(255 days)
Not Found
No
The device is described as a rapid lateral flow immunoassay, which is a traditional diagnostic technology that does not typically incorporate AI/ML. There are no mentions of AI, ML, image processing, or any computational analysis of results. The performance studies focus on traditional metrics like sensitivity and specificity compared to existing methods.
No.
This device is an in-vitro diagnostic test intended to aid in the diagnosis of suspected Cryptosporidium gastrointestinal infections by detecting antigens in stool specimens, not to provide therapy.
Yes
The device is described as "an aid in the diagnosis of suspected Cryptosporidium gastrointestinal infections" and is explicitly stated as "For In-Vitro Diagnostic use."
No
The device description clearly states it is a "single use, rapid, lateral flow immunoassay" with a "test strip" and "plastic housing," indicating it is a physical hardware device, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states "For In-Vitro Diagnostic use" in the Intended Use / Indications for Use section. This is the primary indicator that the device is intended for use outside of the body to examine specimens for diagnostic purposes.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MHJ
Device Description
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.
The Cryptosporidium nitrocellulose membrane test strip (above) consists of:
A) Mouse anti-Cryptosporidium parvum is coated onto the test line region of the test strip.
B) Goat anti-mouse IgG is coated onto the control line region of the test strip.
C) Mouse anti-Cryptosporidium parvum antibodies and Mouse IgG antibodies are conjugated to red latex particles and dried onto inert glass fiber (Conjugate pad), which is inserted into the test strip below the nitrocellulose zone.
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 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.
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human stool specimens (fecal specimens)
Indicated Patient Age Range
all ages from pediatric to adult
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
Description of the test set: Retrospective and prospective human stool samples.
Sample size:
Precision/Reproducibility Study: 12 blind proficiency panel members (4 Low Positive, 4 High Positive, 4 Negative samples). Tested for 5 days, 2 runs/day, by 2 technicians, totaling 20 replicates per site per panel member (60 replicates total for each panel member across 3 sites).
External laboratory comparison study: 299 retrospective samples (37 unpreserved frozen, 4 Cary Blair, 159 SAF, 99 formalin).
Cross Reactivity Study: Samples containing various organisms.
Interfering Substance Study: Stool samples spiked with potential interfering substances.
Sensitivity/Specificity Study (DFA microscopy comparison): 234 retrospective samples (77 positive, 157 negative). Stool matrix types for positive samples: 47 formalin, 11 SAF, 14 unpreserved frozen, 2 Cary Blair, 3 C&S. Stool matrix types for negative samples: 71 formalin, 49 SAF, 23 unpreserved frozen, 2 Cary Blair, 12 C&S.
Additional Retrospective Studies (Non-fluorescent microscopy comparison):
Site 2: 47 retrospective samples.
Site 3: 281 retrospective SAF samples.
Prospective Study: 378 prospective samples. Sample matrix types: 153 unpreserved fresh, 45 unpreserved frozen, 45 formalin, 45 SAF, 45 C&S, 45 Cary Blair.
Expected Values Study: 940 (prospective and retrospective) samples (163 positive, 399 negative confirmed by microscopy in retrospective study; 378 negative confirmed by microscopy in prospective study).
Data source: 3 external laboratories (for initial comparison study), 4 external laboratories (for sensitivity/specificity study and expected values study), and 1 internal site (for precision/reproducibility study). Samples collected from Hospitals throughout the US and Canada.
Annotation protocol:
Precision/Reproducibility Study: 100% reproducibility observed at all sites for all days using the blind panel sample set.
External laboratory comparison study: Percent agreement with a commercially available lateral flow test.
Cross Reactivity Study: No cross reactivity observed with listed organisms.
Interfering Substance Study: No test interference observed by any of the compounds at the concentrations tested.
Sensitivity/Specificity Study: Compared against DFA microscopy.
Additional Retrospective Studies: Compared against Modified Acid-Fast Stain and Modified Kinyoun Stain.
Prospective Study: Compared against DFA microscopy. Samples subsequently confirmed negative by microscopy.
Expected Values Study: Confirmed by microscopy.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision / Reproducibility Study:
Study type: Intra-run precision/reproducibility study.
Sample size: 12 blind proficiency panel members (4 Low Positive, 4 High Positive, 4 Negative samples). Each panel member had 60 replicates total across 3 sites (20 per site).
Key results: 100% reproducibility 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.
External Laboratory Comparison Study:
Study type: Comparison of Uni-Gold™ Cryptosporidium versus a commercially available lateral flow test.
Sample size: 299 retrospective samples (unpreserved frozen, Cary Blair, SAF, formalin).
Key results:
Site 1: 100% Positive Agreement, 98.1% Negative Agreement.
Site 2: 100% Positive Agreement, 100% Negative Agreement.
Site 3: 96.4% Positive Agreement, 38.6% Negative Agreement.
At Site 3, for discrepant samples where Uni-Gold™ Cryptosporidium was positive and comparator negative (51 samples), 30 were positive by Modified Kinyoun Stain light microscopy and 3 by DFA microscopy, agreeing with Uni-Gold™. For the one sample where Uni-Gold™ was negative and comparator positive, it was negative by Modified Kinyoun Stain microscopy, agreeing with Uni-Gold™.
Cross Reactivity Study:
Study type: Evaluation of cross-reactivity with various organisms.
Key results: No cross reactivity observed using samples containing the listed organisms. Cross Rectivity has not been established for E. dispar.
Interfering Substance Study:
Study type: Evaluation of analytical specificity in stool samples containing potentially interfering substances.
Key results: No test interference was observed by any of the compounds at the concentrations tested.
Sensitivity / Specificity Study (DFA microscopy comparison):
Study type: Comparison against DFA microscopy.
Sample size: 234 retrospective samples (77 positive, 157 negative).
Sensitivity: 100% (77/77) 95% CI 94 - 100%
Specificity: 100% (157/157) 95% Cl 97 - 100%
Additional Retrospective Studies (Non-fluorescent microscopy comparison):
Study type: Comparison against non-fluorescent microscopy (staining).
Sample size: Site 2: 47 retrospective samples; Site 3: 281 retrospective SAF samples.
Key results:
Site 2: Positive Percent Agreement (PPA) of 100% (26/26) and a Negative Percent Agreement (NPA) of 100% (21/21) versus Modified Acid-Fast Stain.
Site 3: 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™ Cryptosporidium test, three subsequently tested positive for Cryptosporidium by DFA microscopy.
Prospective Study:
Study type: Performance compared against DFA microscopy with prospective samples.
Sample size: 378 prospective samples.
Specificity: 100% (378/378) 95% Cl 99 - 100%
Key results: Due to infection prevalence, no positive samples were encountered during this prospective study.
Expected Values Study:
Study type: Evaluation of clinical performance.
Sample size: 940 (prospective and retrospective) samples.
Key results: No differences observed in clinical performance between males or females, or between pediatric or adult populations.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 100% (77/77) 95% CI 94 - 100%
Specificity: 100% (157/157) 95% Cl 97 - 100% (based on DFA microscopy comparison)
Specificity: 100% (378/378) 95% Cl 99 - 100% (based on prospective study)
Positive Percent Agreement (PPA): 100% (26/26) versus Modified Acid-Fast Stain.
Negative Percent Agreement (NPA): 100% (21/21) versus Modified Acid-Fast Stain.
PPA: 92% (55/60) versus Modified Kinyoun Stain.
NPA: 90% (198/221) versus Modified Kinyoun Stain.
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.
Remel Xpect® Cryptosporidium (510K #: K031965)
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
§ 866.3220
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.
0
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જન્
510(k) Summary – Uni-Gold™ Cryptosporidium
FEB 8 2013
| 510(k)
Number
| Assigned: | K121565 |
|---|---|
| Introduction: | Trinity Biotech hereby submits this 510(k) summary for the Uni-GoldTM |
| Cryptosporidium Rapid Lateral Flow Test Kit in accordance with the | |
| requirements of 21 CFR 807.92(C). | |
| Submitter's | |
| Identification: | |
| 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. Com
716-483-3851 Extension 1030 |
|----------|------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| | Fax: | 716-488-1990 |
| Date
Summary
| Prepared: | February 4, 2013 | ||
|---|---|---|---|
| Device Trade | |||
| Name: | Uni-Gold™ Cryptosporidium | ||
| Classification | |||
| Name: | Entamoeba histolytica serological reagents. | ||
| Cryptosporidium SPP 866.3220 Code MHJ | |||
| Classification | |||
| Product | |||
| Code: | MHJ | ||
| Intended 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. |
1
| Predicate
| Device | Remel Xpect® Cryptosporidium (510K #: K031965) | ||||
|---|---|---|---|---|---|
| Device | |||||
| Description | 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. (Picture A) | |||||
| Picture A- Cryptosporidium Test Strip - 5 mm x 60 mm | |||||
| Sample Pad | |||||
| Conjugate Pad | |||||
| Backing | |||||
| Absorbent Pad | |||||
| Nitrocellulose | |||||
| Plastic Housing device | |||||
| The Cryptosporidium nitrocellulose membrane test strip (above) consists of: | |||||
| A)Mouse anti-Cryptosporidium parvum is coated onto the test line region of the | |||||
| test 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 antibodies | |||||
| C) | |||||
| are conjugated to red latex particles and dried onto inert glass fiber | |||||
| (Conjugate pad), which is inserted into the test strip below the nitrocellulose | |||||
| zone. | |||||
| 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
.
2
Image /page/2/Picture/1 description: The image shows the logo for Trinity Biotech. The logo consists of a triangle shape on the left, followed by the text "Trinity Biotech" in a sans-serif font. Below the company name, in smaller letters, is the text "YOUR DIAGNOSTICS PARTNER".
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
3
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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-K031965
Xpect® Cryptosporidium | Trinity Biotech
Uni-Gold ™ Cryptosporidium |
|--------------------------------------|--|----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Comparison Table | | | |
| Intended Use | | Detection of
Cryptosporidium specific
antigen in fecal specimens. | Detection of Cryptosporidium
antigens in stool (fecal)
specimens. |
| Technology | | Qualitative immune
chromatographic assay | Qualitative immune
chromatographic assay |
| Capture
antibodies on
membrane | | Rabbit anti-
Cryptosporidium, goat anti-
mouse IgG | Mouse anti-Cryptosporidium
parvum, goat anti-mouse IgG |
| Material:
Membrane | | Mylar-backed
Nitrocellulose | Nitrocellulose |
| Conjugate
antibodies | | Monoclonal anti-
cryptosporidium | Mouse anti-Cryptosporidium
parvum, mouse IgG |
| Material:
Conjugate | | Anti-mouse and anti-
Cryptosporidium colored
microparticles diluted in
buffer | Anti-Cryptosporidium and
Mouse IgG colored latex dried
onto conjugate pad |
| Specimen
Types | | Human Stool preserved in
10% formalin, SAF, or Cary
Blair | Human Stool: fresh/frozen or
preserved in 10% formalin,
SAF or Cary Blair, or C&S
Transport Medium |
| Sample
volume | | 100 μl | 2 drops- approximately 40-60
μl |
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Image /page/4/Picture/0 description: The image shows the logo for Trinity Biotech. The logo consists of a triangle shape on the left and the words "Trinity Biotech" on the right. Below the company name are the words "YOUR DIAGNOSTICS PARTNER".
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.
5
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).
7
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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.
| Substantial
Equivalence
conclusion | The information submitted in this premarket notification is complete
and 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
8
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
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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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
10
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)
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