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.

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.

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.

AI/ML Overview

Here's a summary of the acceptance criteria and study details for the InflammaDry™ device, extracted from the provided text:

Acceptance Criteria and Device Performance

The provided document does not explicitly state pre-defined acceptance criteria for the clinical performance regarding sensitivity, specificity, accuracy, positive predictive value, or negative predictive value. Instead, it presents observed performance metrics. The "Device Performance" section of the clinical study simply states the range of performance demonstrated in the multicenter study.

However, based on the provided data, we can infer that the device demonstrated the following performance ranges in comparison to clinical assessment:

Performance Metric	Range of Performance
Positive Agreement	66% - 97%
Negative Agreement	97% - 98%

Study Information

1. A table of acceptance criteria and the reported device performance

As mentioned above, explicit acceptance criteria were not listed, but the observed performance is tabulated above.

2. Sample size used for the test set and the data provenance

Sample Size: 237 patients were initially enrolled, but 17 were excluded due to a protocol deviation, resulting in a test set of 220 patients. (Calculated from 237 - 17 = 220, though the individual site totals sum to 237) Correction: The text explicitly states "N = 237" with individual site totals summing to 237 (90+85+12+50), so the 17 excluded patients are likely accounted for within the 237 enrolled if the protocol deviation led to their exclusion from analysis rather than just the enrollment count.
Data Provenance: Prospective, sequential, masked, clinical trial conducted at academic centers and private practices from various regions across the United States.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not explicitly stated, but clinical assessment for dry eye was performed by "ophthalmic clinician[s]" at each study site. The number of individual clinicians is not specified.
Qualifications of Experts: "Ophthalmic clinician" - no further specific qualifications (e.g., years of experience, subspecialty) are provided.

4. Adjudication method for the test set

Adjudication Method: Not explicitly stated. The "clinical assessment" for dry eye was presumably developed and applied by the ophthalmic clinicians. The DEWS criteria, with some modifications, were used to categorize patients. There is no mention of a separate adjudication panel or method for resolving discrepancies among clinicians.

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

MRMC Study: No. This device is a standalone diagnostic test (immunoassay) for MMP-9 levels, not an AI-assisted interpretation tool for human readers. Therefore, an MRMC comparative effectiveness study regarding human reader improvement with AI assistance is not applicable.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Standalone Performance: Yes, the clinical study directly evaluated the performance of the InflammaDry™ device (algorithm/test strip only) against the clinical assessment (ground truth). The results in the tables for "Device Performance" are based on the device's qualitative output (positive/negative) compared to the clinical assessment.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Ground Truth Type: Clinical assessment of dry eye based on a combination of symptoms and signs, derived from the DEWS criteria. This involved an "ophthalmic clinician" evaluating OSDI score, TBUT, Schirmer tear testing, and corneal staining.

8. The sample size for the training set

Sample Size: Not explicitly mentioned in the provided text. The document focuses on the performance testing (analytical bench tests and clinical study), implying that any training would have occurred prior to these evaluations.

9. How the ground truth for the training set was established

Ground Truth Establishment: Not explicitly mentioned in the provided text.

Summary

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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)

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5. Device Description

Components-

Mechanism of action -

The test is a disposable, rapid test requiring 10-15 minutes for a result.

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6. Intended Use

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 ofelevated levels of the MMP-9 proteinin human tears from patientssuspected of having dry eye to aid inthe diagnosis of dry eye inconjunction with other methods ofclinical evaluation.	The TearLab OsmolaritySystem is intended to measurethe osmolarity of human tearsto aid in the diagnosis ofpatients with signs orsymptoms of dry eye disease,in conjunction with othermethods 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	< 1 minute	Seconds
Limit of Detection	> 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
MechanismOf Action	The InflammaDry test is based onthe principle of lateral flowimmunoassay using DirectSampling Micro-Filtrationtechnology. Matrix Metalloproteinase9 (MMP-9) present in the tear iscaptured between a monoclonalanti- MMP-9 antibody conjugated tocolloidal gold and biotinylatedpolyclonal anti- MMP-9. Thisantigen-antibody complex iscaptured by NeutrAvidin immobilizedas the Test Line.The test is a disposable, rapid testrequiring 10-15 minutes for a result.	The TearLab Osmolarity Testutilizes a temperature-correctedimpedance measurement toprovide an indirect assessmentof osmolarity. After applying alot-specific calibration curve,osmolarity is calculated anddisplayed as a quantitativenumerical value.
Specimen Types	Human tears	Human tears
Biological derived	Contains antibodies	NA
Site preparation	None	None.
External Controls:FormFunction / purpose	LyophilizedVerify performance of InflammaDrytest reagents and assay; assist withoperator training; troubleshootinvalid results.	LiquidMonitor 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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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.

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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.

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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:

1. 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.
1. 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.
1. 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

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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:
- 1. Burning or stinging
- 1. Sandy or gritty feeling
- 1. Foreign body sensation
- 1. Tearing
- 1. Light sensitivity
- 1. Intermittent or fluctuating vision
- 1. 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

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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	ModeratelySevere	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	ર ર	0(immediate)
Schirmer (mm/5 min)8	>10	< 10	≤10	< ર	ಸ್ ನ
Staining (0-5)9	None	None	1-2	ਤੇ	24

Clinical Results

Site 1	Grade					Total
	4	3	2	1	0
InflammaDry+	0	0	15	41	1	57
InflammaDry-	0	0	0	2	31	33
Total	0	0	15	43	32	90

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Site 2	Grade					Total
	4	3	2	1	0
InflammaDry +	0	7	21	1	1	30
InflammaDry -	0	0	0	7	47	55
Total		7	21	9	48	85

Site 3	Grade				Total
	4	3	2	1
InflammaDry +	0	0	4	4	8
InflammaDry -	0	0	3	1	4
Total	0	0	7	5	12

Site 4	Grade				Total
	4	3	2	1
InflammaDry +	1	11	20	1	33
InflammaDry -	0	2	13	2	17
Total	1	13	33	3	50

Grade is assessed based on OSDI, 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.

Grade 0 (Negative Control)is when OSDSI is ≤13, TBUT is >10 seconds, Schirmer is . >10mm, Staining is none
Grade 1 (Mild) is when OSDI score is ≥ 13, TBUT is <10 seconds, Schirmer test is . <10 mm, Staining is none

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Grade 2 (Moderate) is when OSDSI is ≥13, TBUT is ≤10 seconds, Schirmer is ≤10 . mm, Staining is 1-2
Grade 3 (Moderately Severe) is when OSDSI is ≥13, TBUT is <5 seconds, Schirmer . is ≤5 mm, Staining is 3
Grade 4 (Severe ) is when OSDS! is ≥13, TBUT is 0 seconds (immediate), Schirmer . is ≤2 mm, Staining is ≥4

Device Performance:

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.

				ClinicalAssessment	Positive %agreement	Negative %agreement
N = 237			OSDI** + TBUT +Schirmer + Staining		વેટી જે જે જે જે જે જે જે જે જેવી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્confidenceinterval	વેરૂ%confidenceinterval
			Positive	Negative
Site 1InflammaDry		Positive	56	1	97% (56/58)(88%, 99%)	97% (31/32)(84%, 99%)
	Negative	2	31

Site 2	InflammaDry	Positive	29	1	76% (29/37)(62%, 90%)	98% (47/48)(89%, 100%)
		Negative	ರಿ	47
			:"	:・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
Site 3	InflammaDry	Positive	8	0	67% (8/12)(39%, 86%)	N/A*
		Negative	4	0
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・		好彩 - ------------------------------------------------------------------------------------------------------------------------------------------------------------------------		్లో ప్లﺮ ﻣﻦ ﺍﻻﺗﻔﺎﻕ
Site 4	InflammaDry	Positive	રૂઝ	0	66% (33/50)(51%, 79%)	N/A*
	Negative	17	0

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*N/A = not available. Negative Agreement cannot be calculated because there were no subjects without dry eye.

** 11 patients were assessed to be positive for mild dry eye based on the OSDI (OSDI ≥ 13) without any associated positive objective test results

9. Conclusion

Rapid Pathogen Screening, Inc. believes that, as a result of the bench testing, clinical testing and supporting biocompatibility information, InflammaDry" is safe and effective for use in the detection of Dry Eye disease. InflammaDry is substantially equivalent to the predicate device, TearLab™ Osmolarity System (K083184).

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Image /page/13/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features the department's emblem, which is a stylized representation of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the emblem.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002

November 21, 2013

RAPID PATHOGEN SCREENING, INC. DOUGLAS BUESCHEL VP, QUALITY ASSURANCE AND REGULATORY AFFAIRS 7227 DELAINEY COURT SARASOTA FL 34240

Re: K132066

Trade/Device Name: InflammaDry and InflammaDry External Controls Regulation Number: 21 CFR 862.1540 Regulation Name: Osmolality test system Regulatory Class: I exempt, meets limitations of exemptions, 21 CFR 862.9 (b) and (c) (9) Product Code: PFQ, JJX Dated: November 19, 2013 Received: November 20, 2013

Dear Mr. Bueschel:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact 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/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDeviccs/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carol Benson -S for

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K132066

Device Name: InflammaDry™, InflammaDry™ External Controls

Indications for Use:

Prescription Use X (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 In Vitro Devices and Radiologic Health (OIR)

YungMDchan-S

Division Sign-Off Office of In Vitro Device and Radiologic Health

510(k) K132066

Page 1 of _1

Regulation Number and Section

§ 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.