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Last synced on 27 June 2025 at 11:06 pm
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subpart-d—serological-reagents/
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Fish (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp.

Page Type
Product Code
Definition
The Plasmodium sp. FISH is intended to detect Plasmodium spp. parasites and/or differentiate parasite species in clinical whole blood smear specimens from patients with signs or symptoms of malaria and suspicion of infection.
Physical State
In vitro diagnostic devices and reagents that consist of slides, fixatives, fluorescently labeled probes, buffers, and associated instrumentation (if applicable) for the detection and identification of Plasmodium spp. parasites in clinical whole blood smear specimens.
Technical Method
Fluorescence In Situ Hybridization using labeled nucleic acid probes
Target Area
Target Area Clinical whole blood smear specimens from patients suspected of infection with Plasmodium spp.
Regulation Medical Specialty
Microbiology
Review Panel
Microbiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
866.3367
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible
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CFR § 866.3367 Device to detect and identify microbial nucleic acids by FISH in clinical specimens

§ 866.3367 Device to detect and identify microbial nucleic acids by FISH in clinical specimens.

(a) Identification. A device to detect and identify microbial nucleic acids by fluorescence in situ hybridization (FISH) in clinical specimens is an in vitro diagnostic device intended for the detection and identification of microbial pathogens in specimens collected from patients with signs and symptoms of infection. The device is intended to aid in the diagnosis of human disease in conjunction with clinical signs and symptoms and other laboratory findings.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Design verification and validation must include the following:

(i) Detailed device description documentation, including the device components, instrument requirements, ancillary reagents required but not provided, and a detailed explanation of the methodology, including all pre-analytical methods for processing of specimens, probe sequences, and rationale for probe sequence selection;

(ii) Detailed description of the fluorophores, signal source, detection mechanism, and method of result interpretation;

(iii) Detailed documentation from the following analytical studies: analytical sensitivity (Limit of Detection), inclusivity, reproducibility, interference, cross reactivity, and specimen stability; and

(iv) Detailed documentation from a clinical study that includes prospective (sequential) samples. The study, performed on a study population consistent with the intended use population, must compare the device performance to results obtained from appropriate and well-accepted comparator methods.

(2) The labeling required under § 809.10(b) of this chapter must include:

(i) A statement that the device is intended to be used in conjunction with clinical history, signs, symptoms, and the results of other diagnostic testing;

(ii) A detailed explanation of the interpretation of results and acceptance criteria for any quality control testing; and

(iii) A limitation that negative results do not preclude the possibility of infection.

[90 FR 19638, May 9, 2025]

FDA Browser

by Innolitics

MI/
subpart-d—serological-reagents/
PYN
View Source

Fish (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp.

Page Type
Product Code
Definition
The Plasmodium sp. FISH is intended to detect Plasmodium spp. parasites and/or differentiate parasite species in clinical whole blood smear specimens from patients with signs or symptoms of malaria and suspicion of infection.
Physical State
In vitro diagnostic devices and reagents that consist of slides, fixatives, fluorescently labeled probes, buffers, and associated instrumentation (if applicable) for the detection and identification of Plasmodium spp. parasites in clinical whole blood smear specimens.
Technical Method
Fluorescence In Situ Hybridization using labeled nucleic acid probes
Target Area
Target Area Clinical whole blood smear specimens from patients suspected of infection with Plasmodium spp.
Regulation Medical Specialty
Microbiology
Review Panel
Microbiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
866.3367
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible
View Source

CFR § 866.3367 Device to detect and identify microbial nucleic acids by FISH in clinical specimens

§ 866.3367 Device to detect and identify microbial nucleic acids by FISH in clinical specimens.

(a) Identification. A device to detect and identify microbial nucleic acids by fluorescence in situ hybridization (FISH) in clinical specimens is an in vitro diagnostic device intended for the detection and identification of microbial pathogens in specimens collected from patients with signs and symptoms of infection. The device is intended to aid in the diagnosis of human disease in conjunction with clinical signs and symptoms and other laboratory findings.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Design verification and validation must include the following:

(i) Detailed device description documentation, including the device components, instrument requirements, ancillary reagents required but not provided, and a detailed explanation of the methodology, including all pre-analytical methods for processing of specimens, probe sequences, and rationale for probe sequence selection;

(ii) Detailed description of the fluorophores, signal source, detection mechanism, and method of result interpretation;

(iii) Detailed documentation from the following analytical studies: analytical sensitivity (Limit of Detection), inclusivity, reproducibility, interference, cross reactivity, and specimen stability; and

(iv) Detailed documentation from a clinical study that includes prospective (sequential) samples. The study, performed on a study population consistent with the intended use population, must compare the device performance to results obtained from appropriate and well-accepted comparator methods.

(2) The labeling required under § 809.10(b) of this chapter must include:

(i) A statement that the device is intended to be used in conjunction with clinical history, signs, symptoms, and the results of other diagnostic testing;

(ii) A detailed explanation of the interpretation of results and acceptance criteria for any quality control testing; and

(iii) A limitation that negative results do not preclude the possibility of infection.

[90 FR 19638, May 9, 2025]