(141 days)
Not Found
No
The device description and performance studies focus on a lateral flow immunoassay for detecting a specific protein. There is no mention of AI or ML in the text.
No.
The device is an in vitro diagnostic test used to detect a biomarker (MMP-9 protein) for dry eye, aiding in diagnosis. It does not treat or alleviate a medical condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that "InflammaDry is a rapid, immunoassay test for the visual, qualitative in vitro detection of elevated levels of the MMP-9 protein in human tears from patients suspected of having dry eye to aid in the diagnosis of dry eye in conjunction with other methods of clinical evaluation." This clearly indicates its role in the diagnostic process for dry eye.
No
The device description clearly outlines physical components including a sterile Sample Collector, an immunoassay test strip in a plastic Test Cassette housing, and Buffer in a vial. It is a physical in vitro diagnostic test.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is for "visual, qualitative in vitro detection of elevated levels of the MMP-9 protein in human tears". The term "in vitro" (meaning "in glass" or "in the lab") is a key indicator of an IVD.
- Sample Type: It analyzes human tears, which are a biological sample taken from the body.
- Purpose: The test is used "to aid in the diagnosis of dry eye in conjunction with other methods of clinical evaluation." This diagnostic purpose is a core function of IVDs.
- Device Description: The description details the components used to perform the test on the collected tear sample (sample collector, test cassette, buffer), which is consistent with an in vitro assay.
- Principle of Operation: The test is based on "lateral flow immunoassays," a common technology used in IVD tests to detect specific substances in biological samples.
- External Controls: The mention and description of external controls for verifying the performance of the test reagents and assay are standard practice for quality control in IVD testing.
All of these elements strongly indicate that the InflammaDry device is an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
InflammaDry is a rapid, immunoassay test for the visual, qualitative in vitro detection of elevated levels of the MMP-9 protein in human tears from patients suspected of having dry eye to aid in the diagnosis of dry eye in conjunction with other methods of clinical evaluation. This test is intended for prescription use at point-of-care sites.
InflammaDry External Controls are QC materials used for verifying the performance of the InflammaDry test reagents and assay. These controls can also be used to assist in operator training and troubleshoot invalid results.
Product codes
PFQ, JJX
Device Description
InflammaDry™ consists of three (3) parts: a sterile Sample Collector, an immunoassay test strip in a plastic Test Cassette housing, and Buffer in a vial. The Sample Collector is used to take a sample of human tears. The separately packaged and sterile Sample Collector has a contoured end with a Dacron fleece to collect the tear sample from the inside of the lower eyelid. The plastic housing of the Test Cassette body protects the strip from unintended physical influence. Additionally, the housing guarantees correct sample transfer onto the lateral flow assay strip. The Buffer vial contains a buffered salt solution containing proteins, detergents and preservatives. The Buffer functions as the solution that initiates the test, carries antigen through a microfiltration process to remove unwanted cellular debris, and transports the immune complex and the control conjugate to the Test and Control Lines on the test strip membrane.
InflammaDry External Controls are to be used with the InflammaDry test only and are intended to verify that the test reagents are working and that the test is performed correctly. Both Negative and Positive external controls for InflammaDrv™ are supplied as lyophilized powder in small glass vials with screw caps. 200 ul of recombinant MMP-9 in Stabilizing buffer solution is quickly frozen and lyophilized under vacuum. A soft and pliable plastic dropper bottle filled with a Dl water diluent is provided with each set of external controls. The InflammaDry external controls are sold as a separate catalog item.
Mechanism of action -
The InflammaDry™ test is based on the principle of lateral flow immunoassays using Direct Sampling Micro-Filtration technology. Matrix metalloproteinase-9 (MMP-9) present in the tear fluid is captured between two (2) highly specific anti-MMP-9 antibodies: a monoclonal mouse anti-MMP-9 antibody and a polyclonal goat antihuman antibody. This antigen-antibody complex is captured at an immobilized Test Line. The formation of a blue color line at the control zone line with a red color line at the test zone line is considered as a positive result, a blue color line at the control zone only is considered as a negative result, if a blue color line in the control zone does not appear the test is considered invalid.
The test is a disposable, rapid test requiring 10-15 minutes for a result.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human tears (from the inside of the lower eyelid)
Indicated Patient Age Range
18 years of age or older
Intended User / Care Setting
prescription use at point-of-care sites.
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
Clinical Studies: The InflammaDry Test underwent a clinical evaluation to determine the negative and positive agreement of the InflammaDry with clinical assessment of dry eye. The study design was a prospective, sequential, masked, clinical trial. Those patients who were clinically determined by an ophthalmic clinician to meet enrollment criteria were included in the study. The study enrolled 237 patients consisting of 164 females and 73 males between the ages of 18 and 94 years old with an average age of 53 years. Patients presented from both private practices and academic centers from various regions across the country.
Annotation Protocol: The InflammaDry was compared to the clinical assessment. Derived from the DEWS criteria, the clinical assessment was developed to represent a combination of symptoms and signs. The pivotal clinical trial used the same metrics for TBUT, Schirmer tear testing, and corneal staining as described in the DEWS criteria, however, conjunctival injection, conjunctival staining, and the presence of meibomian disease were not tested or used to characterize the severity of dry eye disease. In general, the worst severity for any sign tested determined the overall severity. Patients were categorized to the highest severity level at which all required criteria are satisfied. Patients who do not meet all the required criteria for a given severity grade will be considered to be at the next lower grade.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
In vitro Testing - Analytical Performance Studies - Precision studies
Precision studies were performed at three point-of-care sites using stabilizing buffer spiked to the following concentrations: negative (zero). cutoff, +/-25%, and +/-50%, of the cutoff. The samples were aliquoted, randomized and blinded, then given to each site. A total of 120 determinations were made at each concentration. Testing was performed in duplicate twice a day over 5 days by 6 intended use operators (2/site). The intended users performed the testing by following the instructions for use. Sample concentrations were confirmed by LC/MS/MS.
Determining the C50 Concentration
A series of MMP-9 antigen concentrations in tear fluid was tested in replicates of ten to determine the C50 (or cutoff) for the InflammaDry. Ten independent Readers scored the presence or absence of test lines for each test. The results of all Readers were summed and the frequency of positive results was determined to obtain the concentrations closest to C50(+/- 3%) Concentration.
Key Results: A concentration of 40 ng/mL of MMP-9 was the lowest concentration tested that met the definition of C50. This concentration produced a positive result 52% of the time. The closest concentration tested that did not meet the acceptance criteria was 35 ng/mL which produced a positive result 34% of the time.
Interfering Substances
Study Type: The effect of different eye drops on the analytical sensitivity and specificity of the InflammaDry™ tests was determined. The eye drops were evaluated with two different MMP-9 antigen concentrations, Cs (Cso - 25%) and Cas (Cso + 25%) in duplicate. Influence of the relevant proteins on sensitivity and specificity is also examined. Any positive or negative interfering substance identified by this testing was re-tested using C50 - 50%, and C50 +50%.
Key Results: The following eye medications did not show any interferences: Alcaine Alcon, "Azopt"-Alcon, Econopred Alcon, "Nevanac"-Alcon, "Pataday"-Alcon, Systaine"-Alcon, Tobra Dex, "Travatan"-Alcon, Alcon, Vigamox Alcon, "Acular LS"-Allergan, Alphagan Allergan, "Combigan"-Allergan, Elastat Allergan, "FML"-Allergan Lastacaft -Allergan, Lumigan Allergan, Optive"-Allergan, Pred Forte"-Allergan, Refresh Liquigel, Refreash Tears Allergan, Zymar Allergan, "Blink Tears"-Amo, Thera Tears AVS, Alrex B&L, Lotemax B&L, Zylet"-Bausch&Lomb, Gentamycin Sulfate-Falcon, Polymyxin B sulfate Falcon, "Timolol"-Falcon, "AzaSite"-Inspire, Bepreve-Ista, "Xibrom"-Ista, Optivar MedPDEnte, Truspot Merck, GenTeal"-Novartis, "Voltaren"-Novartis, "Zaditor"-Novartis, Visine Pfizer, Xalatan Pharmacia, human IgA (1 mg/ml), Sigma-Aldrich, human lactoferrin (1 mg/ml), Sigma-Aldrich, Transferrin (1 mg/ml), Betimol Vistakon.
However, the following medications show false positive or false negative results: Vistakon, Iquix; Vistakon, Quixin; Wilson, Proparacaine; and Trusopt.
Therefore, sponsor has the following limitations in the labeling: Patients should not be tested with InflammaDry if the following medications were administrated into the eyes within 2 hours of the testing of the ImflammaDry. Interferences medications: Vistakon, Iquix; Vistakon, Quixin; Wilson, Proparacaine; and Trusopt.
Certain medications such as systemic immunodulators, topical or oral steroids, cyclosporine, tetracycline and topical azithromycin are known to inhibit metalloproteinase activity. Use of these medications may lead to false negative results.
Cross Reactivity
Study Type: The cross-reactivity of the test was evaluated with microorganism culture and biomarkers that might be found in tear fluid.
Cross-reactants included: Adenovirus (1500 TCID50), IgE (250 ng/ml), MMP-1 (150 ng/ml), MMP-2 (150 ng/ml), MMP-3 (150 ng/ml), Tissue Inhibitor of MMP-1 (150 ng/ml), Tissue Inhibitor of MMP-2 (150 ng/ml).
Key Results: No cross reactivity was observed with either the organism or any of the biomarkers evaluated.
External Controls: Stability Studies
Three (3) different Stability Studies were conducted with the InflammaDry External Controls:
- An Accelerated Stability Study was performed on the Ivophilized external control vials at 45°C. The study indicates that there is no loss of activity at an extrapolated shelf life of two years.
- A stability study was performed on the InflammaDry reconstituted external controls. The reconstituted external controls showed no loss of activity at 25°C for one week.
- A Real Time Stability Study was performed on the InflammaDry External Controls. The study was performed on the lyophilized external control vials and indicated that there was no loss of activity at 27 months.
Clinical Studies
Study Type: A multicenter clinical study comparing InflammaDry to clinical assessment of dry eye based on DEWS criteria.
Sample Size: N = 237
Key Results: The multicenter clinical study depicted below demonstrated the following range of performance: Positive Agreement 66%-97% and Negative Agreement 97%-98%. At 2 sites Negative Agreement could not be calculated because there were no subjects without dry eye.
Site 1: Positive Agreement 97% (56/58) (88%, 99%), Negative Agreement 97% (31/32) (84%, 99%)
Site 2: Positive Agreement 76% (29/37) (62%, 90%), Negative Agreement 98% (47/48) (89%, 100%)
Site 3: Positive Agreement 67% (8/12) (39%, 86%), Negative Agreement N/A*
Site 4: Positive Agreement 66% (33/50) (51%, 79%), Negative Agreement N/A*
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Positive Agreement 66%-97%
Negative Agreement 97%-98%
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1540 Osmolality test system.
(a)
Identification. An osmolality test system is a device intended to measure ionic and nonionic solute concentration in body fluids, such as serum and urine. Osmolality measurement is used as an adjunct to other tests in the evaluation of a variety of diseases, including kidney diseases (e.g., chronic progressive renal failure), diabetes insipidus, other endocrine and metabolic disorders, and fluid imbalances.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
0
NOV 21 2013. K 132066
510(k) Summary of Safety and Effectiveness
1. Sponsor Rapid Pathogen Screening, Inc. 7227 Delainey Ct Sarasota, FL 34240 Phone: 941 556-1850 Fax: 941-556-6380 Registration Number: 3006602209
Contact Person: Mr. Douglas Bueschel VP, Quality Assurance & Regulatory Affairs Phone: 941 556-1869 Bueschel@rpsdetectors.com
2. Date Prepared November 20, 2013
November 20, 2013
Device Information Proprietary Name: InflammaDry™ Common Name: Dry eye test Product Code PFQ Regulations: 21CFR 862.1540 Classification: Class I, exempt, meets limitations of exemptions per 862.9 (c) (9) Panel: Chemistry (75)
| Proprietary Name: | InflammaDry™ External Controls |
|---|---|
| Common Name: | Quality controls |
| Regulations: | 21CFR 862.1660 |
| Classification: | Class I, reserved |
| Panel: | Chemistry (75) |
4. Predicate Device
For InflammaDry:
OcuSense, Inc., TearLab™ Osmolarity System (K083184)
For InflammaDry External Controls:
Predicate name: TearLab Control Solutions (K083184)
1
1
5. Device Description
Components-
InflammaDry™ consists of three (3) parts: a sterile Sample Collector, an immunoassay test strip in a plastic Test Cassette housing, and Buffer in a vial. The Sample Collector is used to take a sample of human tears. The separately packaged and sterile Sample Collector has a contoured end with a Dacron fleece to collect the tear sample from the inside of the lower eyelid. The plastic housing of the Test Cassette body protects the strip from unintended physical influence. Additionally, the housing guarantees correct sample transfer onto the lateral flow assay strip. The Buffer vial contains a buffered salt solution containing proteins, detergents and preservatives. The Buffer functions as the solution that initiates the test, carries antigen through a microfiltration process to remove unwanted cellular debris, and transports the immune complex and the control conjugate to the Test and Control Lines on the test strip membrane.
InflammaDry External Controls are to be used with the InflammaDry test only and are intended to verify that the test reagents are working and that the test is performed correctly. Both Negative and Positive external controls for InflammaDrv™ are supplied as lyophilized powder in small glass vials with screw caps. 200 ul of recombinant MMP-9 in Stabilizing buffer solution is quickly frozen and lyophilized under vacuum. A soft and pliable plastic dropper bottle filled with a Dl water diluent is provided with each set of external controls. The InflammaDry external controls are sold as a separate catalog item.
Mechanism of action -
The InflammaDry™ test is based on the principle of lateral flow immunoassays using Direct Sampling Micro-Filtration technology. Matrix metalloproteinase-9 (MMP-9) present in the tear fluid is captured between two (2) highly specific anti-MMP-9 antibodies: a monoclonal mouse anti-MMP-9 antibody and a polyclonal goat antihuman antibody. This antigen-antibody complex is captured at an immobilized Test Line. The formation of a blue color line at the control zone line with a red color line at the test zone line is considered as a positive result, a blue color line at the control zone only is considered as a negative result, if a blue color line in the control zone does not appear the test is considered invalid.
The test is a disposable, rapid test requiring 10-15 minutes for a result.
2
6. Intended Use
InflammaDry is a rapid, immunoassay test for the visual, qualitative in vitro detection of elevated levels of the MMP-9 protein in human tears from patients suspected of having dry eye to aid in the diagnosis of dry eye in conjunction with other methods of clinical evaluation. This test is intended for prescription use at point-of-care sites.
InflammaDry External Controls are QC materials used for verifying the performance of the InflammaDry test reagents and assay. These controls can also be used to assist in operator training and troubleshoot invalid results.
7. Substantial Equivalence
The InflammaDry test has similar Indications For Use to the predicate, TearLab Osmolarity System, in that they are indicated for the evaluation of human tears for assessing dry eye. The subject device and the predicate device are made from materials which have demonstrated satisfactory biocompatibility and are single use devices. Controls are available for both tests. Any technology differences between the InflammaDry test and the predicate do not raise any new questions of safety or effectiveness. Performance data demonstrate that the InflammaDry test is at least as safe and effective as the predicate device. In conclusion, the InflammaDry test is substantially equivalent to other legally marketed tear collection and measurement device(s).
InflammaDry™ and TearLab Osmolarity System Predicate Device Table 1.: Comparison Chart
| | InflammaDry | TearLab Osmolarity System
(K083184)
Includes Control Solutions |
|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Rapid Pathogen Screening, Inc. | OcuSense, Inc. |
| Indications | InflammaDry is a rapid,
immunoassay test for the visual,
qualitative in vitro detection of
elevated levels of the MMP-9 protein
in human tears from patients
suspected of having dry eye to aid in
the diagnosis of dry eye in
conjunction with other methods of
clinical evaluation. | The TearLab Osmolarity
System is intended to measure
the osmolarity of human tears
to aid in the diagnosis of
patients with signs or
symptoms of dry eye disease,
in conjunction with other
methods of clinical evaluation. |
| Materials | Plastic housings, membrane, glass fiber absorbent tip and waste pad, foil pouches, MMP-9 antibody gold conjugate, dacron fleece and buffer solution. Phenol red dye added to the Sample Collector dacron fleece. | The device consists of the following components and accessories: One TearLab Reader, Two TearLab Pens, Two TearLab Electronic Check Cards, Single Use TearLab Osmolarity Test cards, and TearLab Control Solutions. |
| Product Code | PFQ | OND, JJX |
| Rx / OTC | Rx | Rx |
| Sterile | Yes, Sample Collector by gamma radiation | No; test cards are hygienically clean. |
| Kit Composition | Sample Collector and Test Cassette sealed in foil pouches and a vial of buffer | The device consists of the following components and accessories: One TearLab Reader, Two TearLab Pens, Two TearLab Electronic Check Cards, Single Use TearLab Osmolarity Test cards, and TearLab Control Solutions. |
| Technology | Lateral Flow Immunoassay | The TearLab Osmolarity Test utilizes an impedance measurement of tear fluid to provide a calculated measurement of osmolarity. |
| Antigen Detected | Matrix Metalloproteinase 9 (MMP-9) | Not applicable |
| Duration of Contact | 40 ng/ml | 275 - 400 mOsms/L |
| Test Line Color (after | Red | NA |
| Control Line Color (after result) | Blue | NA |
| Bench Testing | Yes, Bench Testing Performed | Yes |
| Animal Testing | Not Applicable | No |
| CLIA Status | Not waived | CLIA Waived |
| Mechanism
Of Action | The InflammaDry test is based on
the principle of lateral flow
immunoassay using Direct
Sampling Micro-Filtration
technology. Matrix Metalloproteinase
9 (MMP-9) present in the tear is
captured between a monoclonal
anti- MMP-9 antibody conjugated to
colloidal gold and biotinylated
polyclonal anti- MMP-9. This
antigen-antibody complex is
captured by NeutrAvidin immobilized
as the Test Line.
The test is a disposable, rapid test
requiring 10-15 minutes for a result. | The TearLab Osmolarity Test
utilizes a temperature-corrected
impedance measurement to
provide an indirect assessment
of osmolarity. After applying a
lot-specific calibration curve,
osmolarity is calculated and
displayed as a quantitative
numerical value. |
| Specimen Types | Human tears | Human tears |
| Biological derived | Contains antibodies | NA |
| Site preparation | None | None. |
| External Controls:
Form
Function / purpose | Lyophilized
Verify performance of InflammaDry
test reagents and assay; assist with
operator training; troubleshoot
invalid results. | Liquid
Monitor day-to-day test variation;
lot-to-lot test kit performance;
Assist with operator training:
Trouble shoot invalid results. |
| Test Results | Qualitative | Quantitative |
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5
8. Performance Testing
In vitro Testing -
The InflammaDry test completed a series of analytical bench tests for sensitivity and specificity.
Analytical Performance Studies -
Precision studies
Precision studies were performed at three point-of-care sites using stabilizing buffer spiked to the following concentrations: negative (zero). cutoff, +/-25%, and +/-50%, of the cutoff. The samples were aliquoted, randomized and blinded, then given to each site. A total of 120 determinations were made at each concentration. Testing was performed in duplicate twice a day over 5 days by 6 intended use operators (2/site). The intended users performed the testing by following the instructions for use. Sample concentrations were confirmed by LC/MS/MS.
| Negative | -50% | -25% | Cutoff | +25% | +50% | ||
|---|---|---|---|---|---|---|---|
| Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | ||
| Site 1 | Op 1 | 20/0 | 19/1 | 18/2 | 4/16 | 0/20 | 0/20 |
| Op 2 | 20/0 | 19/1 | 10/10 | 4/16 | 2/18 | 0/20 | |
| Site 2 | Op 1 | 20/0 | 20/0 | 17/3 | 10/10 | 3/17 | 0/20 |
| Op 2 | 20/0 | 20/0 | 18/2 | 12/8 | 2/18 | 3/17 | |
| Site 3 | Op 1 | 20/0 | 20/0 | 19/1 | 10/10 | 2/18 | 0/20 |
| Op 2 | 20/0 | 20/0 | 18/2 | 12/8 | 2/18 | 0/20 | |
| Combined | 120/0 | 118/2 | 100/20 | 52/68 | 11/109 | 3/117 |
Determining the C50 Concentration
A series of MMP-9 antigen concentrations in tear fluid was tested in replicates of ten to determine the C50 (or cutoff) for the InflammaDry. Ten independent Readers scored the presence or absence of test lines for each test. The results of all Readers were summed and the frequency of positive results was determined to obtain the concentrations closest to C50(+/- 3%) Concentration.
A concentration of 40 ng/mL of MMP-9 was the lowest concentration tested that met the definition of C50. This concentration produced a positive result 52% of the time. The closest concentration tested that did not meet the acceptance criteria was 35 ng/mL which produced a positive result 34% of the time.
6
Interfering Substances
The effect of different eye drops on the analytical sensitivity and specificity of the InflammaDry ™ tests was determined. The eye drops were evaluated with two different MMP-9 antigen concentrations, Cs (Cso - 25%) and Cas (Cso + 25%) in duplicate. Influence of the relevant proteins on sensitivity and specificity is also examined. Any positive or negative interfering substance identified by this testing was re-tested using C50 - 50%, and C50 +50%.
The following eye medications were tested for interference in human teares at the cutoff level and the respective medication. The following medications did not show any interferences:
Alcaine Alcon, "Azopt"-Alcon, Econopred Alcon, "Nevanac"-Alcon, "Pataday"-Alcon, Systaine"-Alcon, Tobra Dex, "Travatan"-Alcon, Alcon, Vigamox Alcon, "Acular LS"-Allergan, Alphagan Allergan, "Combigan"-Allergan, Elastat Allergan, "FML"-Allergan Lastacaft -Allergan, Lumigan Allergan, Optive"-Allergan, Pred Forte"-Allergan, Refresh Liquigel, Refreash Tears Allergan, Zymar Allergan, "Blink Tears"-Amo, Thera Tears AVS, Alrex B&L, Lotemax B&L, Zylet"-Bausch&Lomb, Gentamycin Sulfate-Falcon, Polymyxin B sulfate Falcon, "Timolol"-Falcon, "AzaSite"-Inspire, Bepreve-Ista, "Xibrom"-Ista, Optivar MedPDEnte, Truspot Merck, GenTeal"-Novartis, "Voltaren"-Novartis, "Zaditor"-Novartis, Visine Pfizer, Xalatan Pharmacia, human IgA (1 mg/ml), Sigma-Aldrich, human lactoferrin (1 mg/ml), Sigma-Aldrich, Transferrin (1 mg/ml), Betimol Vistakon
- However, the following medications show false positive or false negative results: Vistakon, Iquix; Vistakon, Quixin; Wilson, Proparacaine; and Trusopt.
Therefore, sponsor has the following limitations in the labeling:
Patients should not be tested with InflammaDry if the following medications were administrated into the eyes within 2 hours of the testing of the ImflammaDry. Interferences medications: Vistakon, Iquix; Vistakon, Quixin; Wilson, Proparacaine; and Trusopt.
Certain medications such as systemic immunodulators, topical or oral steroids, cyclosporine, tetracycline and topical azithromycin are known to inhibit metalloproteinase activity. Use of these medications may lead to false negative results.
7
Cross Reactivity
The cross-reactivity of the test was evaluated with microorganism culture and biomarkers that might be found in tear fluid. The cross-reactants included:
| Adenovirus | 1500 TCID50 |
|---|---|
| lgE | 250 ng/ml |
| MMP-1 | 150 ng/ml |
| MMP-2 | 150 ng/ml |
| MMP-3 | 150 ng/ml |
| Tissue Inhibitor of MMP-1 | 150 ng/ml |
| Tissue Inhibitor of MMP-2 | 150 ng/ml |
No cross reactivity was observed with either the organism or any of the biomarkers evaluated.
External Controls:
.
Three (3) different Stability Studies were conducted with the InflammaDry External Controls:
-
- An Accelerated Stability Study was performed on the Ivophilized external control vials at 45°C. The study indicates that there is no loss of activity at an extrapolated shelf life of two years.
-
- A stability study was performed on the InflammaDry reconstituted external controls. The reconstituted external controls showed no loss of activity at 25°C for one week.
-
- A Real Time Stability Study was performed on the InflammaDry External Controls. The study was performed on the lyophilized external control vials and indicated that there was no loss of activity at 27 months.
Biocompatibility is supported by literature references.
Animal Studies - Not Applicable.
Clinical Studies
The InflammaDry Test underwent a clinical evaluation to determine the negative and positive agreement of the InflammaDry with clinical assessment of dry eye. The study design was a prospective, sequential, masked, clinical trial. Those patients who were clinically determined by an ophthalmic clinician to meet enrollment criteria were included in the study. The study enrolled 237 patients consisting of 164 females and 73 males between the ages of 18 and 94 years old with an average age of 53 years. Patients presented from both private practices
8
8
and academic centers from various regions across the country. Although 257 patients were recruited, seventeen (17) patients were excluded for a protocol deviation.
The protocol deviation involved patients receiving topical ocular anesthetic prior to the evaluation of the tear break up time (TBUT) and corneal staining, potentially accelerating the TBUT and inducing corneal staining.
Inclusion Criteria
- 18 years of age or older
- Patient voluntarily reported at least 1 episode of any of the following ocular symptoms . during the last month:
-
- Burning or stinging
-
- Sandy or gritty feeling
-
- Foreign body sensation
-
- Tearing
-
- Light sensitivity
-
- Intermittent or fluctuating vision
-
- Tired eyes
-
Exclusion Criteria
- Allergy to cornstarch or Dacron .
- . Allergy to topical anesthetic or fluorescein dve
- . Prior eye injury, trauma, or ocular surgery within the last 3 months
- . Known blockage of the lacrimal drainage system
- . Contact lens wear in the last month
- . Previous corneal refractive surgery including RK, LASIK or PRK surgery
- . Have an active ocular infection or history of a recent ocular infection in the last month
- . Have active intraocular inflammation or history of intraocular inflammation, e.g. Uveitis
- Use of oral doxycycline, corticosteroids, or immunomodulators in the last month .
- Have received topical ocular corticosteroids, topical Nonsteroidal (NSAIDs) therapy, o or topical ocular cyclosporine in the last month
- . Pregnant or lactating
- · Use of any topical ophthalmic medications, including artificial tears 2 hours prior to enroliment
Study testing was done on the subject's more symptomatic eye (if no difference existed symptomatically between the two eyes, the right eye was tested). Each subject underwent
9
the following sequence of testing: Each patient had the following tests performed: InflammaDry, tear break up time (TBUT), Schirmer tear testing, and corneal staining.
The InflammaDry was compared to the clinical assessment in the table below. Derived from the DEWS criteria, the clinical assessment was developed to represent a combination of symptoms and signs. The pivotal clinical trial used the same metrics for TBUT, Schirmer tear testing, and corneal staining as described in the DEWS criteria, however, conjunctival injection, conjunctival staining, and the presence of meibomian disease were not tested or used to characterize the severity of dry eye disease. In general, the worst severity for any sign tested determined the overall severity. Symptoms are known to be poorly correlated with signs with even the most severe dry eye patients often reporting little to no symptoms. Patients were categorized to the highest severity level at which all required criteria are satisfied. Patients who do not meet all the required criteria for a given severity grade will be considered to be at the next lower grade.
| | Negative | Mild | Moderate | Moderately
Severe | Severe |
|----------------------|----------|---------|----------|----------------------|------------------|
| Clinical Testing | Control | Grade 1 | Grade 2 | Grade 3 | Grade 4 |
| OSDI score | દ્વાર | ≥ 13 | 2 13 | ≥ 13 | ≥ 13 |
| TBUT (sec)8 | > 10 | 10 | 10 seconds, Schirmer is . >10mm, Staining is none
- Grade 1 (Mild) is when OSDI score is ≥ 13, TBUT is