JCE · Solution, Isotonic
Pathology · 21 CFR 864.4010 · Class 1
Overview
| Product Code | JCE |
|---|---|
| Device Name | Solution, Isotonic |
| Regulation | 21 CFR 864.4010 |
| Device Class | Class 1 |
| Review Panel | Pathology |
| GMP Exempt | Yes |
Identification
A general purpose reagent is a chemical reagent that has general laboratory application, that is used to collect, prepare, and examine specimens from the human body for diagnostic purposes, and that is not labeled or otherwise intended for a specific diagnostic application. It may be either an individual substance, or multiple substances reformulated, which, when combined with or used in conjunction with an appropriate analyte specific reagent (ASR) and other general purpose reagents, is part of a diagnostic test procedure or system constituting a finished in vitro diagnostic (IVD) test. General purpose reagents are appropriate for combining with one or more than one ASR in producing such systems and include labware or disposable constituents of tests; but they do not include laboratory machinery, automated or powered systems. General purpose reagents include cytological preservatives, decalcifying reagents, fixative and adhesives, tissue processing reagents, isotonic solutions and pH buffers. Reagents used in tests for more than one individual chemical substance or ligand are general purpose reagents (e.g., Thermus aquaticus (TAQ) polymerase, substrates for enzyme immunoassay (EIA)).
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K842722 | BUFFERED SALINE | E K Ind., Inc. | Sep 11, 1984 | SESE |
| K831200 | IMMUNOHEMATOLOGICAL SALINE #97139 | Emd Chemicals, Inc. | May 9, 1983 | SESE |
| K801506 | CERTIFIED BLOOD BANK SALINE | Nobel Scientific Industries, Inc. | Jul 28, 1980 | SESE |
| K792101 | COUITER/CMS ISOTONIC BLOOD BANK SALINE | Coulter Electronics, Inc. | Nov 20, 1979 | SESE |
| K761183 | LYSING AGENT AF | Central Labs. Assoc. MD Pathologists | Jan 17, 1977 | SESE |
| K761174 | PHYSIOLOGIC SALINE (0.85%) | Bio/Data Corp. | Jan 10, 1977 | SESE |
| K761170 | BARBITAL SALINE BUFFER | Bio/Data Corp. | Jan 10, 1977 | SESE |
Top Applicants
- Bio/Data Corp. — 2 clearances
- Central Labs. Assoc. MD Pathologists — 1 clearance
- Coulter Electronics, Inc. — 1 clearance
- E K Ind., Inc. — 1 clearance
- Emd Chemicals, Inc. — 1 clearance
