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Osmolality Of Tears

Page Type
Product Code
Definition
To measure the osmolality 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.
Physical State
Tear collection method and impendance measuring device.
Technical Method
Electrical impedance measurement to provide an indirect assessment of osmolality.
Target Area
Eye
Regulation Medical Specialty
Chemistry
Review Panel
Chemistry
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
862.1540
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 862.1540 Osmolality test system

§ 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.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000]

Osmolality Of Tears

Page Type
Product Code
Definition
To measure the osmolality 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.
Physical State
Tear collection method and impendance measuring device.
Technical Method
Electrical impedance measurement to provide an indirect assessment of osmolality.
Target Area
Eye
Regulation Medical Specialty
Chemistry
Review Panel
Chemistry
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
862.1540
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 862.1540 Osmolality test system

§ 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.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000]