FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The SPIFE LD test system can be used in conjunction with CK isoenzyme studies to aid in the diagnosis of myocardial infarction. The LD1/LD2 "flip" can be present in patients after acute MI, severe anemias, renal necrosis and in-vivo or in-vitro hemolysis of any cause.

The LD5 is increased in skeletal muscle injury or diseases, cirrhosis, hepatitis and passive liver congestion.

Mid-zone fractions (LD2,3,4) are increased in cases of massive platelet destruction (pulmonary embolism) and in lymphatic system involvements such as mononucleosis, lymphomas and lymphocytic leukemias.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided text, there is no information about the acceptance criteria or the study that proves the device meets specific performance criteria. The document is a 510(k) clearance letter from the FDA for a device called "SPIFE LD-12 Isoenzyme Kit."

This letter primarily focuses on:

Substantial Equivalence: Stating that the device is substantially equivalent to a legally marketed predicate device.
Regulatory Classification: Identifying the regulation number, name, and regulatory class (Class II).
General Controls: Informing the manufacturer about applicable general controls provisions of the Federal Food, Drug, and Cosmetic Act.
Marketing Authorization: Granting permission to market the device.
Indications for Use: Briefly describing the intended use of the device in relation to diagnostic conditions such as myocardial infarction, skeletal muscle injury, and lymphatic system involvements.

The document does not contain data tables, sample sizes for test or training sets, details on ground truth establishment, expert qualifications, adjudication methods, or results from any performance studies (standalone or MRMC).

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K Number

K020467

Device Name

SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452

Manufacturer

HELENA LABORATORIES

Date Cleared

2002-03-29

(45 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Intended Use

The SPIFE LD test system can be used in conjunction with CK isoenzyme studies to aid in the diagnosis of myocardial infarction. The LD1/LD2 "flip" can be present in patients after acute MI, severe anemias, renal necrosis and in-vivo or in-vitro hemolysis of any cause.

The LD5 is increased in skeletal muscle injury or diseases, cirrhosis, hepatitis and passive liver congestion.

Mid-zone fractions (LD2,3,4) are increased in cases of massive platelet destruction (pulmonary embolism) and in lymphatic system involvements such as mononucleosis, lymphomas and lymphocytic leukemias.

Device Description

Not Found

AI/ML Overview

I am sorry. I cannot answer your question. The document does not contain the information requested in your query. The document is an FDA 510(k) clearance letter for the "SPIFE LD Vis Isoenzyme Kit" and primarily discusses the regulatory approval, classification, and indications for use of the device. It does not provide details about acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment for performance evaluation.

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K Number

K970477

Device Name

HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT

Manufacturer

SEBIA

Date Cleared

1997-03-10

(31 days)

Product Code