(198 days)
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.
The TearLab Osmolarity System is intended to measure the osmolarity of human tears to aid in the cliagnosis of patients with signs or symptoms of dry eye disease, in conjunction with other methods of clinical evaluation. The device consists of the following components and accessories: One Tearl.ab Reader, Two TearLab Pens, Two TearLab Electronic Check Cards, Sinqle Use TearLab Osmolarity Test Cards, and TearLab Control Solutions.
The TearLab Osmolarity Test Card, in conjunction with the TearLab Osmolarity System, provides a quick and simple method for determining tear osmolarity using nanoliter (nL) volumes of tear fluid collected directly from the eyelid margin.
To perform a test, a new Test Card containing a microfluidic capillary channel is attached onto the Pen. The tip of the Test Card is touched to the inferior tear meniscus located above the lower eyelid and collects 40-50 nanoliters of tear fluid by passive capillary action.
After a successful collection, the Pen in conjunction with the electrodes embedded on the Test Card, measures and stores the tear fluid impedance. The Pen is then docked to the Reader.
The Reader downloads impedance data from the Pen in order to calculate and display the final osmolarity as a numerical value displayed in units of mOsms/L.
The TearLab Osmolarity System simplifies the tear collection process by reducing the required specimen volume to nanoliters, eliminating the need to transfer tear fluid and reducing the risk of evaporation.
Acceptance Criteria and Study for TearLab™ Osmolarity System
This document outlines the acceptance criteria and the study conducted to demonstrate the performance of the TearLab™ Osmolarity System.
1. Acceptance Criteria and Reported Device Performance
The provided document focuses on substantiating the device's performance through comparison with a predicate device and diagnostic accuracy for dry eye disease. The acceptance criteria are implicitly derived from these performance metrics.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance | Study Section |
|---|---|---|---|
| Precision | Consistent osmolarity measurements across various conditions (within-run, between-instrument, lot-to-lot, between-site) with low variability. | Single Instrument (CV%): Low: 1.34%, Normal: 1.85%, Moderate: 1.41%, High: 1.30% (Within Run); Low: 1.87%, Normal: 2.47%, Moderate: 2.08%, High: 2.33% (Total) | Section VI, Precision Studies, 1 |
| Between Instrument (CV%): Normal: 1.64%, Moderate: 1.68% | Section VI, Precision Studies, 2 | ||
| Lot-to-Lot (CV%): Low: 1.39%, Normal: 1.65%, Moderate: 2.15%, High: 2.28% | Section VI, Precision Studies, 3 | ||
| Between Site (CV%): Low: 1.59%, Normal: 2.09%, Moderate: 2.05%, High: 2.61% | Section VI, Precision Studies, 4 | ||
| Method Comparison (Internal) vs. Predicate (Wescor 5520 Vapro® Osmometer) | Strong correlation and agreement with the predicate device. | Regression Equation: y = 0.9146x + 23.061 | Section VI, Internal Method Comparison |
| Concordance Coefficient: 0.9588 | Section VI, Internal Method Comparison | ||
| R-squared: 0.9443 (from scatter plot) | Page 3, Figure 5 | ||
| Method Comparison (External) vs. Predicate (Wescor 5520 Vapro® Osmometer) | Strong correlation and agreement with the predicate device in external settings. | Regression Equation: y = 0.9402x + 12.512 | Section VI, External Method Comparison |
| R-squared: 0.9515 (from scatter plot) | Page 4, Figure 4 | ||
| Diagnostic Performance for Dry Eye Disease | Adequate sensitivity and specificity for dry eye disease diagnosis. | Sensitivity: 64% | Section VI, Performance on patients with objective signs of dry eye, Table 2 |
| Specificity: 71% | Section VI, Performance on patients with objective signs of dry eye, Table 2 | ||
| PPV (Positive Predictive Value): 82% | Section VI, Performance on patients with objective signs of dry eye, Table 2 | ||
| NPV (Negative Predictive Value): 48% | Section VI, Performance on patients with objective signs of dry eye, Table 2 |
2. Sample Size Used for the Test Set and Data Provenance
- Precision Studies: Contrived tear specimens across concentrations of 275–400 mOsms/L were used. The number of individual measurements or specimens per run/instrument/lot/site is not explicitly stated, but "Tear samples were analyzed over 20 consecutive days" for single instrument precision, and "Seven levels of contrived tear solution" for method comparison studies.
- Performance on Patients with Objective Signs of Dry Eye: 140 subjects (45 Normal, 95 Dry Eye) were enrolled.
- Data Provenance:
- Precision Studies: Not explicitly stated, but likely laboratory-controlled settings given the use of "contrived tear specimens."
- Method Comparison Studies (Internal & External): "Seven levels of contrived tear solution" were prepared. The external comparison was done "At each of three physician office sites."
- Performance on Patients with Objective Signs of Dry Eye: "multicenter study." Country of origin is not specified but given the FDA 510(k) submission, it is likely that studies complied with US regulations. The study appears to be prospective for collecting data on device performance with human subjects.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- For the "Performance on patients with objective signs of dry eye" study:
- Ground truth for "Dry Eye patient" vs. "Normal" was established based on clinical criteria: a positive score on the Ocular Surface Disease Index (OSDI) and 2 or more positive indications from a set of tests (Tear Film Breakup Time (TBUT), Schirmer Test, Corneal Staining, Conjunctival Staining, or Meibomian Gland Dysfunction).
- The number and qualifications of experts (e.g., ophthalmologists, optometrists) involved in performing these diagnostic tests and classifying subjects are not explicitly mentioned in the provided text.
4. Adjudication Method for the Test Set
The adjudication method for categorizing subjects as "Normal" or "Dry Eye" in the clinical performance study is based on a fixed set of objective and subjective clinical criteria (OSDI score and 2+ positive indications from a list of tests). It does not appear to involve a consensus process among multiple independent human readers in the traditional sense of image interpretation, but rather the application of established clinical definitions.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study assessing how much human readers improve with AI vs. without AI assistance was not conducted or reported. This device is a standalone diagnostic measurement system, not an AI-assisted interpretation tool for human readers.
6. Standalone Performance Study
Yes, a standalone performance study of the algorithm (the TearLab Osmolarity System) was conducted. This is evidenced by:
- Precision Studies: Demonstrated the device's consistency and reproducibility in measuring osmolarity (Section VI, Precision Studies).
- Method Comparison Studies: Compared the TearLab system's measurements directly against the predicate Wescor 5520 Vapro® Osmometer (Section VI, Internal Method Comparison, External Method Comparison).
- Performance on Patients with Objective Signs of Dry Eye: Evaluated the device's diagnostic accuracy (sensitivity, specificity, PPV, NPV) against clinically established ground truth for dry eye disease, without human intervention in the osmolarity measurement itself (Section VI, Performance on patients with objective signs of dry eye).
7. Type of Ground Truth Used
- Precision and Method Comparison Studies: For these studies, the ground truth was based on contrived tear specimens with known or established osmolarity values, often referenced against a gold standard osmometer (Wescor 5520 Vapro® Osmometer).
- Performance on Patients with Objective Signs of Dry Eye: The ground truth for classifying patients as "Normal" or "Dry Eye" was established through a consensus of clinical evaluation criteria, specifically a positive score on the Ocular Surface Disease Index (OSDI) and 2 or more positive indications from a combination of Tear Film Breakup Time (TBUT), Schirmer Test, Corneal Staining, Conjunctival Staining, or Meibomian Gland Dysfunction. This represents clinically defined outcomes/indicators.
8. Sample Size for the Training Set
The document does not explicitly mention a training set in the context of machine learning or AI algorithm development. The TearLab Osmolarity System uses an "electrical impedance measurement to provide an indirect assessment of osmolarity," and "after applying a lot-specific calibration curve, osmolarity is calculated." This suggests a deterministic algorithm or a model that uses calibration data rather than a machine learning model that requires a distinct "training set" in the common sense.
The "calibration data" mentioned refers to a meta-analysis of historical published data (n=1,436 subjects: 815 normal, 621 dry eye) which was used to determine an osmolarity referent (316 mOsms/L) and its associated sensitivity and specificity for dry eye diagnosis, but this was not for training the device's core osmolarity measurement algorithm. It was for establishing diagnostic thresholds based on osmolarity values, not for training the device's internal impedance-to-osmolarity conversion.
9. How the Ground Truth for the Training Set Was Established
As noted above, a distinct "training set" for an AI algorithm is not explicitly described. However, if considering the "calibration data" from the meta-analysis as a form of reference data to establish clinical thresholds:
- Meta-analysis Ground Truth: The ground truth for the meta-analysis (n=1,436) was derived from "historical published data" on tear osmolarity in normal and dry eye subjects using "earlier osmolarity devices." This implies that the classification of "Normal" or "Dry Eye" in those historical studies would have been based on their respective clinical diagnostic criteria prevalent at the time. Further details on how this ground truth was established within the original studies are not provided in this document.
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Section VI
OcuSense, Inc., TearLab Osmolarity System
1 4 2009
510(k) Summary Intended Use & Indications for Use
OcuSense, Inc. 12707 High Bluff Drive, Suite 200 San Diego, CA 92130
Phone: (858) 794-1422 Facsimile: (858) 794-1493 Contact Person: Michael Berg, VP Clinical & Regulatory Operations Date Prepared: May 5, 2009
Name of Device: TearLab™ Osmolarity System
Name/Address of Sponsor: OcuSense, Inc., 12707 High Bluff Drive, Suite 200, San Diego, CA 92130
Common or Usual Name: Osmometer
Classification Name: Osmometer for Clinical Use
Predicate Devices:
-
Wescor, Inc., 5520 Vapro® Vapor Pressure Osmometer (Class 1, Exempt)
-
Alcon Laboratories, Inc., Schirmer Tear Test (Class I, Exempt)
-
- Touch Scientific, Inc., Touch Tear IgE Microassay Kit (Class II, K991316)
-
- Dia-Screen Corp., Diascreen Reagent Strips (Class I, Non-exempt, K971976)
Intended Use & Indications for Use:
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.
Image /page/0/Picture/18 description: The image shows the word "OcuSense" in a stylized font. The word is slightly curved upwards, with a line underneath the left and right sides of the word. The font appears to be a serif font, and the letters are all connected.
Tear Testing Made Simple™
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Section VI 510(k) Summary Technological Characteristics
Device Description
The TearLab Osmolarity System is intended to measure the osmolarity of human tears to aid in the cliagnosis of patients with signs or symptoms of dry eye disease, in conjunction with other methods of clinical evaluation. The device consists of the following components and accessories: One Tearl.ab Reader, Two TearLab Pens, Two TearLab Electronic Check Cards, Sinqle Use TearLab Osmolarity Test Cards, and TearLab Control Solutions.
The TearLab Osmolarity Test Card, in conjunction with the TearLab Osmolarity System, provides a quick and simple method for determining tear osmolarity using nanoliter (nL) volumes of tear fluid collected directly from the eyelid margin.
To perform a test, a new Test Card containing a microfluidic capillary channel is attached onto the Pen. The tip of the Test Card is touched to the inferior tear meniscus located above the lower eyelid and collects 40-50 nanoliters of tear fluid by passive capillary action.
After a successful collection, the Pen in conjunction with the electrodes embedded on the Test Card, measures and stores the tear fluid impedance. The Pen is then docked to the Reader.
The Reader downloads impedance data from the Pen in order to calculate and display the final osmolarity as a numerical value displayed in units of mOsms/L.
The TearLab Osmolarity System simplifies the tear collection process by reducing the required specimen volume to nanoliters, eliminating the need to transfer tear fluid and reducing the risk of evaporation.
Principles of the Procedure
The TearLab Osmolarity test utilizes an electrical 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
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Precision Studies
Contrived tear specimens distributed across the clinical range of interest', 275– 400 mOsms/L, were used for performance testing (see Section XIX, Rationale for Use of Contrived Tears during Performance Testing).
1. Single Instrument Precision
Precisions calculated as defined in CLS/EPS-A2, Evaluation of Precision Performance of Quantitative Measurement Methods. Tear samples were analyzed over 20 consecutive days
| Sample | AverageOsmolarity(mOsms/L) | Within Run(SD) | Within Run(CV%) | Total(SD) | Total(CV%) |
|---|---|---|---|---|---|
| Low | 280 | 3.8 | 1.34% | 5.2 | 1.87% |
| Normal | 294 | 5.5 | 1.85% | 7.3 | 2.47% |
| Moderate | 316 | 4.5 | 1.41% | 6.6 | 2.08% |
| High | 345 | 4.5 | 1.30% | 8.0 | 2.33% |
2. Between Instrument Precision
One site, five instruments
| Sample | MeanOsmolarity | Total(SD) | Total(CV%) |
|---|---|---|---|
| Normal | 296 | 4.9 | 1.64% |
| Moderate | 316 | 5.3 | 1.68% |
3. Lot-to-Lot Precision
One site, three lots
| Sample | Lot 1 | Lot 2 | Lot 3 | MeanOsmolarity | Total(SD) | Total(CV%) |
|---|---|---|---|---|---|---|
| Low | 279 | 276 | 277 | 277 | 3.8 | 1.39% |
| Normal | 295 | 296 | 291 | 294 | 4.9 | 1.65% |
| Moderate | 307 | 303 | 301 | 304 | 6.5 | 2.15% |
| High | 338 | 326 | 324 | 329 | 7.5 | 2.28% |
4. Between Site Precision
Three sites, three instruments & four lots
| Sample | AverageOsmolarity | Total(SD) | Total(CV%) |
|---|---|---|---|
| Low | 278 | 4.4 | 1.59% |
| Normal | 289 | 6.0 | 2.09% |
| Moderate | 308 | 6.3 | 2.05% |
| High | 336 | 8.8 | 2.61% |
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Internal Method Comparison
Seven levels of contrived tear solution, distributed throughout the clinically significant range of osmolarity', were prepared and measured on the predicate Wescor 5520 Vapro® Osmometer and the TearLab Osmolarity System. The Deming regression between the individual Wescor values (x) and individual Tearlab values (y) is shown below. The red dotted line represents a line with a slope of 1.0.
| Parameter | Coefficient | Std Error | 95%CI |
|---|---|---|---|
| Intercept | 23.061 | 8.470 | 6.201 to 39.920 |
| Slope | 0.9146 | 0.0276 | 0.8597 to 0.9694 |
| Concordance coefficient | 0.9588 | ||
| Regression Equation | y=0.9146x + 23.061 |
Internal Method Comparison - TearLab vs. Wescor Osmolarity
Image /page/3/Figure/5 description: This image is a scatter plot comparing TearLab Osmolarity and Wescor Osmolarity. The x-axis represents Wescor Osmolarity, and the y-axis represents TearLab Osmolarity, both ranging from 260 to 400. A regression line is plotted through the data points, with the equation y = 0.9146x + 23.061 and an R-squared value of 0.9443, indicating a strong positive correlation between the two variables.
18 - Confidential
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External Method Comparison
At each of three physician office sites, forty contrived tear specimens across seven levels of the clinically significant range were prepared and measured on the TearLab Osmolarity System. The physician office laboratories did not have access to the Wescor 5520 Vapro® vapor pressure osmometer. Wescor values were determined by an average of 2-3 measurements on each level of osmolarity immediately prior to the beginning of the study.
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Image /page/4/Figure/4 description: This image is a scatter plot comparing TearLab Osmolarity and Wescor Osmolarity. The x-axis represents Wescor Osmolarity, ranging from 260 to 400, while the y-axis represents TearLab Osmolarity, also ranging from 260 to 400. The plot includes a regression line with the equation y = 0.9402x + 12.512 and an R-squared value of 0.9515, indicating a strong positive correlation between the two osmolarity measurements.
External Method Comparison - TearLab vs. Wescor Osmolarity
19 - Confidential
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Expected Values & Reference Ranqes
Reference tear osmolarity values for normal and dry eve disease patients: Normal: 288-331 mOsms/L (90% Cl 288-331, mean 309.9 ± 11.0) Dry Eye Disease: 291-382 mOsms/L (90% Cl 284-392, mean 324 ± 20.8) Osmolarity may differ from left and right eye, and each eye should be tested and assessed to determine which eye represents the higher osmolarity.
Calibration Data
To determine clinical performance for tear film hyperosmolarity in the diagnosis of Dry Eye Disease (DED) a meta-analysis was performed on historical published data for tear osmolarity in samples of normal and dry eye subjects. An osmolarity referent 316 mOsms/L was found to yield sensitivity of 69%, specificity of 92%, and an overall predictive accuracy of 82% for the diagnosis of dry eye syndrome. Studies in the meta-analysis used earlier osmolarity devices, not TearLab.
Table 1. Performance of Osmolarity in meta-analysis
| Normal | Dry Eye | Total | |||
|---|---|---|---|---|---|
| ≤ 316 | 750 | 192 | 942 | 80% | NPV |
| > 316 | 65 | 429 | 494 | 87% | PPV |
| Total | 815 | 621 | 1,436 | ||
| Specificity | Sensitivity | Accuracy | |||
| 92% | 69% | 82% |
[ Lominson A, Khanal S, Ramaesh K, Diaper C, McFadyen A. Tear Film Osmolality: Determination of a Referent for Iny Eve Diacrosis; Investigative Ophthalmology & Visual Science, October 2006; 47(10) 4309-4315]
Performance on patients with objective signs of dry eye
140 subjects were enrolled in a multicenter study (n = 45 Normal, n = 95 Dry Eye). To qualify as a Dry Eye patient, subjects were required a positive score on the Ocular Surface Disease Index (OSDI) and 2 or more positive indications of Tear Film Breakup Time (TBUT), Schirmer Test, Corneal Staining, Conjunctival Staining, or Meibomian Gland Dysfunction. Performance of the TearLab™ Osmolarity System using these selection criteria are shown below in Table 2:
Table 2. TearLab Osmolarity Diagnostic Performance for Dry Eye Disease
| Normal | Dry Eye | Total | |||
|---|---|---|---|---|---|
| ≤ 316 | 32 | 34 | 66 | 48% | NPV |
| > 316 | 13 | 61 | 74 | 82% | PPV |
| Total | 45 | 95 | 140 | ||
| Specificity | Sensitivity | ||||
| 71% | 64% |
20 - Confidential
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Figure 1. Distribution of Osmolarities in Normal and Dry Eye Disease subjects.
Image /page/6/Figure/2 description: The image contains two plots comparing osmolarity in normal eyes versus dry eye disease. The first plot is a scatter plot showing individual osmolarity measurements for normal eyes and eyes with dry eye disease. The average osmolarity for normal eyes is around 309.9 mOsms/L, while the average osmolarity for dry eye disease is around 324.3 mOsms/L. The second plot shows the probability distribution of osmolarity for normal eyes and dry eyes, with normal eyes having a mean of 309.9 ± 11.0 and dry eyes having a mean of 324.3 ± 20.1.
Substantial Equivalence
The intended use of the TearLab Osmolarity System, like the predicate Wescor osmometer, is to measure the osmolarity of body fluid. Although the TearLab System is specifically indicated for use in the measurement of osmolarity of human tears, while the Wescor osmometer is indicated for use more generally in body fluids, the indications for use of the Wescor encompass the indications for use of the TearLab. In addition, compared to the other predicate devices, the TearLab System has similar indications for use in assessing human tears as the predicate Schirmer strips and Touch IgE microassay, which are also indicated for evaluation of human tears. The TearLab Osmolarity System has the same technological characteristics as its predicate devices, and any technological differences between the TearLab and the predicates do not raise new questions of safety or effectiveness. Performance data demonstrate that the TearLab is as safe and effective as the Predicate Devices. Thus, the TearLab Osmolarity System is substantially equivalent to other leqally marketed tear collection and measurement devices.
- 275-400 mOsms/L, ref: Tomlinson, A, Khanal, K, Ramaesh, C et al, Diaper et al, Tear Film Osmolarity: Determination of a Referent for Dry Eye Diagnosis. IOVS. 2006;47(10)
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OcuSense, Inc. c/o Janice M. Hogan Hogan & Hartson LLP 1835 Market St., 29th Floor Philadelphia, PA 19103
2 2009 llink
Re: K083184 Trade/Device Name: TearLab Osmolarity System Regulation Number: 21 CFR 862.1540 Regulation Name: Osmolality test system Regulatory Class: Class I Product Code: OND, JJX Dated: April 23, 2009 Received: April 23, 2009
Dear Ms. Hogan:
This letter corrects our substantially equivalent letter of Mav 14, 2009.
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 such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page - 2
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
C.H.
Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(k) Number (if known): K083184
Device Name: TearLab™ Osmolarity System
Indication For Use:
The TearLab Osmolarity System is intended to measure the osmolarity of human tears to aid in the diagnosis of dry eye disease in patients suspected of having dry eye disease, in conjunction with other methods of clinical evaluation.
Prescription Use _ X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Division Sign Off
Division Sign-Off Office of In Vitro'Diagnostic Device Evaluation and Safety
510(k) K083/84
Page 1 of 1
§ 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.