45), and Cary Blair (45).
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Expected Values
The performance of the Uni-Gold™ Cryptosporidium Test Kit was evaluated at four external laboratories. The 940 (prospective and retrospective) samples were collected from Hospitals throughout the US and Canada and consisted of both male and female patients of all ages from pediatric to adult. The retrospective study included 163 positive samples and 399 negative samples confirmed by microscopy. The prospective study included 378 samples which were subsequently confirmed negative by microscopy. There were no differences observed in clinical performance between males or females, or between pediatric or adult populations.
| SubstantialEquivalenceconclusion | The information submitted in this premarket notification is completeand supports a substantial equivalence decision. |
|---|---|
| ------------------------------------------ | -------------------------------------------------------------------------------------------------------------------------- |
2014-02-04 08:00:00 00-04-04-04 08:00:00 00:00 00-04-04 08:00:00 000 0000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
FEB 8 2013
Trinity Biotech C/O Bonnie DeJoy 5919 Farnsworth Ct. Carlsbad. CA 92008
Re: K121565
Trade Name: Uni-Gold™ Cryptosporidium Regulation Number: 21 CFR 866.3220 Regulation Name: Entamoeba histolytica serological reagents Regulatory Class: Class II Product Code: MHJ Dated: January 11, 2013 Received: January 14, 2013
Dear Ms. DeJoy:
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 that I Drinas intatutes 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 Or ic Part 807); as emage (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Bonnie B. DeJoy
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.
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 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,
Sally A. Hojvat
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
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Indications for Use Form
510(k) Number (if known): K121565
Device Name: Uni-Gold™ Cryptosporidium
Indications for Use:
Trinity Biotech Uni-Gold™ Cryptosporidium is a single use rapid immunoassay for the qualitative detection of Cryptosporidium parvum (C. parvum) antigens in human stool specimens. This test is intended for use with patients with gastrointestinal symptoms as an aid in the diagnosis of suspected Cryptosporidium gastrointestinal infections. As with other Cryptosporidium tests, results should be considered in conjunction with the clinical evaluation and medical history. For In-Vitro Diagnostic use.
Prescription Use (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 OF NEEDED)
Concurrence of CDRH, Office of Vitro Diagnostic Devices (OIVD)
coK-Rogueff, tho
Division Sign -Off Office of In Vitro Diagnostic Device Evaluation and Safety
KJ21565 510(K)
Page 1 of 1
§ 866.3220
Entamoeba histolytica serological reagents.(a)
Identification. Entamoeba histolytica serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies toEntamoeba histolytica in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identifyEntamoeba histolytica directly from clinical specimens. The identification aids in the diagnosis of amebiasis caused by the microscopic protozoan parasiteEntamoeba histolytica and provides epidemiological information on diseases caused by this parasite. The parasite may invade the skin, liver, intestines, lungs, and diaphragm, causing disease conditions such as indolent ulcers, an amebic hepatitis, amebic dysentery, and pulmonary lesions.(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.